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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.
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
566
Start Date
2026-04-02
Completion Date
2028-05-31
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
VARIPULSE Catheter
Pulsed Field Ablation using the VARIPULSE catheter.
FARAWAVE Catheter
Pulsed field ablation using the FARAWAVE catheter.
Locations (30)
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
OC Medical Center
Fountain Valley, California, United States
Stanford University Medical Center
Stanford, 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