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. TactiCathâ„¢ Contact Force Ablation Catheter, Sensor Enabledâ„¢ (TactiCath SE)) for the treatment of AF.
Who can participate
SexALL
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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
✕. 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
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