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RECRUITING
NCT07523750
NA

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

Sponsor: Biosense Webster, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

466

Start Date

2026-04-02

Completion Date

2028-05-31

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DEVICE

VARIPULSE Catheter

Pulsed Field Ablation using the VARIPULSE catheter.

DEVICE

FARAWAVE Catheter

Pulsed field ablation using the FARAWAVE catheter.

Locations (11)

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Lenox Hill Hospital

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

WakeMed Hospital

Raleigh, North Carolina, 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