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

NCT07523750 | Recruiting DMC FDA Device

• 1 other identifier: BWI202516
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 11

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

Outcome Measures

Primary Outcomes (2)

• Occurrence of Early Onset Primary Adverse Events (PAEs)

  PAEs that include early onset AEs such as esophageal perforating complications, phrenic nerve paralysis (PNP; permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), death (device or procedure related), stroke/ cerebrovascular accident (CVA), major vascular access, complication/bleeding, thromboembolism, myocardial infarction (MI), transient ischemic attack (TIA), pericarditis, pulmonary edema (respiratory insufficiency), heart block, and vagal nerve injury/ gastroparesis.

  Up to 7 days post-index procedure

• Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes

  Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.

  Day 61 and onward

Secondary Outcomes (1)

• Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score

  Baseline, at 6 months and at 12 months post-index procedure

Study Arms (2)

VARIPULSE Pulsed Field Ablation (PFA) Catheter

EXPERIMENTAL

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.

Device: VARIPULSE Catheter

FARAWAVE PFA Catheter

ACTIVE COMPARATOR

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.

Device: FARAWAVE Catheter

Interventions

VARIPULSE Catheter DEVICE

Pulsed Field Ablation using the VARIPULSE catheter.

VARIPULSE Pulsed Field Ablation (PFA) Catheter

FARAWAVE Catheter DEVICE

Pulsed field ablation using the FARAWAVE catheter.

FARAWAVE PFA Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (11)

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

NOT YET RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

NOT YET RECRUITING

WakeMed Hospital

Raleigh, North Carolina, 27610, United States

NOT YET RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

RECRUITING

Baylor Research Institute

Plano, Texas, 75093, United States

NOT YET RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jesal Parekh

CONTACT

1 858 2108727; jparekh@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (11)