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 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.
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 because you have episodes of atrial fibrillation (an irregular heartbeat) that causes symptoms, and at least one medication meant to control heart rhythm has not worked or you could not tolerate it
- Your doctor has noted that you have recurring episodes of atrial fibrillation that stop on their own
- You have had at least one episode of atrial fibrillation confirmed by a heart tracing (like an ECG) within the last 6 months before the ablation procedure
- You are at least 18 years old
- You are able and willing to follow all the requirements of the trial
- You have been fully informed about the trial, agreed to its terms, and signed a consent form approved by the relevant ethics board
Who may not be able to join:
- Your atrial fibrillation is long-lasting or does not stop on its own (persistent or long-standing)
- You have had four or more procedures to reset your heart rhythm (cardioversions) in the past 12 months
- You currently have an active infection affecting your whole body
- You are known to have a blood clot in your heart
- You already have an implanted heart device called a defibrillator (ICD)
- Your irregular heartbeat is caused by a treatable condition such as a thyroid problem, recent heavy alcohol use, or a major surgery in the past 3 months
- You have had a heart attack, a heart procedure involving your coronary arteries, or heart bypass or valve surgery in the past 3 months
- The upper left chamber of your heart is larger than a certain size (confirm with trial site)
- Your heart's pumping strength is below a certain level (confirm with trial site)
- You have more advanced heart failure symptoms, classified as NYHA Class III or IV (confirm with trial site)
- You have previously had a surgical or catheter procedure to treat atrial fibrillation in the left side of your heart
- You have had previous heart surgery that left scar tissue in the upper left chamber of your heart
- You have previously had a replacement or repair of your tricuspid or mitral heart valve
- You have a heart condition for which corrective surgery is expected within the next 6 months
- You have a condition that affects your blood's ability to clot properly
- You are unable to take long-term blood-thinning medication
- You have a physical condition that prevents suitable access to your blood vessels for the procedure
- Your kidneys are failing and you require dialysis
- You have a known allergy to contrast dye that cannot be managed with pre-medication (confirm with trial site)
- You have severe lung disease or another serious lung or breathing condition causing significant ongoing symptoms
- You are currently pregnant or breastfeeding
- You have other health conditions or physical factors that, in the doctor's opinion, would prevent you from fully participating in or completing the trial
- You are currently taking part in another clinical trial, or have done so within the last 30 days, in a way that could affect this trial
- You are not expected to survive for the full 12-month follow-up period of the trial
- Your body mass index (BMI) is over 40 (a measure of body weight relative to height)
- You are considered a vulnerable subject (confirm with trial site)
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 MBA, Abbott
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Rate of Serious Adverse Events; Number of Participants With Procedural Success
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.