A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation

NCT07527299 | Recruiting DMC FDA Device

• 1 other identifier: BWI202517
• Study Type: interventional
• Target: 1,070
• Locations: 2 countries
• Sites: 27

Brief Summary

The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \[PVI\] and superior vena cava isolation \[SVCI\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Early Onset Primary Adverse Events (PAEs)

  PAEs 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 approximately 7 days post-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 (DC) cardioversion procedure.

  Day 61 up to Day 180

Secondary Outcomes (2)

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

  Day 61 up to Day 365

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

  Baseline, at 12 months post-procedure

Study Arms (2)

VARIPULSE Catheter System: PVI and SVCI

EXPERIMENTAL

Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation for the first-time with the VARIPULSE Catheter System will undergo the ablation procedure for PVI and SVCI. Additionally, a subset of participants will undergo a concomitant left atrial appendage occlusion (LAAO) procedure. All participants will be followed for up to 36 months post procedure.

Device: VARIPULSE Catheter System; Device: LAAO Device

VARIPULSE Catheter System: PVI and SVCI + PWI

EXPERIMENTAL

Participants with PsAF undergoing catheter ablation for the first-time with VARIPULSE catheter system will undergo the ablation procedure for PVI and SVCI along with posterior wall isolation (PWI). Additionally, a subset of participants will undergo a concomitant LAAO procedure. All participants will be followed for up to 36 months post procedure.

Device: VARIPULSE Catheter System; Device: LAAO Device

Interventions

LAAO Device DEVICE

LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).

VARIPULSE Catheter System: PVI and SVCI; VARIPULSE Catheter System: PVI and SVCI + PWI

VARIPULSE Catheter System DEVICE

Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.

VARIPULSE Catheter System: PVI and SVCI; VARIPULSE Catheter System: PVI and SVCI + PWI

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 in duration 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 (ECGs) 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 requirement
• Left atrial appendage occlusion (LAAO) concomitant subset:
• \- Participant is clinically indicated for a LAAO procedure

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 LA (left atrial) anteroposterior \>= 55 millimeter (mm) (by magnetic resonance imaging \[MRI\], computed tomography \[CT\], or transthoracic echocardiogram \[TTE\]), or if LA diameter is not available, non-index volume \>100 milliliter (mL) confirmed within 365 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 (left ventricle ejection fraction \[LVEF\] less than \[\<\] 40 percent \[%\]) 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 functional classification
• Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
• Participant has had a thromboembolic event (including transient ischemic attack \[TIA\]) within the past 180 days prior to enrollment
• Participant has had a percutaneous coronary intervention or acute myocardial infarction (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 (27)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

NOT YET RECRUITING

Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG

Phoenix, Arizona, 85018, United States

NOT YET RECRUITING

Honorhealth

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

Tucson Medical Center

Tucson, Arizona, 85712, United States

WITHDRAWN

Pima Heart and Vascular

Tucson, Arizona, 85741, United States

RECRUITING

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

NOT YET RECRUITING

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

Marin General Hospital

Larkspur, California, 94939, United States

NOT YET RECRUITING

Hoag Memorial Hospital

Newport, California, 92663, United States

NOT YET RECRUITING

Pacific Heart Institute Cedars Sinai Medical Center

Santa Monica, California, 90404, United States

NOT YET RECRUITING

Aurora Denver Cardiology Associates

Aurora, Colorado, 80012, United States

NOT YET RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

NOT YET RECRUITING

JFK Medical Center

Atlantis, Florida, 33462, United States

NOT YET RECRUITING

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

NOT YET RECRUITING

Saint Elizabeth Medical Center

Edgewood, Kentucky, 41017, United States

NOT YET RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

NOT YET RECRUITING

Albert Einstein College Of Medicine - Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Lindner Clinical Trial Center/Christ Hospital

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

NOT YET RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

NOT YET RECRUITING

Houston Methodist Sugarland

Sugar Land, Texas, 77479, United States

NOT YET RECRUITING

Mercy Hospital

Janesville, Wisconsin, 53548, United States

NOT YET RECRUITING

Monash Health Victorian Heart Hospital

Clayton, 3168, Australia

NOT YET RECRUITING

John Hunter Hospital

New Lambton Heights, 2305, Australia

NOT YET RECRUITING

Westmead Hospital

Westmead, 2145, Australia

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

Narvelle Delabruere

CONTACT

949-933-1710; NDelabru@its.jnj.com

Josiah M Gillespie

CONTACT

405-924-0777; jgille12@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): August 4, 2031
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); US (24)