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

May 7, 2026 updated by: Biosense Webster, Inc.

Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial

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; PVI and 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

920

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Tucson Medical Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Arrhythmia Research Group
    • New York
      • The Bronx, New York, United States, 10467
        • Albert Einstein College of Medicine - Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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

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 (left atrial diameter [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 (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
  • 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%, and/or Effective regurgitant orifice area >= 0.40 square centimeter [cm^2])
  • Participant has an implanted metal cardiac device (other than coronary stents, implanted pacemaker, implantable cardioverter-defibrillator [ICD], implantable loop recorder [ILR]) that may interfere with the pulsed field (PF) energy field
  • 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 of less than 365 days
  • Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)
  • Participant has contraindications for the ablation of the SVC

LAAO concomitant subset:

  • Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device
  • Participant with prior LAAO procedure (attempted or successful)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VARIPULSE Catheter System: PVI and SVCI

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
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
Device: LAAO Device
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).
Experimental: VARIPULSE Catheter System: PVI and SVCI + PWI
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
Pulsed field ablation by VARIPULSE Catheter System (VARIPULSE bi-directional catheter and TRUPULSE generator) will be used.
Device: LAAO Device
LAAO procedures will be performed using commercially available LAAO devices in accordance with the device's instruction for use (IFU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Early Onset Primary Adverse Events (PAEs)
Time Frame: Up to approximately 7 days post-procedure
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
Time Frame: Day 61 up to Day 180
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
Time Frame: Day 61 up to Day 365
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, AF, AT or AFL of unknown origin) episodes based on electrocardiographic and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, NSC failure, AAD failure and any DC cardioversion (DCCV) procedure.
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
Time Frame: Baseline, at 6 months and at 12 months post-procedure
The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.
Baseline, at 6 months and at 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosense Webster, Inc.

Investigators

  • Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 29, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

May 23, 2031

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BWI202517 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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