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A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Sponsor: Biosense Webster, Inc.
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).
Official title: BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
276
Start Date
2025-10-21
Completion Date
2030-12-31
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Pulsed 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
Community Memorial Hospital
Ventura, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States
Edward Hospital Midwest Cardiovascular Institute
Naperville, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Trinity Health
Ypsilanti, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Northwell Health Physician Partners Cardiology
Lake Success, New York, 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