Clinical trial Recruiting at 20 sites Interventional Ages 18 to 80

VARIPULSE versus FARAWAVE pulsed field catheters for persistent atrial fibrillation

Official title: Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial

Run by Biosense Webster, Inc. · NCT07523750 · Data updated 2026-11-12

This compares the VARIPULSE pulsed field ablation catheter with the FDA-approved FARAWAVE catheter to see which is safer and works better for adults with symptomatic persistent atrial fibrillation.

More Atrial Fibrillation trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment566 (estimated)
SponsorBiosense Webster, Inc.
Industry-sponsored
Locations20 sites (Jonesboro, Arkansas and 19 other locations)
StatusRecruiting
StartedApril 2, 2026
Main results expectedMay 31, 2028
Study endsMay 31, 2028
Registry record updatedNovember 3, 2026
Trial IDNCT07523750 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18–80 with symptomatic persistent AF lasting more than 7 days but less than 365 days, who can give informed consent and complete required follow-up, are eligible candidates.

Probably not a fit

People with longstanding persistent AF (>365 days), AF caused by electrolyte imbalance or thyroid disease, those outside the 18–80 age range, or those unable to undergo ablation or follow-up are unlikely to receive benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–80 with symptomatic persistent atrial fibrillation (continuous AF lasting more than 7 days but less than 365 days) will receive pulsed field ablation using either the investigational VARIPULSE catheter or the FDA-approved FARAWAVE catheter. The trial will track procedure outcomes, safety events, and heart-rhythm monitoring over follow-up to measure AF recurrence and complications. Enrollment requires documented continuous AF and the ability to comply with pre-, peri-, and post-procedure testing and visits. The study is sponsored by Biosense Webster and is being conducted at an Arrhythmia Research Group site in Jonesboro, Arkansas.

Why it matters

Potential benefit: If successful, it could provide an additional PFA catheter option that matches or improves on the safety and effectiveness of current FDA-approved devices for persistent AF.

How similar studies have gone: Other pulsed field ablation devices, including the FDA-cleared FARAWAVE, have shown promising safety and efficacy in prior studies, while VARIPULSE is still investigational.

Who can join: the full rules

Show full inclusion / exclusion criteria
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 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
* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment
* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment
* Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)
* Participant has unstable angina within past 6 months prior to enrollment
* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
* Participant has a significant congenital anomaly (for example, atrial septal defects \[ASDs\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
* Participant has a pre-existing hemi-diaphragmatic paralysis
* Participant has an acute illness, active systemic infection, or sepsis
* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \[\>=\] 60 milliliters \[mL\]/beat, regurgitant fraction \>= 50 percent \[%\], and/or effective regurgitant orifice area \>= 0.40 square centimeter \[cm\^2\])
* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \[ILR\])
* Participant has a condition that precludes vascular access (such as inferior vena cava \[IVC\] filter)
* Participant is currently enrolled in an investigational study evaluating another device or drug
* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
* Participant has a life expectancy less than 365 days

For magnetic resonance imaging (MRI) subset:

* Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera
* Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI
* Unresolved pre-existing neurological deficit

Where it's running

  • Arrhythmia Research Group
    Jonesboro, Arkansas, United States
    Recruiting
  • OC Medical Center
    Fountain Valley, California, United States
    Recruiting
  • Community Memorial Hospital
    Ventura, California, United States
    Recruiting
  • St. Vincents Medical Center
    Jacksonville, Florida, United States
    Recruiting
  • HCA Florida Mercy Hospital
    Miami, Florida, United States
    Recruiting
  • NCH Healthcare
    Naples, Florida, United States
    Recruiting
Show 14 more locations
  • Emory Saint Joseph's Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Memorial Health University Medical Center
    Savannah, Georgia, United States
    Recruiting
  • Baptist Health Lexington
    Lexington, Kentucky, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, United States
    Recruiting
  • Trinity Health Michigan Heart - Ann Arbor Campus
    Ypsilanti, Michigan, United States
    Recruiting
  • Rutgers Robert Wood Johnson Medical School
    New Brunswick, New Jersey, United States
    Recruiting
  • Lenox Hill Hospital
    New York, New York, United States
    Recruiting
  • Rochester General Hospital
    Rochester, New York, United States
    Recruiting
  • Montefiore Medical Center
    The Bronx, New York, United States
    Recruiting
  • WakeMed Hospital
    Raleigh, North Carolina, United States
    Recruiting
  • Texas Cardiac Arrhythmia Research Foundation
    Austin, Texas, United States
    Recruiting
  • Baylor Research Institute
    Plano, Texas, United States
    Recruiting
  • Intermountain Medical Center
    Murray, Utah, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.