Reported trial results for Atrial Fibrillation

72 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05443594 · results posted 24 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05443594) looked at a procedure called pulsed field ablation (PFA) for people with a heart rhythm condition. The trial ran in two phases — Phase 1 included 355 participants and Phase 2 included 314 participants. Not everyone completed the full study period: 325 finished in Phase 1 and 290 in Phase 2. The trial was measuring two main things: how often certain unwanted medical events occurred after the procedure, and how many participants met a definition of "treatment success" at 360 days after the procedure. The reported data shows that, for the safety measure, 2.3% of Phase 1 participants and 2.4% of Phase 2 participants experienced one of a defined list of unwanted medical events (such as stroke, cardiac tamponade, or complications at the access site) within the specified timeframes. For the main measure of success at 360 days — which combined both how the procedure went on the day and whether certain heart rhythm problems, repeat procedures, or certain medications were needed afterwards — the reported figures were 63.5% for Phase 1 and 73.4% for Phase 2. Some additional measures were also reported: nearly all participants in both phases (99.6% in each) met the definition of success on the day of the procedure itself. When looking only at freedom from symptoms and further interventions (not counting cases where abnormal rhythm was detected but caused no symptoms), the reported figures were 85.3% for Phase 1 and 81.0% for Phase 2. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05809596 · results posted 15 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05809596) enrolled 500 participants in a single group called the "Primary Analysis Subset." The trial was looking at a medical device — specifically measuring two things: first, whether there were any gaps or leaks around the device at 45 days after it was implanted (checked using a heart imaging scan called a TEE, or transoesophageal echocardiogram); and second, tracking a combined count of serious events — including death from any cause, stroke, blood clots travelling through the body, and major bleeding — over six months. Of the 500 people who started, 494 reached the 45-day check-in and 474 completed the full six-month follow-up. The reported data shows that, of the participants who had the 45-day imaging scan, zero (0) were found to have a gap or leak around the device that was larger than 5 millimetres. For the six-month safety measurement, the reported data shows that 54 participants experienced at least one of the serious events in the combined (composite) count — this included any death, stroke, travelling blood clot, or major bleeding event across the group. The data does not break down how many of those 54 experienced each individual event type separately, so those figures were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03795298 · results posted 18 September 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03795298) enrolled 1,600 people in total — 797 in a group taking oral anticoagulants (blood-thinning tablets, used as the comparison group) and 803 who received a small implantable device called the WATCHMAN FLX, which is placed inside the heart to block a small pouch where blood clots can form. The trial was measuring two main things: first, how many people in each group experienced a stroke, died from any cause, or had a blood clot travel to another part of the body; and second, how many people experienced significant bleeding that was not related to the implant procedure itself. The reported data shows that for the first main measure — stroke, death from any cause, or travelling blood clots — 44 participants in the oral anticoagulant group and 41 participants in the WATCHMAN FLX group experienced one of these events. For the second main measure — significant non-procedure-related bleeding — 137 participants in the oral anticoagulant group and 65 participants in the WATCHMAN FLX group recorded such an event. The reported data also shows a secondary (additional) measure looking specifically at serious bleeding, including any bleeding linked to the implant procedure itself: 38 participants in the oral anticoagulant group and 30 participants in the WATCHMAN FLX group experienced this. It is important to note that these numbers describe what was counted and recorded during the trial — they do not on their own tell us whether one approach is better or worse than the other, as that requires more detailed statistical analysis that was not included in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04229472 · results posted 19 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04229472) enrolled participants across three groups: a Normal Subject Control Group, an Atrial Fibrillation Group, and an AcQMap Atrial Fibrillation Group. No participants were recorded as starting or completing the study in the Normal Subject Control Group. In the Atrial Fibrillation Group, 20 people started and 19 completed the study. In the AcQMap Atrial Fibrillation Group, 11 people started and 10 completed. The trial was focused on measuring electrical signals in the upper chambers of the heart — specifically looking at the size (voltage amplitude) of those signals and how they changed under different pacing conditions (where the heart is stimulated at different speeds). The reported data shows that for the primary outcome — measuring the average voltage amplitude (a way of describing the strength of electrical signals, measured in millivolts, or mV) in the left atrium (the upper-left chamber of the heart) — the Atrial Fibrillation Group recorded a mean of 2.00 mV, and the AcQMap Atrial Fibrillation Group recorded a mean of 1.92 mV. No numerical results were reported for any of the secondary or other pre-specified outcomes, which looked at how electrical signal shape, strength, and the speed signals travel through heart tissue changed at different pacing speeds. The data for these outcomes was not reported in the ClinicalTrials.gov submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04926857 · results posted 1 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04926857) enrolled 973 people who already had a small heart-monitoring device — called a LINQ implantable cardiac monitor (ICM) — placed under their skin to continuously track their heart rhythm. The trial was measuring whether data collected by these devices could be used to predict when a person with atrial fibrillation (AF — an irregular heartbeat condition) was more likely to have a healthcare visit, such as a hospital admission, emergency department visit, or clinic appointment, where AF was a reason for that visit. Of the 973 people who started, 864 completed the study, and 109 did not complete it. The reported data shows that researchers built a predictive model — essentially a mathematical tool that looks for patterns in the device data to forecast future healthcare visits. The model was trained on data from 70% of participants and then tested on the remaining 30%. Its performance was measured using something called an AUROC (Area Under the Receiver Operating Curve), which is a score between 0 and 1 that reflects how well the model can tell apart people who will have an AF-related healthcare visit from those who won't — with 1.0 being a perfect score and 0.5 being no better than chance. The reported AUROC score in the testing group was **0.76**. No other outcome measures were included in the submitted results data, so no further figures are available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04755283 · results posted 30 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04755283) enrolled 1,287 people in total — 427 in the abelacimab 90 mg group, 430 in the abelacimab 150 mg group, and 430 in the rivaroxaban group. The trial was measuring and comparing rates of bleeding events across the three groups. Rivaroxaban is an existing blood-thinning medicine, and abelacimab (MAA868) is an investigational medicine being studied in two different doses. The main thing the trial tracked was how often participants experienced a significant bleeding episode — either a "major bleed" (a serious bleed meeting specific medical criteria) or a "clinically relevant non-major bleed" (a bleed that needed medical attention but did not meet the most serious threshold). The reported data shows the primary outcome — the rate of major or clinically relevant non-major bleeding combined — was 2.64 events per 100 person-years in the abelacimab 90 mg group, 3.22 events per 100 person-years in the abelacimab 150 mg group, and 8.39 events per 100 person-years in the rivaroxaban group. (The term "per 100 person-years" is simply a way of counting how many events occurred for every 100 participants followed for one year, allowing fair comparisons between groups.) For major bleeds alone, the reported rates were 0.99, 1.22, and 3.73 per 100 person-years respectively. When minor bleeds were also included alongside the other two categories, the reported rates were 7.05, 10.43, and 15.30 per 100 person-years for the 90 mg, 150 mg, and rivaroxaban groups respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05476250 · results posted 13 May 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 120 participants who were enrolled to test a Masimo sensor device (called INVSENSOR00057) and its ability to detect atrial fibrillation — an irregular heartbeat condition. Of the 120 people who started the trial, 99 completed it, while 21 did not complete it (the reasons were not reported in the data provided). The trial's main measurement focused on something called "specificity" — this means how often the device correctly identified people who did *not* have atrial fibrillation, without incorrectly flagging them as having it. The reported data shows that the device returned a specificity score of 100%, meaning that, among the participants measured, every person who did not have atrial fibrillation was correctly identified as such, with no false positives reported. It is worth noting that the data provided only covers this one specific measurement — no other outcome results were reported in the structured data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03973931 · results posted 2 April 2025

  According to the results reported on ClinicalTrials.gov, this trial enrolled 9,501 participants across four groups. Three groups received different types of digital "nudges" — automated messages designed to encourage people to pick up their prescription medications — while a fourth group received usual care with no extra prompts. The nudge approaches tested were: a general nudge, an optimised (more personalised) nudge, and an optimised nudge combined with an AI chat bot. The main thing being measured was how consistently people collected their medications over time, using pharmacy refill records to calculate what is called the "proportion of days covered" (PDC) — essentially, out of all the days in the study period, on how many days was a person estimated to have had their medication available to them. The reported data shows that across all four groups, PDC scores were fairly similar. The usual care group had a mean PDC of 0.630, the optimised nudge plus AI chat bot group 0.623, the optimised nudge group 0.620, and the general nudge group 0.606. When compared directly to the usual care group, the reported differences in PDC were small: the general nudge group was about 0.022 higher, the optimised nudge group about 0.020 higher, and the optimised nudge plus AI chat bot group about 0.023 higher. For the secondary outcomes — estimated chances of hospitalisation, emergency department visits, and death over one year — the reported data shows similarly close figures across all four groups. For example, the estimated probability of hospitalisation ranged from 0.130 (general nudge) to 0.143 (usual care), and the estimated probability of an emergency department visit ranged from 0.285 to 0.301 across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02618577 · results posted 6 February 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT02618577) enrolled 1,306 people in the edoxaban group and 1,302 people in the aspirin-or-placebo group — a total of 2,608 participants. The trial was measuring how often people experienced a stroke, a blood clot travelling to another part of the body (called systemic embolism), or death from a cardiovascular (heart or blood vessel) cause. It also tracked a number of secondary outcomes, including major heart events, death from any cause, serious bleeding, and quality of life. The reported data shows the main (primary) outcome — the combined rate of stroke, systemic embolism, or cardiovascular death — was 3.3 events per 100 patient-years in the edoxaban group and 4.0 events per 100 patient-years in the aspirin-or-placebo group. (A "patient-year" is a way of accounting for the fact that people were followed for different lengths of time.) For strokes alone, the reported figures were 0.9 versus 1.1 events per 100 patient-years. For major heart events (cardiac death, heart attack, or acute coronary syndrome), the reported rates were 3.6 versus 4.1 per 100 patient-years. Death from any cause was reported as 4.3 per 100 patient-years in the edoxaban group and 3.7 in the comparator group. Serious bleeding events were reported as 2.1 per 100 patient-years in the edoxaban group and 1.0 in the comparator group. For quality of life, both groups showed very small declines from their starting scores across all measures assessed, and the reported changes were similar between groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05089877 · results posted 13 January 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05089877) was a single-group study — meaning everyone received the same treatment with no comparison group — that enrolled 39 participants. The trial was looking at a procedure called cardiac ablation for abnormal heart rhythms (specifically atrial fibrillation, atrial flutter, or atrial tachycardia). Of the 39 people who started, 28 completed the study and 11 did not finish. The trial measured two main things: whether serious events such as death, stroke, heart attack, or major bleeding occurred within 30 days of the procedure, and whether participants remained free from abnormal heart rhythm episodes lasting longer than 30 seconds at their final follow-up visit, while not taking certain rhythm-controlling medications. The reported data shows that, for the first primary measure, zero out of the participants experienced the serious events (death, stroke, heart attack, or major bleeding) in the 30 days after the procedure. For the second primary measure, 25 out of 28 participants who completed the study were recorded as free from abnormal heart rhythm episodes at their last follow-up visit, as detected by a 24-hour heart-monitoring test (called a Holter monitor). The reported data for the secondary outcome measures — which included freedom from abnormal rhythms regardless of medication use, and whether normal heart rhythm was restored by the end of the procedure — were not reported in the data submitted to ClinicalTrials.gov. It is worth noting this was a small study with no comparison group, which limits what can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05072964 · results posted 17 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people who had a heart rhythm condition called paroxysmal atrial fibrillation (a type of irregular heartbeat that comes and goes) and who had already tried at least one medication without success. The trial was testing the FARAPULSE Pulsed Field Ablation System, a device used to treat the abnormal electrical signals in the heart. Of the 180 people who started, 175 completed the study and 5 did not. The trial measured two main things: how many participants remained free of treatment failure over 12 months, and how many experienced a set of predefined safety-related events over the same period. The reported data shows that, out of 180 participants, 121 were recorded as free of chronic treatment failure through 12 months — meaning their irregular heartbeat had not returned in a way that counted as a treatment failure under the trial's definition. Separately, 2 participants experienced what the trial defined as a composite safety endpoint (a pre-agreed list of specific health events) over the 12-month period. For the secondary outcomes, the reported data shows that 180 out of 180 participants had what the trial called acute procedural success — meaning the procedure appeared to achieve its immediate technical goal on the day it was performed. Regarding freedom from device- or procedure-related serious adverse events (unexpected health problems serious enough to require attention), the data shows figures of 173 and 179 participants across two reported measurements, though the data as submitted does not clearly distinguish what time points or subgroups these two figures separately represent. It is worth noting that this trial had only one group — everyone received the FARAPULSE device — so there was no comparison group reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01924065 · results posted 8 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 112 people with an irregular heart rhythm (atrial fibrillation) who were about to undergo a procedure called cardioversion (where the heart is reset back to a normal rhythm). Participants were split into two equal groups of 56. One group had a specialised heart ultrasound — called a transesophageal echocardiography, where a small probe is passed down the throat to get a close-up view of the heart — before their procedure. The other group received a course of blood-thinning medication (oral anticoagulants) beforehand. The trial followed participants for up to two years, and also used a type of brain scan (MRI) one week after cardioversion to look for any "silent" (symptom-free) signs of reduced blood flow to the brain. The reported data shows the following numbers across both groups. For the main combined measure — which counted blood clot events, bleeding events, deaths, or silent brain changes on MRI — 9 participants in the ultrasound group and 11 in the medication group reached this endpoint. Looking at each component separately: strokes or mini-strokes (transient ischemic attacks) were recorded in 7 people in the ultrasound group and 4 in the medication group. Silent brain changes detected on MRI occurred in 2 people in the ultrasound group and 4 in the medication group. Deaths were recorded for 3 people in the ultrasound group and 2 in the medication group. Bleeding on the brain (haemorrhagic stroke) was recorded for 1 person in the ultrasound group and 2 in the medication group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02697448 · results posted 20 August 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 135 people in total — 67 in the Propofol group and 68 in the Sevoflurane group. Both of these are types of anaesthetic (medicines used to keep patients unconscious during a procedure). The trial was comparing the two anaesthetics across a number of measurements, including how long the procedure took, how quickly patients could be taken off the breathing tube afterwards, and several recovery-related experiences the day after surgery such as pain, nausea or vomiting, and alertness. It also tracked whether participants experienced a return of an irregular heart rhythm called atrial fibrillation in the six months following the procedure. Of the 135 who started, 125 completed the trial (62 in the Propofol group and 63 in the Sevoflurane group), with 5 not completing in each group. The reported data shows the following numbers for the two main measurements: procedures in the Propofol group lasted an average of 159.2 minutes, compared to 170.7 minutes in the Sevoflurane group. For time taken to remove the breathing tube after the procedure ended (where a longer time is noted as a worse outcome), the Propofol group averaged 11 minutes and the Sevoflurane group averaged 8 minutes. For the additional measurements taken on the day after surgery: both groups rated their resting pain at 2 out of 10 on average (where 0 means no pain and 10 means the worst pain imaginable); 4 participants in each group reported experiencing nausea or vomiting; and both groups rated their alertness at 9 out of 10 on average (where 10 means back to normal). Regarding the return of atrial fibrillation over six months, the reported data shows counts of participants affected at multiple time points — 13 vs 12, then 12 vs 18, then 10 vs 17 (Propofol vs Sevoflurane respectively) — however, the specific time points these figures correspond to were not clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04096963 · results posted 12 August 2024

  According to the results reported on ClinicalTrials.gov, this trial looked at a device called the WATCHMAN FLX, which is implanted inside the heart to close off a small pouch called the left atrial appendage — an area where blood clots can form in people with a type of irregular heartbeat. The trial enrolled 50 participants in total, of whom 46 completed the study. The trial was measuring two main things: whether the device was closing that pouch properly, and whether certain serious events occurred shortly after the procedure. The reported data shows that, for the primary "effectiveness" measure — which tracked whether there was any significant leakage around the device (defined as a gap greater than 5mm, detected by imaging at the first follow-up) — the reported occurrence rate was 0%. For the primary "safety" measure — which tracked whether serious events such as death from any cause, stroke, or complications requiring major surgery occurred within 7 days of the procedure or before leaving hospital — the reported occurrence rate was 2.0%. For the secondary measure, which looked at the occurrence of ischaemic stroke (a stroke caused by a blood clot) or blood clots travelling elsewhere in the body over 12 months, the reported data shows 0 occurrences in one analysis group and 1 occurrence in a broader analysis group. The data does not explain further detail about these differing groups beyond their labels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03906461 · results posted 2 August 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03906461) enrolled 143 people and looked at how a heart procedure called radiofrequency ablation performed when using two specific tools together — the TactiCath SE catheter and a software feature called the Lesion Size Index (LSI). The LSI is a combined score that brings together how hard the catheter presses against the heart wall, how long the energy is applied, and how much electrical current is used, to give a single number representing how a heat-based scar (lesion) forms during the procedure. All 143 participants completed the procedure itself, and 133 of them completed the full 12-month follow-up period; 10 did not complete the follow-up, though the reason is not detailed in the data. The reported data shows that average LSI scores across eight different areas around the pulmonary veins (the veins connecting the lungs to the heart) ranged from 4.7 to 5.1. The secondary outcomes recorded various technical settings during the procedure. The average power of the radiofrequency energy delivered was reported as 38.0 watts. The average contact force — how firmly the catheter pressed against the tissue — was reported as 11.7 grams. The average spacing between individual burn marks was 5.7 millimetres, and various timing measures were reported as 14.4 seconds, 7.1 seconds, and 3.2 seconds. The reported data also shows that all 143 participants had electrical isolation of all pulmonary veins confirmed immediately after the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02731326 · results posted 3 July 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02731326) enrolled 131 people in the iHEART group and 131 people in the Usual Care group — 262 participants in total. The trial was measuring things related to an irregular heart rhythm condition called atrial fibrillation (AF), including how often the irregular rhythm came back, how long it took for those people to receive treatment, how many people needed treatment for a recurrence, participants' quality of life, and how much participants knew about their condition. The reported data shows the following for the three primary (main) outcomes. First, the rate at which the irregular heart rhythm returned was recorded as 0.132 episodes per person-month in the iHEART group and 0.091 episodes per person-month in the Usual Care group (a "person-month" simply means one person being followed up for one month). Second, the average time from detecting a recurrence to receiving treatment was reported as 43 days in the iHEART group and 33 days in the Usual Care group. Third, the number of participants who actually received treatment for a recurrence was 21 in the iHEART group and 35 in the Usual Care group. For the secondary (additional) outcomes, quality-adjusted life year scores — a way of measuring quality of life where 1.0 represents full health — were reported as 0.94 for iHEART and 0.91 for Usual Care. Knowledge about atrial fibrillation was measured on an 11-point scale; the reported change in scores from the start to six months was 0.27 points in the iHEART group and 0.17 points in the Usual Care group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04025710 · results posted 11 January 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 167 people in total, all placed into a single group. The trial was looking at a small heart-monitoring device (called BIOMONITOR III or BIOMONITOR IIIm) that is inserted under the skin to continuously record heart activity. Of the 167 people who started, 116 completed the study, while 51 did not finish. The primary outcome the trial was measuring was the number of participants who did not experience a "serious adverse device effect" (that is, a harmful event considered to be related to the device or its insertion procedure) within the first three months. The reported data shows that 141 out of 167 participants were free from such events up to the three-month follow-up point. The trial also set out to measure several secondary outcomes — including the strength of the heart's electrical signal picked up by the device, the amount of unwanted signal "noise" it recorded, the visibility of a particular part of the heart's signal called the P-wave, and the number of participants free from serious device-related events at 12 months. However, no numerical results for any of these secondary outcomes were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03455673 · results posted 22 December 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 3,160 people who all had atrial fibrillation (an irregular heartbeat condition). The trial was measuring whether a scoring tool called the "ATE score" — which stands for Atrial Thrombus Exclusion — could identify patients who had a blood clot inside the heart (called an atrial thrombus), as detected by a specialised heart scan called a transoesophageal echocardiogram. A score of zero on the ATE tool meant the patient had none of the listed risk factors, such as high blood pressure, heart failure, previous stroke, or an elevated blood marker called D-dimer. The reported data shows that, among the participants who received an ATE score (3,099 people), 816 scored zero on the ATE tool. Of those 816 people with a zero ATE score, 2 were found to have a heart clot, while 27 people who did have a clot received a score above zero. Overall, across all participants, 29 people were found to have a heart clot and 3,043 were not. The reported data also shows results for two other commonly used scoring tools. For the CHA₂DS₂-VASc score (a stroke-risk tool scored 0–10), 604 people scored zero, and of those, 3 had a clot detected. For the CHADS₂ score (another stroke-risk tool scored 0–6), 1,285 people scored zero, and of those, 4 had a clot detected. One participant's result was not allocated to either subgroup in each of those two comparisons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04198701 · results posted 13 December 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04198701) enrolled a total of 421 participants across four groups: a Pilot group (38 people), a Roll-In group (60 people), and two main study groups — one for people with a type of irregular heartbeat called paroxysmal AF (164 enrolled) and one for persistent AF (159 enrolled). The trial was looking at a heart procedure using a system called PulseSelect PFA (pulsed field ablation), which targets specific areas of the heart involved in abnormal electrical signals. The study measured both how many participants experienced certain serious unwanted medical events, and how many were considered to have had a successful treatment outcome over 12 months. The reported data shows that in the two main study groups, just 1 out of 150 participants in the paroxysmal AF group and 1 out of 150 in the persistent AF group experienced at least one of the pre-defined serious safety events tracked in the study. For the main effectiveness measure — which counted participants who did not experience any of several defined signs of treatment failure over 12 months — the reported data shows 100 out of 150 participants in the paroxysmal AF group and 83 out of 150 in the persistent AF group met this definition of treatment success. In the Pilot group, 0 out of 38 participants had a serious adverse event within 30 days, and all 38 had what was defined as an acute procedural success. The reported data also shows changes in quality-of-life scores between the start of the study and the 12-month mark. On a general health scale running from 0 to 1, both the paroxysmal AF group and the persistent AF group reported an average increase of 0.05 and 0.06 points respectively. On an AF-specific quality-of-life scale running from 0 to 100, both groups reported an average increase of around 29 points. These numbers reflect what participants reported on questionnaires; the data does not explain the reasons behind any changes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04187196 · results posted 13 November 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 73 people in total — 35 in a group given propofol (a sedative medicine) and 38 in a group given methohexital (another sedative medicine). Two participants in the propofol group did not complete the trial; everyone in the methohexital group did. The trial was looking at how quickly people recovered full awareness after being sedated, as well as a number of other time-related and physical measurements taken during and after the sedation procedure. The reported data shows that the main thing being measured — the time from when sedation began until a person was fully awake and able to answer simple questions like their name and age — was recorded as an average of 7.6 minutes for the propofol group and 5.5 minutes for the methohexital group. For the additional measurements: both groups took an average of 1.0 minutes from the end of the injection until they lost consciousness; the time until a medical shock was delivered was reported as 1.28 seconds (propofol) and 1.2 seconds (methohexital); and the time until participants first opened their eyes was 7.0 seconds (propofol) and 4.2 seconds (methohexital). Blood pressure readings (both the higher "systolic" number and the lower "diastolic" number) were recorded at multiple points during the procedure for both groups, with the reported data showing various figures across those time points — for example, systolic readings across the time points ranged from around 111 to 138 mmHg in the propofol group and from around 132 to 144 mmHg in the methohexital group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04356040 · results posted 31 October 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT04356040) enrolled people with a type of irregular heartbeat called paroxysmal atrial fibrillation (AF — where the heart rhythm comes and goes on its own). A total of 305 people took part in the main study, and a further 50 joined a related sub-study testing a slightly different approach using higher energy settings. All participants underwent a heart procedure using a catheter device called the TactiFlex SE, which uses radiofrequency (heat) energy to treat areas of the heart causing the irregular rhythm. The trial tracked participants for up to 12 months. It was measuring two main things: how many people experienced serious complications linked to the device or procedure within 7 days, and how many remained free from their irregular heart rhythm returning over the following year. The reported data shows that in the main study, 12 out of 305 participants experienced a serious adverse event (an unwanted medical event considered serious) linked to the device or procedure within 7 days; in the sub-study, 2 out of 50 participants had such an event. Regarding the return of irregular heart rhythms over 12 months, the reported figures — expressed as a probability estimate called a Kaplan-Meier rate (a statistical way of accounting for people who left the study early) — show that approximately 72.9% of main study participants and 71.8% of sub-study participants were free from any documented recurrence of their irregular rhythm. When looking only at episodes that caused symptoms, those figures rose to around 80.4% and 75.9% respectively. The reported data also shows several secondary (additional) measures. When a second ablation procedure was counted as a failure, freedom from recurrence was reported at 71.5% (main study) and 71.8% (sub-study). When participants who were taking certain heart-rhythm medications after their initial procedure were also counted as failures, the freedom-from-recurrence figures were lower — around 64.0% in the main study and 65.8% in the sub-study. These figures reflect how the results changed depending on the specific rules used to define "no recurrence." These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04435769 · results posted 8 February 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 109 people in total — 42 in the apixaban group and 67 in the warfarin group — and all participants completed the study. The trial was conducted in people with a type of irregular heartbeat called non-valvular atrial fibrillation (AF). It looked at two things: how participants scored on two established risk-scoring tools (one estimating stroke risk, called CHA₂DS₂-VASc, and one estimating bleeding risk, called HAS-BLED, both scored from 0 to 9 with higher numbers meaning higher risk), and how many outpatient clinic visits participants made over six months and what those visits cost. The reported data shows that at the start of the study, the average stroke-risk score was 4.6 for the apixaban group and 4.3 for the warfarin group. By the six-month mark, these had risen slightly to 5.0 and 4.9 respectively. For the bleeding-risk score, the starting averages were 2.7 (apixaban) and 2.5 (warfarin), rising to 3.1 and 2.8 at six months. Regarding clinic visits, the reported data shows that 55% of apixaban participants had no outpatient visits during the six months, compared with 44.4% of warfarin participants. The reported average cost of outpatient visits over six months was 258.8 Czech koruna (the local currency used in the trial) for the apixaban group and 414.3 Czech koruna for the warfarin group. No secondary outcome data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03650556 · results posted 27 April 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03650556) enrolled 224 participants, all placed in a single group. The trial was measuring two main things: how many participants experienced a serious adverse event (an unexpected, significant medical event) linked to the device or procedure within 7 days of the ablation, and how many participants remained free from returning episodes of irregular heart rhythms — specifically atrial fibrillation (AF), atrial flutter (AFL), or atrial tachycardia (AT) — over a follow-up period. A total of 187 participants completed the full study period of around 15 months. The reported data shows that 7 out of 224 participants experienced a device- or procedure-related serious adverse event within 7 days of the ablation procedure. For the main rhythm-related outcome, 114 participants were reported as being free from a return of AF, AFL, or AT episodes lasting longer than 30 seconds during the monitoring period after an initial "blanking" phase (a settling-in period where early recurrences were not counted as failures). For the secondary outcomes, 219 out of 223 participants who underwent the procedure were reported to have achieved the immediate procedural goal of blocking electrical signals in all pulmonary veins (the veins connected to the heart). The reported data also shows that 89 participants who were not taking anti-arrhythmic medications (drugs used to manage irregular heart rhythms) remained free from rhythm recurrences at 15 months, and 110 participants achieved 15-month success after a single procedure without needing a repeat. It is worth noting that the data as submitted does not include the total denominators for some secondary outcome calculations, so the full percentage figures cannot be confirmed from the reported numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02785991 · results posted 15 March 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,742 people who had been diagnosed with atrial fibrillation (an irregular heartbeat condition). Almost all of them — 1,741 out of 1,742 — completed the study. The trial was measuring how well a procedure called cryoablation (where cold energy is used to treat the heart tissue causing the irregular rhythm) prevented atrial fibrillation from coming back over 12 months, as well as how completely the procedure isolated certain areas of the heart, and how many unwanted events linked to the procedure were recorded. The reported data shows that 79% of participants had no recorded return of atrial fibrillation at the 12-month mark — meaning their heart rhythm was checked using devices such as ECG machines or heart monitors, and no episodes lasting 30 seconds or more were detected. For the secondary measurements, the reported data shows that in 1,726 out of the participants, the targeted areas of the heart (the pulmonary veins) were successfully electrically disconnected during the procedure. The reported data also shows that 120 adverse events (unwanted occurrences linked to the procedure) were recorded across the study group, though the data as reported does not break down the nature or severity of those individual events. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03040661 · results posted 11 January 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 70 people in total — 35 in each group. All 70 participants completed the study, with no dropouts reported. The trial was comparing two methods of stopping bleeding at the groin access site after a heart procedure called cardiac ablation: one method used a specific type of stitch (called a "figure of 8 suture") placed at the site, while the other used manual pressure applied by hand. The trial measured how long each method took to stop the bleeding, how long it took for patients to leave the procedure room after the ablation was finished, and what percentage of patients in each group experienced complications at the groin site. The reported data shows that the figure of 8 suture group had a recorded time of 0 minutes to achieve bleeding control (suggesting bleeding was stopped immediately at the time of the stitch), compared to 15 minutes for the manual pressure group. For the time from the end of the ablation procedure until leaving the procedure room, the figure of 8 suture group's reported average was 20 minutes, compared to 28 minutes for the manual pressure group. Regarding groin-area complications — which the trial defined as things like bleeding, bruising (haematoma), a specific type of blood vessel injury (pseudoaneurysm), needing extra pressure applied, or requiring a blood transfusion — the reported data shows 8.6% of participants in the figure of 8 suture group experienced such complications, compared to 34.2% in the manual pressure group. These figures are the numbers submitted by the trial sponsor and describe what was observed in this specific group of participants under the conditions of this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02879448 · results posted 11 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02879448) enrolled 934 people in the Amulet group and 944 people in the WATCHMAN group — a total of 1,878 participants. Both devices are small implants placed inside the heart to close off a small pouch (called the left atrial appendage) in people with an irregular heartbeat, with the aim of reducing the risk of blood clots travelling to the brain or other organs. The trial measured and compared the two devices across several outcomes, including procedure-related complications, deaths, major bleeding events, strokes, and how completely each device sealed the pouch. The reported data shows that for the main safety measure — a combined rate of procedure-related complications, death from any cause, or serious bleeding — 14.5% of Amulet participants and 14.7% of WATCHMAN participants reached that combined endpoint. For the main effectiveness measure — a combined rate of stroke caused by a clot or a clot travelling to another part of the body — the reported figure was 2.8% in both groups. For the measure of how completely the device sealed the pouch (assessed by ultrasound at around 45 days), 98.9% of Amulet participants and 96.8% of WATCHMAN participants were recorded as achieving a good seal. On the secondary measures, the combined rate of all stroke types, clot events, or cardiovascular/unexplained death was reported as 5.6% for Amulet and 7.7% for WATCHMAN, while the rate of serious bleeding alone was 11.6% for Amulet and 12.3% for WATCHMAN. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02690649 · results posted 28 October 2021

  According to the results reported on ClinicalTrials.gov, this trial involved 160 people in total, split evenly into two groups of 80. One group received health messaging (described as non-procedural), while the other group received no health messaging. The trial was looking at whether receiving health messages made a difference to how reliably participants took their medication, how often they logged into an online health portal, how much they knew about atrial fibrillation (an irregular heartbeat condition), and how many experienced serious health events during the study. The reported data shows that participants in the health messaging group took a recorded 93.08% of their allotted medication doses, compared with 89.52% in the no-messaging group. For patient portal logins — used as a measure of engagement with their own healthcare — the health messaging group logged in an average of 42.7 times, while the no-messaging group logged in an average of 15.9 times. On a knowledge quiz about atrial fibrillation scored from 0 (no knowledge) to 11 (high knowledge), the health messaging group scored an average of 7.31 and the no-messaging group scored 6.64. Regarding serious health events such as death, stroke, or major bleeding, the reported data shows 11 participants in the health messaging group and 6 in the no-messaging group experienced one or more of these events. No further detail about those events was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03347695 · results posted 18 October 2021

  According to the results reported on ClinicalTrials.gov, this trial looked at a new surgical procedure for people who had both a longstanding irregular heart rhythm (called atrial fibrillation, or AF) and a heart valve problem requiring mitral valve surgery. A total of 140 people took part — 20 in a smaller pilot (test-run) group and 120 in the main group. The trial measured three main things: how many patients no longer had AF after surgery, how long a key part of the operation (called cardiopulmonary bypass, where a machine temporarily takes over the heart and lungs) lasted, and how many patients experienced serious unwanted health events within 30 days of surgery. The reported data shows that, regarding freedom from AF (defined as no episode lasting more than 30 seconds, measured using a 7-day heart monitor at 6 and 12 months after surgery), all 20 pilot-group participants and 96–98 out of the main group participants were recorded as AF-free at the various measurement points. The reported average bypass machine time was 44.4 minutes for the pilot group and 52.5 minutes for the main group. For serious health events within 30 days, the reported data shows 0 events in the pilot group across all categories measured; in the main group, small numbers were recorded in some categories — for example, 2 participants experienced one type of event, and 1 participant each experienced certain other listed events — while several categories recorded 0 events in both groups. The reported data also includes measurements of the size of a chamber in the heart (the left atrium) taken by ultrasound before and after surgery. The reported figures show small changes in three dimensions of that chamber across both groups, though the data as submitted does not clearly separate "before" and "after" timepoints for these measurements, so the direction and size of any change cannot be precisely described from the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03114124 · results posted 1 September 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03114124) enrolled 30 people in total — 15 in each of two groups. One group was treated using a Bipolar Ablation Catheter and the other using a MIFI Ablation Catheter. Both are types of specialised medical devices used to deliver radiofrequency (heat) energy to a precise area of the heart. All 30 participants completed the study. The trial was measuring the time it took for each device to produce a specific heart response — either a "junctional rhythm" (a particular change in the heart's electrical activity) or "complete heart block" (when the heart's upper and lower chambers stop communicating electrically) — which were the signs the researchers used to judge whether the procedure had achieved its immediate goal. The reported data shows that, for the primary outcome — the difference in time between the two groups to reach that heart response from the start of the procedure — the Bipolar Ablation Catheter group recorded a value of 5 seconds, and the MIFI Ablation Catheter group recorded a value of 4 seconds. For the secondary outcome — the time from when the radiofrequency energy was first applied to when that same response occurred — the reported data shows 615 seconds for the Bipolar Ablation Catheter group and 525 seconds for the MIFI Ablation Catheter group. No further details about how these figures were calculated (for example, averages or ranges) were included in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03118518 · results posted 11 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03118518) enrolled 210 people with atrial fibrillation (an irregular heartbeat condition) — 108 were randomly assigned to receive a procedure called cryoballoon catheter ablation (where extreme cold is used to treat areas of the heart causing the irregular rhythm), and 102 were assigned to take antiarrhythmic drug therapy (medicines that aim to control heart rhythm). The trial was measuring how many people in each group were considered to have a "treatment success" at 12 months — meaning they had no return of the irregular rhythm detected, no further heart procedures, and no additional rhythm-control medicines (for the ablation group). The reported data shows that, among those who received the ablation procedure as planned, 73.7% were recorded as meeting the "treatment success" definition at 12 months. In the drug therapy group, 45.0% met the same definition. For a separate safety-related measurement in the ablation group only, the reported data shows that 1.92% of participants experienced one or more of a defined list of serious events (such as stroke, significant bleeding, or nerve injury) tracked over the study period. For quality-of-life scores, the reported data shows changes from the start of the study to 12 months in the ablation group only — a change of 33.3 points on one questionnaire (scored 0–100, where higher is better) and 0.04 points on a second questionnaire (scored 0–1, where higher is better); comparison figures for the drug group were not reported in the submitted data. The reported data also shows a secondary measure looking at healthcare use over 12 months: 69.9% of the ablation group had no cardiovascular-related hospital visits, emergency room visits, or unscheduled appointments, compared with 53.5% in the drug group. Separately, 97.1% of the ablation group had no cardioversion procedures (attempts to reset heart rhythm) recorded during the 12 months, compared with 92.4% in the drug group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02211456 · results posted 4 March 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02211456) enrolled 15 participants, and all 15 completed the study with no dropouts. The trial was looking at how the heart responded in the short term to two different ways of delivering electrical pacing: a standard approach called biventricular pacing (stimulating the right and left sides of the heart) compared with a newer approach called dual left ventricular pacing (stimulating two separate spots on the left side of the heart only). To measure the heart's response, the researchers tracked a value called "LV dP/dt max" — essentially a measure of how forcefully and quickly the heart's main pumping chamber contracts. The reported data shows that dual left ventricular pacing produced a 3.7% difference in that heart-contraction measurement compared with biventricular pacing. No other outcome measures appear to have been submitted to ClinicalTrials.gov for this trial, so further detail on any additional measurements was not reported. It is worth noting that this was a small, short-term study focused purely on an immediate physical measurement taken during a procedure — it was not designed to track how participants felt or what happened to their health over a longer period. The reported data shows only a single numerical result from 15 people, and no comparison group data (such as a placebo or control arm) was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01927367 · results posted 16 September 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 1,145 people with atrial fibrillation (an irregular heartbeat condition). Participants were split into two groups: 597 people received care supported by a computerised decision-support tool designed to guide doctors managing atrial fibrillation, and 548 people received usual care without that tool. The trial was primarily measuring how many people in each group ended up being admitted to hospital overnight for heart-related reasons, or visited an emergency department for symptoms linked to their atrial fibrillation. The reported data shows that, out of those who completed the trial, 118 participants in the decision-support tool group had a cardiovascular hospital admission or an atrial fibrillation-related emergency department visit, compared with 130 participants in the usual care group. Looking at emergency department visits on their own (a secondary measure), the reported data shows 78 people in the decision-support tool group had such a visit, compared with 96 in the usual care group. For several other secondary outcomes — including quality of life, costs, cost-effectiveness, and access to specialist care — the data was not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03263702 · results posted 21 April 2020

  According to the results reported on ClinicalTrials.gov, this trial enrolled 64 people in total — 38 in a "De Novo" group (people having their first ablation procedure for atrial fibrillation, an irregular heart rhythm) and 26 in a "Re-Do Ablation" group (people who had undergone a previous ablation). The trial was measuring several things related to the ablation procedure itself, including whether the irregular heart rhythm stopped during the procedure, and whether participants remained free from the return of abnormal heart rhythms in the months that followed. The reported data shows that during the procedure, the heart rhythm converted to a normal or different rhythm (called "termination") in 23 out of 38 participants in the De Novo group and 12 out of 26 in the Re-Do group. When it came to staying free from recurring abnormal rhythms without taking any rhythm-controlling medications, the numbers reported were 25 out of 35 completers in the De Novo group and 13 out of 22 in the Re-Do group. When the count was broadened to include people who were free from recurrences whether or not they used some rhythm-controlling medication, the figures were 25 (De Novo) and 17 (Re-Do). For the secondary measures, the reported data shows that after the procedure, abnormal rhythms could still be triggered by a stimulation test in 61% of De Novo cases and 46% of Re-Do cases. The average procedure time using radiofrequency energy was around 323 minutes for the De Novo group and 316 minutes for the Re-Do group, and the average time using X-ray imaging during the procedure was about 25.5 minutes and 24.1 minutes respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03370536 · results posted 10 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03370536) enrolled people with atrial fibrillation (AF), which is an irregular heartbeat condition. Only one participant took part in the study overall. The trial was set up to measure things like whether participants no longer experienced recurring episodes of AF after treatment, how many and how large the "drivers" of AF were (drivers being areas in the heart thought to be triggering the irregular rhythm), how those areas changed after a medication called ibutilide was given, how often AF stopped during the procedure, and how long the procedure took. The reported data shows that the single participant who was enrolled did not complete the study. Importantly, no numerical results were reported for any of the outcome measures — not for the primary outcome (freedom from recurring AF) nor for any of the secondary outcomes, including number of drivers, size of drivers, change in driver regions, AF termination rate, or procedure time. Because no measurement data was submitted for any of these outcomes, it is not possible to describe what the results showed. Given that only one person was enrolled and no outcome data was recorded or reported, the trial did not generate findings that can be meaningfully described or compared. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02415400 · results posted 7 February 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02415400) enrolled 4,614 participants in total, spread across four groups. Each group received a different combination of two blood-thinning or antiplatelet medicines: apixaban or a vitamin K antagonist (a type of blood thinner), each paired with either aspirin or a matched dummy tablet (placebo). The trial ran for six months and was measuring the rate of certain bleeding events, as well as rates of death, rehospitalisation, and serious cardiovascular events such as stroke or heart attack. The reported data shows the following for the main (primary) outcomes, expressed as estimated event rates per year. For the comparison of the two blood thinners: the apixaban group had a reported bleeding event rate of about 24.7% per year, while the vitamin K antagonist group had a reported rate of about 35.8% per year. For the comparison of aspirin versus placebo: the aspirin group had a reported bleeding event rate of about 40.5% per year, compared with about 21.0% per year in the placebo group. These figures represent the percentage of participants per year who experienced a significant or clinically notable bleeding episode — they are not simple "one in X people" counts, but a statistical way of accounting for different follow-up times. The reported data for the secondary outcomes shows: the combined rate of death or rehospitalisation from any cause was reported as approximately 57.2% per year for apixaban versus 69.2% per year for the vitamin K antagonist, and approximately 65.7% per year for aspirin versus 60.6% per year for placebo. The rate of serious cardiovascular events (death, stroke, heart attack, or related events) was reported as approximately 15.9% per year for apixaban versus 17.2% per year for the vitamin K antagonist. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02878213 · results posted 18 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 39 participants, with 36 completing the study and 3 not completing it. The trial was testing a medical imaging system called the D700 (KODEX-EPD) system, which is used during a heart procedure to treat an irregular heartbeat. Specifically, the trial was measuring how well the system could predict "gaps" — meaning spots where the procedure may not have been fully completed — compared to what was actually found when patients came back for a second check-up procedure one month later. All participants had the same heart procedure (called pulmonary vein isolation) and the doctors performing the initial procedure were not shown the system's gap predictions at the time, so their decisions were not influenced by it. The reported data shows that at the initial procedure, the system assessed 1,549 individual points around the heart, and recorded 231 readings overall. The system predicted 48 gaps during the initial procedure. When patients returned one month later for their check-up procedure, 13 actual gaps were found. Looking at results at the individual patient level, the reported data shows that out of 36 patients who completed the study, 18 were assessed in a particular category, with 9 falling into one sub-group and 9 into another, and 0 in a further sub-group — however, the labels describing exactly what each of these patient sub-groups represent were not included in the data as reported, so a fuller explanation of these numbers cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02407249 · results posted 16 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 73 people in total, of whom 60 received the treatment and 47 completed the study. The trial was looking at a procedure called atrial fibrillation (AF) ablation — a technique aimed at disrupting the electrical signals in the heart that cause an irregular heartbeat. The study tracked both how well the procedure went in the short term (during and just after the procedure) and whether participants remained free from their irregular heartbeat returning over the following 12 months. The reported data shows that out of the group who were analysed, 53 participants had what the trial called "acute success," meaning the targeted areas in the heart were successfully treated during the procedure itself. When it came to 12-month effectiveness — defined as having no return of the irregular heartbeat in the year after the procedure (not counting the first three months, which were set aside as a settling-in period) — 34 participants met that measure. Regarding serious unwanted events, the reported data shows that 56 participants were free from serious adverse events (unexpected harmful occurrences) in the first 7 days after the procedure, 51 were free from them at 6 months, and 45 remained free from them at the 12-month mark. The trial did not report what happened to participants who did not complete the study beyond noting that 26 did not finish. It is worth noting that the numbers reported relate to a specific group of people under specific trial conditions, and the data describes what was measured and counted — not a broader conclusion about the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00911508 · results posted 26 August 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT00911508) enrolled 2,204 people with atrial fibrillation (an irregular heartbeat condition). Participants were split into two groups: 1,108 people received a procedure called left atrial ablation (where heart tissue is targeted to try to correct the irregular rhythm), and 1,096 people received standard medication-based treatment to either control their heart rate or rhythm. The trial was measuring serious health events over time, including death, disabling stroke, serious bleeding, and cardiac arrest. The reported data shows that for the main outcome — the number of people who experienced at least one of those serious events — 89 participants in the ablation group and 101 participants in the medication group met that combined measure. For individual secondary outcomes, the reported data shows: all-cause death occurred in 58 people in the ablation group and 67 in the medication group; death or a hospital stay for a heart-related reason was recorded in 573 versus 637 people respectively; death, disabling stroke, or hospitalisation for heart failure or a heart attack was recorded in 170 versus 189 people; death specifically from a heart-related cause occurred in 22 versus 23 people; and the combination of heart-related death or disabling stroke was recorded in 24 versus 27 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03354663 · results posted 20 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 156 people and looked at a catheter ablation device called TactiCath SE, which is used to treat an irregular heart rhythm condition. The trial was measuring two main things: how often serious medical complications occurred within 7 days of the procedure, and how often the procedure achieved its intended technical goal — specifically, whether the electrical pathways into all four pulmonary veins (blood vessels connected to the heart) were successfully blocked. The reported data shows that out of 151 people who went on to have the procedure, 148 had what was recorded as a successful procedure, meaning the electrical blocking was confirmed in all pulmonary veins. On the safety side, 7 participants out of the safety group experienced a serious adverse event — meaning a significant medical complication — within 7 days of the procedure. The reported data also shows that, looking out to 30 days and then to 1 year after the procedure, 5 participants experienced a serious adverse event directly related to the procedure or device. An additional figure of 23 participants was also listed in that same category, though the reported data does not clearly separate what each of those two numbers represents, so a precise breakdown cannot be confirmed from the available information. The average power delivered by the device during cases was reported as 29.0 watts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02684981 · results posted 24 July 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02684981) enrolled a total of 9,465 participants across three groups: Cohort A (4,100 people already on a blood-thinning medication called dabigatran/Pradaxa®), Cohort B–Pradaxa® (3,179 people newly starting dabigatran), and Cohort B–VKA (2,186 people newly starting an older type of blood thinner called a vitamin K antagonist, or VKA). The trial was measuring how satisfied and how comfortable patients felt with their blood-thinning treatment, using a patient questionnaire called the PACT-Q2. This questionnaire produces scores from 0 to 100, where higher numbers represent a better experience. The trial also recorded information about each participant's stroke risk and bleeding risk using two standard scoring tools. The reported data shows that for Cohort A (people already on dabigatran), the middle value (median) change in "convenience" scores rose by about 19 points early in the study and about 23 points by the later stage, compared to where they started. Their "satisfaction" scores rose by roughly 18 points early on and about 21 points later. For Cohort B, the reported data shows that at both the early and later stages, the Pradaxa® group's convenience scores (around 83 and 87 out of 100) were higher than those in the VKA group (around 50 and 60 out of 100). Similarly, satisfaction scores for the Pradaxa® group (around 68 and 71 out of 100) were reported as higher than those in the VKA group (around 50 out of 100 at both points). Regarding stroke risk, roughly 88–91% of participants across all groups were classified as high risk. For bleeding risk, the proportions varied more noticeably between groups, with Cohort A having a higher percentage classified as high bleeding risk (about 59%) compared to Cohort B groups (about 29–31%). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02703454 · results posted 21 May 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02703454) enrolled 51 people in total — 24 in a group receiving a procedure called FIRM-only ablation and 27 in a group receiving conventional ablation (a different technique used to treat an irregular heart rhythm called atrial fibrillation, or AF). The trial's main goal was to count how many participants in each group had no return of their irregular heart rhythm (AF or a related rhythm problem) during the period from 3 to 12 months after their procedure, based on monitoring with standard heart-rhythm recording equipment. The reported data shows that, of the participants who could be assessed for the main outcome, 5 out of those in the FIRM-only group and 8 out of those in the conventional group had no recorded return of their irregular heart rhythm during that follow-up window. It is worth noting that a notable number of participants did not complete the study — 11 in the FIRM-only group and 16 in the conventional group — so the numbers assessed at the end were smaller than those who started. For the secondary outcome, the reported data shows that 12 participants in the FIRM-only group and 14 participants in the conventional group had no serious unwanted events recorded that were considered related to their procedure within one year. It should also be noted that the trial's completion numbers were relatively small (13 completed in the FIRM-only group and 11 in the conventional group), which the data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02072434 · results posted 13 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02072434) enrolled 2,199 participants in total — 1,095 in the edoxaban group and 1,104 in the warfarin group. The trial was measuring two main things: firstly, how many participants experienced a serious cardiovascular event (such as stroke, a clot travelling to another part of the body, heart attack, or death from a heart or blood vessel cause); and secondly, how many participants experienced significant bleeding. A secondary measurement combined both the cardiovascular events and major bleeding together into a single figure. The reported data shows that for the first primary measure — serious cardiovascular events — 0.5% of participants in the edoxaban group and 1.0% of participants in the warfarin group recorded this outcome. For the second primary measure — significant bleeding — 1.5% of participants in the edoxaban group and 1.0% of participants in the warfarin group recorded this outcome. For the secondary combined measure of cardiovascular events and major bleeding together, the reported figures were 0.7% for the edoxaban group and 1.4% for the warfarin group. It is worth noting that these percentages are relatively small numbers, and the trial followed participants only up to the end of the study follow-up period. The reported data shows the proportions of people who experienced these events during that time, but does not tell us why any differences between the groups occurred. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01558635 · results posted 1 March 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 17 adults who all received a surgical heart procedure using a device called the Cardioblate CryoFlex Surgical Ablation System. The participants had a condition called longstanding persistent atrial fibrillation (AF) — an irregular heartbeat that has continued for a long time. The trial was measuring two main things: how many people had no signs of AF at 12 months without taking certain heart-rhythm medications, and how many people experienced serious unwanted medical events within 30 days of the procedure. Not all 17 participants made it to the end of the study — 11 completed the full 12 months of follow-up. The reported data shows that at the 12-month mark, 5 out of the 17 participants met the main goal of being free from AF without certain medications and without needing a repeat ablation procedure. For the safety measurement, the reported data shows that 1 participant experienced one of the listed serious medical events (a peripheral arterial embolism, meaning a blood clot blocking an artery in a limb), while no participants experienced the other listed serious events such as stroke, heart attack, or death. For the secondary outcomes — which looked at AF freedom regardless of whether someone was on heart-rhythm medication — the reported numbers were 5 participants free from AF at 3 months, 4 at 6 months, and 3 at 12 months. The reported data also shows the average proportion of time participants spent in AF per day was 3.0% at 3 months, 1.3% at 6 months, and 2.4% at 12 months, compared to the trial's goal of less than 0.5% per day. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03140631 · results posted 23 October 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT03140631) enrolled 150 people in total — 73 in the control group and 77 in a group that received a medication called protamine. All 150 participants completed the study with no drop-outs recorded. The trial was looking at two main things: how long it took patients to get up and walk after a procedure, and how many people had complications at the site where a needle or tube had been inserted into a blood vessel in the 90 days following the procedure. The reported data shows that, on average, patients in the control group took 480 minutes (8 hours) to get up and walk after the procedure, while patients in the protamine group took 316 minutes (just over 5 hours). For the second measurement — complications at the access site, such as bruising, abnormal connections between blood vessels, or the need for a follow-up procedure — the reported data shows that 4 out of 73 people in the control group and 6 out of 77 people in the protamine group experienced at least one of these complications. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02164864 · results posted 31 July 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02164864) compared three blood-thinning treatments in people with a heart condition that raises the risk of blood clots: two different doses of dabigatran etexilate (110 mg and 150 mg) and a well-established medicine called warfarin. A total of 2,725 people were enrolled across the three groups — 981 in the 110 mg dabigatran group, 763 in the 150 mg dabigatran group, and 981 in the warfarin group. The main thing the trial was tracking was the time until a participant experienced their first serious bleeding event or a clinically important (but not major) bleeding event. The reported data shows that, for the primary measure of bleeding, 151 people in the dabigatran 110 mg group, 154 people in the dabigatran 150 mg group, and 264 people in the warfarin group experienced one of these bleeding events. The trial also looked at a number of secondary measures. For deaths from any cause, the reported numbers were 55 in the dabigatran 110 mg group, 30 in the dabigatran 150 mg group, and 48 in the warfarin group. For heart attacks, 44 were reported in the dabigatran 110 mg group, 26 in the dabigatran 150 mg group, and 29 in the warfarin group. Smaller numbers of cardiovascular deaths, non-cardiovascular deaths, and deaths where the cause could not be determined were also recorded across all three groups. The reported data also includes a separate sub-group called "Warfarin (Excluding Elder Patients Outside USA)" for some analyses, though the reasons for this grouping are not explained in detail in the submitted results. It is worth noting that the numbers above simply count how many participants experienced each event — they do not on their own tell us whether any difference between groups is meaningful without further analysis, which was not included in this summary data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01687166 · results posted 18 June 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT01687166) looked at a heart procedure catheter called the Blazer Open-Irrigated (OI) Ablation Catheter, which is used to treat an irregular heart rhythm called atrial fibrillation. The trial enrolled a total of 398 people across four groups: 167 people used the Blazer OI catheter (the main study group), 172 people were in the comparison (control) group, and a further 59 people were in smaller "roll-in" practice groups. The trial was measuring two main things: whether patients had no serious procedure-related complications, and whether patients remained free from a return of their irregular heart rhythm over 12 months after the procedure. The reported data shows the following numbers for the two main groups. For the complication-free outcome, 140 out of 167 participants in the Blazer OI group and 148 out of 172 participants in the control group were reported as having no serious procedure-related complications. For the longer-term success outcome — meaning no return of the irregular heart rhythm between 91 days and 12 months after the procedure — 102 out of 167 participants in the Blazer OI group and 108 out of 172 participants in the control group were reported as meeting this measure. For the secondary outcome of immediate procedural success (successfully isolating the targeted areas of the heart during the procedure itself), the reported data shows 155 out of 167 in the Blazer OI group and 163 out of 172 in the control group achieved this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01830543 · results posted 31 July 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01830543) enrolled 2,124 participants across three groups: one group took rivaroxaban 15 mg once daily (709 people), a second group took rivaroxaban at a lower dose of 2.5 mg twice daily that later stepped up to 15 mg once daily (709 people), and a third group took a Vitamin K Antagonist — a standard blood-thinning medicine — (706 people). The trial was measuring rates of bleeding events and certain heart-related events across these three treatment approaches in people with a specific heart condition. The reported data shows that for the main thing being measured — any clinically significant bleeding (a combined figure covering serious bleeding, moderate bleeding, and bleeding needing medical attention) — 15.7% of participants in the rivaroxaban 15 mg group, 16.6% in the lower-to-higher rivaroxaban dose group, and 24.0% in the Vitamin K Antagonist group experienced such an event. For the secondary measures, the reported data shows that serious bleeding (called "TIMI major bleeding") was recorded in 2.0%, 1.7%, and 2.9% of participants in the three groups respectively. Bleeding events that required medical attention (but were not classified as serious or moderate) were reported in 13.4%, 14.4%, and 19.9% of participants. For a combined measure of major heart-related events — cardiovascular death, heart attack, and stroke together — the reported figures were 5.9%, 5.1%, and 5.2% across the three groups. Cardiovascular death alone was reported in 2.2%, 2.0%, and 1.6% of participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02986282 · results posted 18 July 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 115 participants in a single group — meaning everyone received the same treatment with no comparison group. The trial was measuring something called the Ankle-Brachial Index, or ABI, which is a simple ratio comparing blood pressure measured at the ankle to blood pressure measured at the arm. It is used as an indicator of blood flow in the legs. The trial looked at ABI readings taken before and after a procedure called electrical cardioversion (a procedure that uses a controlled electric shock to try to restore a normal heart rhythm), and compared two different ways of measuring ABI: a Doppler method (which uses sound waves to detect blood flow) and an oscillometric method (which uses pressure cuffs, similar to a standard blood pressure machine). Of the 115 who started, 99 completed the study and 16 did not. The reported data shows the following ABI measurements. For the primary outcome — comparing the two measurement methods before the cardioversion procedure — the reported median ABI values were 1.21 and 1.215 (for one method) and 1.14 and 1.18 (for the other method). A ratio around 1.0–1.4 is generally considered within a typical range, though interpreting what these numbers mean clinically is a matter for a medical professional. For the secondary outcome — comparing ABI before and after the cardioversion procedure using the Doppler method — the reported median values were 1.14 (before) and 1.18 (after). The data does not include further detail on the statistical comparison between these figures, so no additional numbers can be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01558128 · results posted 23 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled only **1 participant** in a single group who received amiodarone (a heart rhythm medication) combined with cardioversion (a procedure used to reset the heart's rhythm). The trial was measuring changes in the participant's heart rhythm over the course of the study. The reported data shows that 1 participant started the study and 1 participant completed it, with no one leaving early. For the primary outcome — tracking any change in heart rhythm from the start of the study — the reported result records a value of 1 participant. Beyond this count, no further numerical detail about the nature of the rhythm change was reported in the submitted results. Any additional outcome measures beyond this single primary measure were not reported in the data available on ClinicalTrials.gov. It is worth noting that a trial of just one person is extremely small, and the submitted data is very limited in detail, so there is very little information to draw broader meaning from these results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00461734 · results posted 25 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 120 participants in each of two groups — one group had their pacemaker lead placed at the tip of the right ventricle (called the "RV Apex"), and the other had it placed higher up on the heart's inner wall (called the "RV High Septum"). The trial was looking at two main things over two years: how the pumping strength of the heart's main chamber changed over time, and how often participants experienced fast, irregular heart rhythms in the upper chambers of the heart (known as atrial tachyarrhythmia). Not all participants completed the full two years — around 62 finished in the RV Apex group and 60 in the RV High Septum group. The reported data shows that, for the primary measure — the change in the heart's pumping strength (measured as "left ventricular ejection fraction," which is simply the percentage of blood the heart pumps out with each beat) — both groups showed a small decline over two years. In the broader group analysis, the RV Apex group showed an average change of −2.29 percentage points and the RV High Septum group showed −3.43 percentage points. In the analysis limited to those who completed the study as planned, the figures were −2.04 and −3.60 percentage points respectively. For the secondary measure of irregular fast heart rhythms, the reported data shows varying results across the different analyses, ranging from approximately 6.66 to 63.83 minutes per day depending on the group and the analysis method used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

  View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

• NCT01008722 · results posted 8 February 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people with atrial fibrillation (an irregular heartbeat condition). Participants were divided into two groups: 36 people received a procedure called "FIRM-Guided" ablation (a technique that uses detailed mapping of the heart to guide treatment), and 71 people received a "Conventional" ablation procedure. All 107 participants completed the study. The trial was measuring two main things: how many people remained free of atrial fibrillation after their procedure, and how many people's atrial fibrillation stopped or slowed down during the procedure itself. The reported data shows that, for the primary outcome — remaining free of atrial fibrillation after treatment — 28 out of 36 people in the FIRM-Guided group and 31 out of 71 people in the Conventional group met this measure. For the secondary outcome — whether the atrial fibrillation stopped or noticeably slowed down during the ablation procedure — the reported data shows this occurred in 31 out of 36 people in the FIRM-Guided group and 13 out of 71 people in the Conventional group. These figures describe only what was counted and recorded in this specific trial; they do not tell us everything about how these procedures may perform more broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02222818 · results posted 6 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 66 people in total — 33 in each group. It used a "crossover" design, meaning participants tried both settings being compared: one called CAFR and one called CAFRPlus. These appear to be two different programming settings for a cardiac resynchronisation therapy (CRT) device — a type of heart pacemaker. The trial was measuring how often the device delivered what it counted as an "effective" pacing beat during a heart rhythm problem called atrial fibrillation (AF), where the upper chambers of the heart beat irregularly. Three participants from one group did not complete the first period of the trial, though no reason is specified in the reported data. The reported data shows that when the CAFR setting was active, the device delivered effective pacing beats approximately 80.8% of the time during AF. When the CAFRPlus setting was active, that figure was reported as approximately 87.8%. The primary goal of the trial was to assess whether CAFRPlus was "non-inferior" to CAFR — that is, whether it performed no worse — and the secondary goal was to assess whether CAFRPlus actually performed better (a "superiority" test). Both goals used the same two numbers. No additional detail about how these tests turned out statistically was included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01965899 · results posted 23 September 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 151 people who had a small heart-monitoring device called the Reveal LINQ inserted under their skin. Of these, 145 people completed the study. The trial was measuring how well the device transmitted data wirelessly to a home monitor, how clearly it picked up the heart's electrical signal (called the R-wave), and how accurately it detected an irregular heart rhythm known as atrial fibrillation (where the heart beats in an unsteady, disorganised way). The reported data shows that within the first 30 days after the device was inserted, 73.1% of the automatic wireless transmissions from the device were successful. For signal quality, the average R-wave strength was measured at 543.5 μV (microvolts, a unit of electrical signal size) at the time of insertion, and 599.4 μV at the one-month check. Around 97.3% of patients at insertion and 96.6% at one month had a signal strength at or above the 200 μV level the study was looking for. When comparing the device's ability to detect atrial fibrillation against a standard Holter monitor (a portable heart-recording device worn for a period of time), the reported data shows a sensitivity — meaning how often it correctly spotted an irregular rhythm when one was present — of 97.4%, and a specificity — meaning how often it correctly identified a normal rhythm as normal — of 97.0%. Regarding reported adverse events (unwanted medical occurrences tracked during the study), the data lists 9 procedure-related events, 45 device-related events, and 1 event each in two further categories, though the specific breakdown of what those categories represent was not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00958165 · results posted 27 July 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people, all of whom were in a single group receiving a treatment called EAS-AC for paroxysmal atrial fibrillation (PAF) — a condition where the heart beats irregularly in episodes that come and go. Of the 81 who started, 72 received the treatment and 67 completed the trial. The study was measuring whether, after an initial settling-in period, participants went through a full 12-month follow-up without any recurrence of their irregular heart episodes. The reported data shows that out of the participants assessed, 42 were recorded as having no recurrence of atrial fibrillation during the 12-month follow-up period after the initial blanking period (a short window at the start of the study where episodes are not counted, as is standard in this type of research). The results do not report the exact number of participants included in this final count, and no additional outcome measures beyond this single primary measure were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00971204 · results posted 27 July 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people, all of whom were in a single group receiving treatment with a device referred to in the data as EAS-AC (also called HeartLight in the outcomes section). Of those 100 people who started the study, 86 went on to receive the treatment, 76 completed the trial, and 24 did not complete it. The trial was measuring whether the treatment could stop an irregular heart rhythm condition — atrial fibrillation — from coming back over a 12-month period. The reported data shows that the main (primary) thing being measured was whether participants remained free from episodes of atrial fibrillation — specifically, episodes lasting one minute or longer — during the 12 months following an initial 90-day settling-in window (called a "blanking period"). According to the results reported on ClinicalTrials.gov, 50 participants out of the 86 who were treated met this measure, meaning they did not experience a return of symptomatic atrial fibrillation during that 12-month window. No secondary outcome measure results were included in the data provided, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02043808 · results posted 3 July 2015

  According to the results reported on ClinicalTrials.gov, this study enrolled 12,793 people in each group — one group taking dabigatran and one taking warfarin — giving a total of 25,586 participants. All participants had a heart rhythm condition called non-valvular atrial fibrillation (an irregular heartbeat not caused by a heart valve problem). The trial was an observational study, meaning it looked at real-world records rather than randomly assigning people to treatments. It was measuring how often strokes and serious bleeding events occurred in each group, expressed as the number of events per 1,000 people per year. The reported data shows the following event rates (per 1,000 people per year). For the two primary outcomes: overall stroke (both types combined) was reported at 9.15 in the dabigatran group and 13.19 in the warfarin group; major bleeding was reported at 30.84 in the dabigatran group and 37.04 in the warfarin group. For the secondary outcomes, ischemic stroke (caused by a blockage) was reported at 8.48 versus 10.69; hemorrhagic stroke (caused by bleeding in the brain) was reported at 0.77 versus 2.50; major bleeding inside the skull was reported at 2.69 versus 5.65; and major bleeding outside the skull was reported at 28.13 versus 31.30 — all figures with dabigatran listed first and warfarin second. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01857622 · results posted 26 January 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01857622) enrolled a total of 93 participants across three groups: 50 people in the "SRI 15mg" group, 22 in the "Normal/MiRI Low-dose" group, and 21 in the "Normal/MiRI High-dose" group. The trial was measuring how often bleeding events occurred across these groups. Of those who started, 39, 21, and 19 participants respectively completed the study. The main (primary) outcome the trial measured was the proportion of participants in each group who experienced a bleeding event — this included serious bleeds, bleeds considered clinically important but not major, and minor bleeds, all reviewed and confirmed by an independent panel. The reported data shows that 20.0% of people in the SRI 15mg group had a bleeding event, compared with 22.7% in the Normal/MiRI Low-dose group and 23.8% in the Normal/MiRI High-dose group. No secondary outcome measures were included in the data submitted to ClinicalTrials.gov, so those figures are not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01534962 · results posted 19 August 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 241 people across four groups to study a medicine called ranolazine in people with a heart rhythm condition called atrial fibrillation (AF — an irregular heartbeat). Participants had recently had their heart rhythm reset (a procedure called cardioversion) and were then given one of three different doses of ranolazine or a dummy pill (placebo) to compare how long it took before their irregular heartbeat returned. Not all participants finished the study: 30 of 67, 34 of 60, 34 of 58, and 24 of 56 completed it in the low-dose, intermediate-dose, high-dose, and placebo groups respectively. The reported data shows that the main thing being measured was the number of days from the start of the trial until the first return of irregular heartbeat, detected by a heart tracing (ECG). For the low-dose ranolazine group, this figure was reported as 51 days; for the high-dose group, 117 days; and for the placebo group, 58 days. The intermediate-dose group's figure was not reported for this measure. When looking at how many participants had a return of their irregular heartbeat at all, the reported numbers were: 37 out of 67 in the low-dose group, 25 out of 60 in the intermediate-dose group, 23 out of 58 in the high-dose group, and 31 out of 56 in the placebo group. The reported data also includes a number of secondary measures. For a stricter definition of recurrence — where the irregular heartbeat had to be confirmed by a second heart tracing at least one hour later — the number of participants affected was 31 (low dose), 19 (intermediate dose), 16 (high dose), and 24 (placebo). The time-to-recurrence figure under this stricter definition was only reported for the low-dose group (73 days); it was not reported for the other three groups. A further analysis looked only at people who were still in normal rhythm 48 hours after their cardioversion: reported time-to-recurrence figures were 56 days (low dose), not reported (intermediate dose), 117 days (high dose), and 78 days (placebo). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01721837 · results posted 31 July 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,120 participants, all of whom completed the study with no drop-outs recorded. The trial was measuring kidney function in patients, specifically looking at how well the kidneys filter waste from the blood. This was assessed using a calculation called creatinine clearance — a way of estimating how efficiently the kidneys are working, based on a person's age, sex, body weight, and the level of a waste product called creatinine in the blood. The reported data shows that the average creatinine clearance across all 2,120 participants was 55.2 ml/min (millilitres per minute — the volume of blood the kidneys are estimated to filter each minute). This figure was calculated using a standard medical formula known as the Cockcroft-Gault formula. No secondary outcome measures were included in the submitted results data. It is worth noting that only this single measurement was reported, and no comparison group or before-and-after data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01036724 · results posted 21 July 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people in total — 52 in the Carto 3 group and 55 in the NavX group. The trial was comparing two different mapping systems used to guide a heart procedure called radiofrequency ablation, which is used to treat a type of irregular heartbeat known as paroxysmal atrial fibrillation. The main thing being measured was how long patients were exposed to X-ray imaging (called fluoroscopy) during the procedure, and a secondary measure was how long the overall procedure took. By the end of the study, 46 people in the Carto 3 group and 47 in the NavX group had completed the trial. The reported data shows that, for X-ray exposure time, the Carto 3 group had an average of 31.0 minutes compared to 37.5 minutes in the NavX group. For total procedure time, the reported data shows the Carto 3 group averaged 160.5 minutes, while the NavX group averaged 147.0 minutes. These are the numbers as submitted; the trial did not report additional detail about individual variation within each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00559988 · results posted 23 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 2,718 people with implanted heart devices (pacemakers or similar) who also had a heart rhythm condition called atrial fibrillation — an irregular heartbeat that can raise the risk of stroke. Participants were split into two groups: 1,357 people had their blood-thinning medication (anticoagulation) guided by a remote home monitoring system that could detect irregular heart rhythms early, while 1,361 people had their blood-thinning medication managed in the usual way by their doctor. The trial was measuring whether one approach led to fewer strokes, clot-related events, or serious bleeds over time. The reported data shows that the main (primary) outcome tracked the percentage of people in each group who remained free from stroke, a clot travelling through the body (systemic embolism), or a major bleed. At various points over the follow-up period, the reported figures for the home monitoring group and the doctor-directed group were very close to each other — for example, at one point 92.3% versus 92.0%, and at another point 86.8% versus 87.9%. For the secondary outcomes, deaths from any cause numbered 147 in the home monitoring group and 140 in the doctor-directed group. Strokes caused by a clot numbered 22 versus 28, and strokes caused by bleeding numbered 3 versus 3. Major bleeding events were recorded in 46 people in the home monitoring group and 34 in the doctor-directed group. The average daily burden of irregular heart rhythm was reported as 1.3% versus 1.2% across the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00787800 · results posted 11 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people in total — 50 in a group receiving a dual-chamber implantable cardioverter-defibrillator (ICD, a small device implanted in the chest that can deliver an electric shock to correct dangerous heart rhythms) and 50 in a group receiving a single-chamber ICD. Of those, 47 and 43 participants respectively completed the study. The trial was measuring whether there were differences between the two device types in the number of people who received an "inappropriate shock" — meaning a shock delivered when the heart was not actually in a dangerous rhythm — as well as a range of other outcomes including abnormal heart rhythm episodes and procedure costs. The reported data shows that for the primary outcome, 1 participant in each group received an inappropriate shock. For the secondary outcomes, the dual-chamber group recorded 37 episodes of rapid abnormal heart rhythms originating in the upper chambers of the heart (lasting more than 5 minutes), compared with 0 in the single-chamber group. Twelve participants in the dual-chamber group were newly found to have these upper-chamber rhythm disturbances, versus none in the single-chamber group. The number of "appropriate shocks" (delivered during a genuinely dangerous heart rhythm) was 31 in the dual-chamber group and 1 in the single-chamber group. The reported average cost of the implantation procedure was USD $16,579 for the dual-chamber device and USD $14,249 for the single-chamber device. The proportion of time participants spent in abnormal upper-chamber rhythms was reported as 0.02% for the dual-chamber group and 0% for the single-chamber group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00926783 · results posted 3 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 83 people with atrial fibrillation (an irregular heartbeat condition). Participants were divided into two groups: 42 received "targeted CFAE ablation" and 41 received "generalized CFAE ablation." Both approaches are types of heart procedure that use radiofrequency (heat) energy to treat areas of abnormal electrical activity in the heart. The trial was mainly measuring how many people had no return of irregular heartbeat rhythms over the following year, as well as how long the procedures took. The reported data shows that, for the primary outcome of being free from irregular heart rhythms between roughly three months and one year after the procedure, 10 people in the targeted group and 18 people in the generalised group met this measure, while 29 in the targeted group and 20 in the generalised group did not. For the amount of time radiofrequency energy was delivered during the procedure, the reported data shows an average of 23.2 minutes in the targeted group compared to 37.8 minutes in the generalised group. Total procedure duration was reported as an average of 220.6 minutes for the targeted group and 226.1 minutes for the generalised group. The reported data also shows that 11 participants in the targeted group and 14 in the generalised group had their irregular heartbeat stop or become more regular during the procedure itself. For the secondary outcomes, the total time under X-ray (fluoroscopy) during the procedure was reported as an average of 57.4 minutes in the targeted group and 60.1 minutes in the generalised group. A measure of the electrical activity pattern in the heart (called atrial fibrillation cycle length) changed by an average of 23.3 milliseconds in the targeted group and 25.4 milliseconds in the generalised group from the start to the end of the procedure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00808067 · results posted 8 April 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT00808067) enrolled a total of 5,883 people — 2,927 in the dabigatran 110 mg group and 2,956 in the dabigatran 150 mg group. Of those, around 2,446 and 2,438 respectively completed the study. The trial was measuring how often serious bleeding occurred in people taking one of two doses of dabigatran, and also tracking several other events including stroke, blood clots travelling to organs or the lungs (embolism), heart attacks, and deep vein thrombosis (a blood clot in a leg vein). The reported data shows that for the primary outcome — serious (major) bleeding — the annualised rate (meaning the estimated percentage of participants experiencing the event per year) was 2.79% for the 110 mg group and 3.59% for the 150 mg group. For the secondary outcomes, the reported annualised rates were: stroke at 1.39% (110 mg) and 1.26% (150 mg); blood clots travelling to organs other than the brain at 0.25% and 0.23%; pulmonary embolism (a clot in the lungs) at 0.10% and 0.12%; heart attack at 0.72% and 0.66%; and deep vein thrombosis at 0.06% and 0.11%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00744874 · results posted 18 January 2013

  According to the results reported on ClinicalTrials.gov, 55 people with atrial fibrillation (an irregular heartbeat condition) took part in this trial, with 51 completing it and 4 not completing it. All participants underwent a heart procedure called pulmonary vein ablation, which uses a special catheter (a thin tube guided into the heart) to electrically isolate the pulmonary veins — the areas thought to trigger the irregular heartbeat. The trial measured how well the procedure isolated those veins immediately afterwards, how many participants were free of significant irregular heartbeat episodes at six months (while off certain heart medications), and how many experienced serious procedure- or device-related events. The reported data shows that, immediately after the procedure, 53 out of 55 participants had successful isolation of all pulmonary veins. For the six-month "chronic effectiveness" measure — which required participants to have no significant atrial fibrillation episodes recorded on a seven-day heart monitor, no symptoms after a three-month settling-in period, and to be off specific heart rhythm medications — 10 out of the participants met all those criteria. Regarding serious events considered related to the procedure or device, 2 participants experienced such an event within the first seven days after the procedure, and 0 participants experienced such an event between seven days and six months. The reported data also shows changes in two questionnaire scores over the study period. On a symptom severity scale (where 5 means no symptoms and 25 means most severe), the average score across participants was reported as 3.4 at the start and 2.7 at six months. On a general quality-of-life survey (where higher scores out of 100 suggest better self-reported health), the physical health summary score was reported as 46.4 at the start and 51.8 at six months, and the mental health summary score was reported as 46.8 at the start and 51.6 at six months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01151137 · results posted 26 October 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT01151137) enrolled 3,236 people in total — 1,617 in the placebo group and 1,619 in the dronedarone group. The trial was measuring two main things: first, how many participants experienced a serious heart or blood vessel event (such as stroke, heart attack, a clot travelling through the body, or death from a heart-related cause); and second, how many participants had an unplanned hospital visit for a heart or blood vessel reason, or died from any cause. Both groups were followed over time and the results were reviewed by an independent committee who did not know which treatment each person had received. The reported data shows that, for the first main outcome, 19 people in the placebo group and 43 people in the dronedarone group experienced one of those serious events. For the second main outcome, 67 people in the placebo group and 127 people in the dronedarone group had an unplanned cardiovascular hospital visit or died. Looking at deaths specifically, the reported data shows 13 deaths in the placebo group and 25 in the dronedarone group overall; of those, 10 and 21 respectively were classified as heart-related deaths, and 4 and 13 were classified as other (non-cardiovascular) deaths. The trial also tracked how these events built up over time using a standard statistical method (which estimates the running proportion of participants who had experienced an event at each point in time), and those figures were also higher in the dronedarone group at most time points reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00927862 · results posted 25 September 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00927862) involved two broad groups of people starting the blood-thinning medication warfarin. One group of 504 people had their warfarin starting dose calculated using pharmacogenetic (PG) dosing algorithms — meaning the dose was worked out using information about a person's genes alongside other factors. These participants were compared with a parallel/historical control group of 1,911 people whose doses were set using a standard approach. The trial's main focus was on measuring how often patients' blood-test results (called INR readings, which show how long it takes blood to clot) fell outside the target range at one month into treatment. The reported data shows that, looking at the primary outcome comparing PG-guided dosing against the parallel control group, about 31.2% of PG-guided patients had an out-of-range INR reading at one month, compared with 41.5% of the parallel control group. When the two different PG algorithms were compared with each other, 30.6% of those on the standard algorithm and 31.8% on the modified algorithm had out-of-range readings at one month. For secondary outcomes, the reported data shows that around 15.2% (standard algorithm) and 15.4% (modified algorithm) had INR readings that were either very high (4 or above) or very low (1.5 or below) by the end of follow-up. When serious adverse events were also counted alongside those extreme readings, the figures rose to 53.6% and 59.2% respectively. Regarding dose prediction, 63.2% of PG-guided patients had their long-term maintenance dose predicted accurately (within 1 mg per day), compared with 37.6% of the parallel control group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00262600 · results posted 10 February 2011

  According to the results reported on ClinicalTrials.gov, this trial (known as RE-LY) involved over 18,000 people across three groups: those taking dabigatran at a lower dose (110 mg), those taking dabigatran at a higher dose (150 mg), and those taking warfarin — a long-established blood-thinning medicine. Specifically, 6,015 people started in the lower-dose dabigatran group, 6,076 in the higher-dose dabigatran group, and 6,022 in the warfarin group. The trial was measuring how often participants experienced a stroke or a "systemic embolic event" (where a blood clot blocks a blood vessel somewhere in the body), as well as a range of other events including deaths, bleeding, and abnormal liver tests. The reported data shows that the main outcome — the yearly rate of stroke or systemic embolic events — was 1.54% for the lower-dose dabigatran group, 1.11% for the higher-dose dabigatran group, and 1.71% for the warfarin group. These are yearly event rates, meaning the estimated percentage of participants per year who experienced one of these events. For a combined measure that also included deaths from any cause, the reported yearly rates were 4.85%, 4.32%, and 5.20% respectively. For major bleeding (a serious concern with blood-thinning medicines), the reported yearly rates were 2.99%, 3.55%, and 3.81% across the three groups. Bleeding inside the skull was also tracked — the reported yearly rates for this were 0.23%, 0.32%, and 0.76% respectively. For abnormal liver test results, 11, 14, and 21 participants were reported across the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01227629 · results posted 10 February 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 502 participants across ten groups. Each group received a different combination of treatments: various doses of an investigational blood-thinning medicine called BIBR 1048 (also known as dabigatran) — taken twice daily at 50 mg, 150 mg, or 300 mg — either alone or combined with aspirin at two different doses (81 mg or 325 mg daily), plus one group receiving warfarin (a standard blood-thinning medicine, adjusted to a target blood level). The trial was measuring bleeding events of different severities, as well as serious cardiovascular events such as stroke and heart attack. The reported data shows the following for bleeding outcomes. For the most serious category — fatal or life-threatening bleeding — zero participants experienced such an event in most groups. The exception was 1 participant in the BIBR 1048 300 mg twice-daily plus low-dose aspirin group, and 3 participants in the BIBR 1048 300 mg twice-daily plus higher-dose aspirin group; no such events were recorded in the warfarin group. For the middle category of bleeding (clinically important but not life-threatening), the reported numbers ranged from 0 to 9 participants across the groups, with the highest count (9) in the BIBR 1048 150 mg twice-daily alone group. For minor or nuisance bleeding, counts ranged from 1 to 9 participants per group. Regarding serious cardiovascular events (such as stroke, heart attack, or death), the reported data shows small numbers only in the lower-dose BIBR 1048 groups (1–2 participants each), and zero events in the higher-dose BIBR 1048 groups and the warfarin group. No transient ischaemic attacks ("mini-strokes") were reported in any group. Some secondary outcome data appeared incomplete in the submitted results, so not all figures could be confirmed across every group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00249873 · results posted 26 March 2010

  According to the results reported on ClinicalTrials.gov, this trial enrolled 7,554 people in total — 3,772 in the group taking clopidogrel plus aspirin (ASA), and 3,782 in the group taking a placebo plus aspirin. The trial was measuring whether combining clopidogrel with aspirin made a difference compared to aspirin alone in people with atrial fibrillation (an irregular heart rhythm). The main thing researchers were tracking was whether participants experienced any of four serious events: stroke, a type of blood clot travelling to parts of the body outside the brain (called non-CNS systemic embolism), heart attack, or death from a vascular (blood vessel or heart-related) cause. The reported data shows that, for the primary combined outcome, 832 participants in the clopidogrel-plus-aspirin group experienced at least one of those four events, compared to 924 in the placebo-plus-aspirin group. Looking at the secondary outcomes individually: stroke occurred in 296 people in the clopidogrel group versus 408 in the placebo group; death from any cause was recorded in 825 people in the clopidogrel group versus 841 in the placebo group. The reported data also shows that major bleeding events were recorded in 251 participants in the clopidogrel group, compared to 162 in the placebo group. Please note that the primary outcome data contained multiple sets of figures that could not be fully matched to clearly labelled subgroups in the submitted data, so only the overall composite totals have been described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00174785 · results posted 23 December 2009

  According to the results reported on ClinicalTrials.gov, this trial (NCT00174785) involved 4,628 people with a heart rhythm condition called atrial fibrillation or atrial flutter. Participants were randomly assigned to take either dronedarone 400mg twice daily (2,301 people) or a placebo — a dummy pill with no active ingredient (2,327 people). The trial was measuring how many people experienced either a hospital admission for a heart- or blood vessel-related reason, or died from any cause, whichever happened first. Around 1,605 people in the dronedarone group and 1,611 in the placebo group completed the study. The reported data shows that for the main outcome — first cardiovascular-related hospitalisation or death from any cause — 734 people in the dronedarone group and 917 people in the placebo group experienced this event by the end of the study period. For deaths from any cause, the numbers reported were 116 in the dronedarone group and 139 in the placebo group. When looking only at hospitalisations for a cardiovascular reason, the reported figures were 675 (dronedarone) and 859 (placebo). For deaths specifically linked to the heart or blood vessels, as assessed by the treating doctors, 65 people in the dronedarone group and 94 in the placebo group were recorded. A separate review by an independent committee (who did not know which treatment participants had received) reported similar figures: 63 cardiovascular deaths in the dronedarone group and 90 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00313443 · results posted 6 August 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom completed the study with no dropouts. The trial was investigating a medicine called amiodarone (used for certain heart rhythm problems) and looked at whether measuring the amount of this medicine stored in body fat tissue — collected using a needle aspiration procedure — could be a useful way to understand how the drug behaves in the body. Specifically, the researchers were interested in whether fat tissue levels related to the total dose a person had received, to the level found in their blood at the same time, and to whether participants experienced unwanted side effects. The reported data shows three main findings, each expressed as a statistical measure of relationship (a number showing how closely two things move together). For the relationship between amiodarone levels in fat tissue and the total amount of the drug a person had taken over time, a correlation value of 0.20 was reported — a low number suggesting little connection between the two. For the relationship between fat tissue levels and blood levels measured at the same time, a correlation value of 0.68 was reported — a higher number suggesting a moderate link. For the relationship between fat tissue levels and whether a participant experienced side effects serious enough to stop the drug or require additional treatment, a value of 1.01 was reported (this type of figure, called an odds ratio, compares the likelihood of an outcome between groups — a value very close to 1.0 suggests little to no difference). On the secondary measures, the reported data shows that 2 out of 30 participants experienced pain or complications from the fat tissue needle procedure, and 11 out of 30 participants developed side effects attributed to amiodarone that required withdrawal of the drug or specific treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.