RecruitingNot ApplicableNCT07523750

A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation

Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial

Sponsor

Biosense Webster, Inc.

Enrollment

566 participants

Start Date

Apr 2, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called FARAWAVE Catheter and a medical device called VARIPULSE Catheter for people with atrial fibrillation. The study is currently recruiting participants at 11 locations. People eligible for this study include aged 18 Years to 80 Years.

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

DEVICEVARIPULSE Catheter

Pulsed Field Ablation using the VARIPULSE catheter.

DEVICEFARAWAVE Catheter

Pulsed field ablation using the FARAWAVE catheter.

Locations(29)

Arizona Arrhythmia Research Center

Phoenix, Arizona, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

OC Medical Center

Fountain Valley, California, United States

Community Memorial Hospital

Ventura, California, United States

St. Vincents Medical Center

Jacksonville, Florida, United States

HCA Florida Mercy Hospital

Miami, Florida, United States

NCH Healthcare

Naples, Florida, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Endeavor Health Glenbrook Hospital

Glenview, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

The Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Tulane University Heart & Vascular Institute

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, United States

Trinity Health Michigan Heart - Ann Arbor Campus

Ypsilanti, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Lenox Hill Hospital

New York, New York, United States

Rochester General Hospital

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

WakeMed Hospital

Raleigh, North Carolina, United States

York Hospital

York, Pennsylvania, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Baylor Research Institute

Plano, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

University of Wisconsin At Madison

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07523750

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