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NCT07227532NARecruiting

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

Biosense Webster, Inc.

Start Date

10/21/2025

Completion Date

12/31/2030

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).

Eligibility Criteria

Age Range: 22 years to No maximum

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

Interventions

DEVICE

Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

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Conditions

Atrial Fibrillation

Locations

Phoenix Cardiovascular Research Group

Phoenix, Arizona 85018

United States

Tucson Medical Center Pima Heart and Vascular

Tucson, Arizona 85704

United States

OC Memorial

Fountain Valley, California 92708

United States

San Diego Cardiac Center

San Diego, California 92123

United States

Stanford Hospital and Clinics

Stanford, California 94305

United States

Community Memorial Hospital

Ventura, California 93003

United States

Aurora Denver Cardiology Associates

Aurora, Colorado 80012

United States

Colorado Heart and Vascular PC

Golden, Colorado 80401

United States

HCA Florida Mercy Hospital

Miami, Florida 33133

United States

Orlando Health Heart and Vascular Institute

Orlando, Florida 32806

United States

Deaconess Gateway Hospital

Newburgh, Indiana 47630

United States

The Kansas City Heart Rhythm Institute

Overland Park, Kansas 66211

United States

Norton Heart and Vascular Institute

Louisville, Kentucky 40205

United States

Trinity Health

Ypsilanti, Michigan 48197

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Albert Einstein College Of Medicine - Montefiore Medical Center

The Bronx, New York 10467

United States

The Christ Hospital

Cincinnati, Ohio 45229

United States

Springfield Medical Center

Springfield, Ohio 45504

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas 78705

United States

Baylor Scott and White Research Institute

Fort Worth, Texas 76104

United States

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

Plano, Texas 75093

United States

Winchester Medical Center

Winchester, Virginia 22601

United States

Mercy Hospital

Janesville, Wisconsin 53548

United States