RecruitingNot ApplicableNCT07227532

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

BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System

Sponsor

Biosense Webster, Inc.

Enrollment

276 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the long-term safety and effectiveness of the VARIPULSE catheter system — a device that uses pulsed electric fields to treat atrial fibrillation (an irregular heartbeat) by targeting the area around the pulmonary veins in the heart. **You may be eligible if...** - You have symptomatic paroxysmal (comes and goes) atrial fibrillation - You have tried or considered at least one anti-arrhythmic medication that was not effective, not tolerated, or not wanted - Your doctor believes catheter ablation is appropriate for you - You are willing and able to attend all required follow-up visits **You may NOT be eligible if...** - You have persistent or long-standing persistent atrial fibrillation (lasting more than 7 days) - You have previously had catheter or surgical ablation for atrial fibrillation - You have a significant structural heart problem or congenital condition - You are currently enrolled in another device or drug trial - Your life expectancy is less than 12 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator

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

Locations(23)

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Tucson Medical Center Pima Heart and Vascular

Tucson, Arizona, United States

OC Memorial

Fountain Valley, California, United States

San Diego Cardiac Center

San Diego, California, United States

Stanford Hospital and Clinics

Stanford, California, United States

Community Memorial Hospital

Ventura, California, United States

Aurora Denver Cardiology Associates

Aurora, Colorado, United States

Colorado Heart and Vascular PC

Golden, Colorado, United States

HCA Florida Mercy Hospital

Miami, Florida, United States

Orlando Health Heart and Vascular Institute

Orlando, Florida, United States

Deaconess Gateway Hospital

Newburgh, Indiana, United States

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Norton Heart and Vascular Institute

Louisville, Kentucky, United States

Trinity Health

Ypsilanti, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Albert Einstein College Of Medicine - Montefiore Medical Center

The Bronx, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Springfield Medical Center

Springfield, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Scott and White Research Institute

Fort Worth, Texas, United States

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

Plano, Texas, United States

Winchester Medical Center

Winchester, Virginia, United States

Mercy Hospital

Janesville, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07227532

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