Abbott Atrial Fibrillation Post Approval Study (NCT05434650) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Abbott Atrial Fibrillation Post Approval Study
United States200 participantsStarted 2022-10-21
Plain-language summary
This post-approval study is designed to provide continued real-world clinical evidence to confirm the safety and long-term effectiveness of atrial fibrillation (AF) radiofrequency (RF) technologies (e.g. TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)) for the treatment of AF.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject must provide written informed consent prior to any clinical investigation-related procedure.
. Documented symptomatic persistent AF, which is defined as continuous AF sustained beyond 7 days and less than 1 year that is documented by a physician's note AND one of the following:
. a 24-hour Holter within 180 days prior to consent/enrollment, showing continuous AF OR
. two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
. Subject must have failed, intolerance, or contraindication to a Class I-IV AAD medication.
. Able and willing to comply with all pre-, post-, and follow-up testing and requirements
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with freedom from AF recurrence post 90-day blanking period at 12 months
Timeframe: 12 months
2
Rate of device and/or procedure-related serious adverse events (SAE) with onset within 7-days of the index ablation procedure
. Previously diagnosed continuous AF \>12 months (longstanding persistent AF)
. Previous left atrial surgical or catheter ablation for atrial fibrillation or a previous procedure that required an incision in the left atrium with resulting scar
. Documented or known intracardiac thrombus on imaging
. History of atriotomy or ventriculotomy within 4 weeks prior to the initial procedure
. Patients with prosthetic valves
. Diagnosed atrial myxoma
. Acute illness or active systemic infection or sepsis
. Patient is unlikely to survive the protocol follow up period of 36 months