A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System (AdmIREPAS)

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

Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System

The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

276

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
      • Phoenix, Arizona, United States, 85018
        • Recruiting
        • Phoenix Cardiovascular Research Group
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Tucson Medical Center Pima Heart and Vascular
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • OC Memorial
      • Ventura, California, United States, 93003
        • Recruiting
        • Community Memorial Hospital
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Heart and Vascular Institute
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • The Kansas City Heart Rhythm Institute
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health
    • New York
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Albert Einstein College of Medicine - Montefiore Medical Center
    • Ohio
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Texas Cardiac Arrhythmia Research Foundation
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Winchester Medical Center
    • Wisconsin
      • Janesville, Wisconsin, United States, 53548
        • Recruiting
        • Mercy Hospital

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:

  • Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF
  • Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)
  • Willing and capable of providing consent
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements

Exclusion Criteria:

  • Previously diagnosed with persistent or long-standing persistent AF (more than [>] 7 days in duration)
  • Previous surgical or catheter ablation for AF
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF
  • Current enrollment in an investigational study evaluating another device or drug
  • Life expectancy less than 12 months
  • Any contraindications as defined in the Protocol

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator.
Device: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure
Time Frame: Within 7 days post index procedure
PAE's will include the following adverse events: atrio-esophageal fistula, phrenic nerve paralysis, cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency), and vagal nerve injury/gastroparesis.
Within 7 days post index procedure
Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes
Time Frame: Day 61-1095 post-index procedure
Freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmias (atrial fibrillation [AF], atrial tachycardia [AT] or atrial flutter [AFL] of unknown origin) episodes will be reported. AFL of unknown origin is defined as all AFL except those Cavotricuspid isthmus CTI dependent AFL as confirmed by 12-Lead electrocardiogram (ECG) and entrainment maneuvers in an evaluation period study.
Day 61-1095 post-index 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 (Actual)

October 21, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 11, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 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

  • BWI202405 (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 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

product manufactured in and exported from the U.S.

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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