Recruiting

VARIPULSE vs. FARAWAVE

Sponsor:

Biosense Webster, Inc.

Code:

NCT07523750

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

VARIPULSE Catheter

FARAWAVE Catheter

Study Details

Brief 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).

Conditions

Atrial Fibrillation

Study ID

NCT07523750

Start date

Apr 2, 2026

Status verified date

Aug, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 (that is, 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

Study Design

Enrollment

566 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VARIPULSE Pulsed Field Ablation (PFA) Catheter

Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure.

active comparator: FARAWAVE PFA Catheter

Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure.

Interventions

VARIPULSE Catheter

Pulsed Field Ablation using the VARIPULSE catheter.

FARAWAVE Catheter

Pulsed field ablation using the FARAWAVE catheter.

Primary outcome measure

  • Occurrence of Early Onset Primary Adverse Events (PAEs) [ Time Frame: Up to 7 days post-index procedure ]
  • Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes [ Time Frame: Day 61 and onward ]

Central Contacts and Locations

Central contacts

Jesal Parekh

1 858 2108727jparekh@its.jnj.com

Josiah M Gillespie

14059240777jgille12@its.jnj.com

Locations

Arrhythmia Research Group

Recruiting

Jonesboro, Arkansas, United States, 72401

OC Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Lenox Hill Hospital

Recruiting

New York, New York, United States, 10075

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Texas Cardiac Arrhythmia Research Foundation

Recruiting

Austin, Texas, United States, 78705

More Information

Sponsor

Biosense Webster, Inc.

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biosense Webster, Inc. on 2026-08-05.