A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
Start Date
6/28/2024
Completion Date
6/30/2026
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.
Eligibility Criteria
Age Range: 18 years to 80 years
Interventions
OMNYPULSE™ Catheter with the TRUPULSE Generator
Conditions
Locations
Phoenix Cardiovascular Research Group
Phoenix, Arizona 85018
United States
Mills Peninsula Health Services
Burlingame, California 94010
United States
Scripps Clinic/Prebys Cardiovascular Institute
La Jolla, California 92037
United States
Cardiovascular Associates of Marin
Larkspur, California 94939
United States
Loma Linda Medical Center
Loma Linda, California 92354
United States
Hoag Memorial Hospital
Newport Beach, California 92663
United States
San Diego Cardiac Center
San Diego, California 92123
United States
California Pacific Medical Center- Sutter Health
San Francisco, California 94109
United States
Providence Saint John s Health Center
Santa Monica, California 90404
United States
University of Colorado
Aurora, Colorado 80045
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
Ascension St. Vincent's
Jacksonville, Florida 32204
United States
Baptist Health Research Institute
Jacksonville, Florida 32207
United States
HCA Florida Mercy Hospital
Miami, Florida 33133
United States
NCH Healthcare
Naples, Florida 34102
United States
Advent Health Orlando
Orlando, Florida 32803
United States
Piedmont Healthcare
Atlanta, Georgia 30309
United States
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Northside Hospital
Atlanta, Georgia 30342
United States
Memorial Health University Medical Center
Savannah, Georgia 31404
United States
NorthShore University Medical Center
Glenview, Illinois 60026
United States
Johns Hopkins
Baltimore, Maryland 21287
United States
Massachusetts General
Boston, Massachusetts 02114
United States
Brigham And Women's Hospital
Boston, Massachusetts 02115
United States
Beaumont Health Systems
Royal Oak, Michigan 48073
United States
Minneapolis Heart Institute
Minneapolis, Minnesota 55414
United States
Morristown Medical Center
Morristown, New Jersey 07960
United States
New Mexico Heart Institute
Albuquerque, New Mexico 87102
United States
Mount Sinai School of Medicine
New York, New York 10029
United States
New York Presbyterian - Weill Cornell Medical Ctr
New York, New York 10065
United States
Lenox Hill Hospital
New York, New York 10075
United States
St Francis Hospital
Roslyn, New York 11576
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
WakeMed Heart & Vascular
Raleigh, North Carolina 27610
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania 19104
United States
York Hospital
York, Pennsylvania 17403
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United States
Texas Heart Institute
Houston, Texas 77030
United States
Intermountain Medical Center
Murray, Utah 84107
United States
Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
Falls Church, Virginia 22042
United States
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
United States
Virginia Commonwealth University
Richmond, Virginia 23298
United States
Royal Adelaide Hospital
Adelaide, 5000
Australia
Canberra Heart Rhythm
Garran, 2605
Australia
Royal Melbourne Hospital
Parkville, 03052
Australia