RecruitingAtrial Fibrillation
A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation
Eligible age
18–80 yrs
Accepts
All genders
Locations
7 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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).
Sponsor: Biosense Webster, Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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 has severe dilatation of the LA (LAD \> 50 millimeters \[mm\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
- ✕ Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
- ✕ Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \[\<\] 40%) confirmed by imaging performed within 180 days prior to enrollment
- ✕ Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
Where it's recruiting
Arkansas
Jonesboro
California
Fountain Valley · Ventura
Florida
Naples
New York
New York · The Bronx
North Carolina
Raleigh
Texas
Austin · Plano
Utah
Murray
Source: ClinicalTrials.gov · NCT07523750 · last updated 2026-09-15