A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatm… (NCT07523750) | Clinical Trial Compass
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A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
United States466 participantsStarted 2026-04-02
Plain-language summary
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria:
* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \[\>\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
* Participant is aged 18 - 80 years at the time of informed consent
* Participant is willing and capable of providing informed consent
* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements
Exclusion criteria:
* Participant has continuous AF \> 365 days (longstanding persistent AF)
* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)
* Participant has had previous surgical or catheter ablation for AF
* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)
* Participant …
What they're measuring
1
Occurrence of Early Onset Primary Adverse Events (PAEs)
Timeframe: Up to 7 days post-index procedure
2
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes