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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBiosense Webster, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • VARIPULSE Catheter
  • FARAWAVE Catheter

Treatment groups

466 Participants
are divided into 2 treatment groups

Sponsors and collaborators