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A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Sponsor: Biosense Webster, Inc.
Summary
The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.
Official title: Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2024-06-28
Completion Date
2026-06-30
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.
Locations (46)
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Mills Peninsula Health Services
Burlingame, California, United States
Scripps Clinic/Prebys Cardiovascular Institute
La Jolla, California, United States
Cardiovascular Associates of Marin
Larkspur, California, United States
Loma Linda Medical Center
Loma Linda, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
San Diego Cardiac Center
San Diego, California, United States
California Pacific Medical Center- Sutter Health
San Francisco, California, United States
Providence Saint John s Health Center
Santa Monica, California, United States
University of Colorado
Aurora, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Ascension St. Vincent's
Jacksonville, Florida, United States
Baptist Health Research Institute
Jacksonville, Florida, United States
HCA Florida Mercy Hospital
Miami, Florida, United States
NCH Healthcare
Naples, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
NorthShore University Medical Center
Glenview, Illinois, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General
Boston, Massachusetts, United States
Brigham And Women's Hospital
Boston, Massachusetts, United States
Beaumont Health Systems
Royal Oak, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
St Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
WakeMed Heart & Vascular
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Texas Heart Institute
Houston, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Royal Adelaide Hospital
Adelaide, Australia
Canberra Heart Rhythm
Garran, Australia
Royal Melbourne Hospital
Parkville, Australia