Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Atrial Fibrillation Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You are planning to have a catheter ablation procedure for atrial fibrillation (a heart rhythm problem) that causes symptoms
- Your doctor has noted that your atrial fibrillation episodes come and go on their own
- You have had at least one atrial fibrillation episode recorded by a heart monitor (ECG) in the past 12 months, lasting at least 30 seconds
- You are 18 years of age or older
- You are able and willing to follow all the requirements of the trial
- You have been fully informed about the trial and have signed a written consent form
Who may not be able to join:
- Your atrial fibrillation is persistent (does not stop on its own) or long-lasting
- You currently have an active infection anywhere in your body
- You have a known blood clot in your heart
- You have a condition called hypertrophic cardiomyopathy (a specific type of heart muscle thickening)
- Your irregular heart rhythm is caused by a treatable condition such as a thyroid problem, recent heavy alcohol use, or major surgery in the past 90 days
- You have had a heart attack, a heart procedure to open blocked arteries, or heart bypass or valve surgery in the past 90 days
- The upper left chamber of your heart is larger than a certain size, measured by a scan in the last 180 days (confirm with trial site)
- Your heart's pumping strength is below a certain level, measured by a scan in the last 180 days (confirm with trial site)
- You have been told you have severe heart failure symptoms (New York Heart Association class III or IV) (confirm with trial site)
- You have previously had a catheter ablation or surgery on the left side of your heart
- You have scarring in the left upper chamber of your heart from a previous procedure, including a device to close off a part of the heart called the left atrial appendage
- You have previously had a heart valve replaced or repaired (tricuspid or mitral valve)
- You are expected to need corrective heart surgery within 180 days after the procedure
- You have a condition that affects your blood's ability to clot normally
- You cannot safely take blood-thinning medication long term
- You have a physical condition that would make it difficult to access your blood vessels for the procedure
- You require dialysis for kidney failure
- You have a known allergy to contrast dye (used during some procedures) that cannot be managed with medication beforehand
- You have severe lung disease or a serious ongoing breathing condition
- You are currently pregnant or breastfeeding
- You have another health, personal, or psychological condition that the trial doctor believes would prevent you from safely taking part or completing the trial
- You are currently in another clinical trial, or have taken part in one within the last 30 days that might affect this trial
- You are unlikely to survive the 12-month follow-up period after the procedure
- Your body mass index (BMI) is above 40 (confirm with trial site)
- You do not have the legal authority to make your own decisions (confirm with trial site)
- You are unable to read or write
- You have had certain types of heart surgery (on the heart chambers) within the past 4 weeks before the procedure
- You have an artificial (prosthetic) heart valve
- You have a non-cancerous heart tumour called a myxoma
- You have a patch or baffle between the upper chambers of your heart from a previous procedure
- You cannot receive heparin (a blood thinner) or a suitable alternative during the procedure
- You have had a stroke or mini-stroke (TIA) in the last 90 days
- You have a narrowing or blockage in one of the veins connected to your lungs (pulmonary veins)
- You have rheumatic heart disease
- You have a severely leaky mitral heart valve (severe mitral regurgitation)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Kristin Ruffner, PhD, Clinical Program Director
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Device or Procedure-related Serious Adverse Events; KM Rate of Freedom From Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.