RecruitingNot Applicable

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

United States566 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 range

18 Years – 80 Years

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: * 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 …

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.

1This trial is comparing two specific pulsed field ablation catheters — the VARIPULSE and the FARAWAVE — for persistent atrial fibrillation; can you explain how pulsed field ablation differs from the ablation approaches I might get outside of a trial, and why that matters for my situation?
2Since this study is listed as Phase NA and is actively recruiting, what is actually known so far about the safety profile of these two catheters, and what types of early adverse events are they specifically watching for in participants?
3The trial is measuring how long it takes for atrial tachyarrhythmia episodes to come back after the procedure — does that mean there's still uncertainty about how durable the results will be, and how does that compare to what I could expect from a standard ablation done today?
4Given that I have persistent atrial fibrillation, which tends to be harder to treat than paroxysmal AFib, do you think my specific pattern of AFib makes me a realistic candidate to discuss for this trial, or would a proven standard-of-care approach be a better starting point for me?
5What would my follow-up schedule look like if I were to discuss enrolling in this trial — would the monitoring required to track arrhythmia recurrence fit with my work and daily life commitments?

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

Occurrence of Early Onset Primary Adverse Events (PAEs)

Timeframe: Up to 7 days post-index procedure

Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes

Timeframe: Day 61 and onward

Trial details

NCT IDNCT07523750

SponsorBiosense Webster, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-05-31

Contact for this trial

Jesal Parekh

1 858 2108727 jparekh@its.jnj.com

View on ClinicalTrials.gov More Atrial Fibrillation trials