Recruiting

VARIPULSE

Sponsor:

Biosense Webster, Inc.

Code:

NCT07227532

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Study Details

Brief summary:

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).

Conditions

Atrial Fibrillation

Study ID

NCT07227532

Start date

Oct 21, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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 Design

Enrollment

276 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.

Primary outcome measure

  • Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure [ Time Frame: Within 7 days post index procedure ]
  • Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes [ Time Frame: Day 61-1095 post-index procedure ]

Central Contacts and Locations

Central contacts

Emily Purcell

+1 949 230 3701EPurcel1@its.jnj.com

Locations

Phoenix Cardiovascular Research Group

Recruiting

Phoenix, Arizona, United States, 85018

Tucson Medical Center Pima Heart and Vascular

Recruiting

Tucson, Arizona, United States, 85704

OC Memorial

Recruiting

Fountain Valley, California, United States, 92708

Community Memorial Hospital

Recruiting

Ventura, California, United States, 93003

Aurora Denver Cardiology Associates

Recruiting

Aurora, Colorado, United States, 80012

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224

HCA Florida Mercy Hospital

Recruiting

Miami, Florida, United States, 33133

Orlando Health Heart and Vascular Institute

Recruiting

Orlando, Florida, United States, 32806

Edward Hospital Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

The Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Trinity Health

Recruiting

Ypsilanti, Michigan, United States, 48197

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Northwell Health Physician Partners Cardiology

Recruiting

Lake Success, New York, United States, 11042

Albert Einstein College Of Medicine - Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Springfield Medical Center

Recruiting

Springfield, Ohio, United States, 45504

Texas Cardiac Arrhythmia Research Foundation

Recruiting

Austin, Texas, United States, 78705

Baylor Scott and White Research Institute

Recruiting

Fort Worth, Texas, United States, 76104

Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Winchester Medical Center

Recruiting

Winchester, Virginia, United States, 22601

Mercy Hospital

Recruiting

Janesville, Wisconsin, United States, 53548

More Information

Sponsor

Biosense Webster, Inc.

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Biosense Webster, Inc. on 2026-08-31.