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NCT06455098NARecruiting

A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

Biosense Webster, Inc.

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

Inclusion Criteria: * Diagnosed with symptomatic paroxysmal AF with: 1. At least two symptomatic AF episodes within last six months from enrollment 2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment * Failed at least one Class I or Class III antiarrhythmic drug * Willing and capable to provide consent * Able and willing to comply with all pre-, post- and follow-up testing and requirements Exclusion Criteria: * Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration) * AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause. * Previous surgical or catheter ablation for AF * Patients known to require ablation outside the PV ostia and outside the CTI region. * Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment * Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure * Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment * Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV * History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran) * Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months * Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months * Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months * Valvular cardiac surgical/percutaneous procedure * Unstable angina within 6 months * Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months * Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms * Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study * Prior diagnosis of pulmonary vein stenosis * Pre-existing hemi diaphragmatic paralysis * Acute illness, active systemic infection, or sepsis * Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation * Severe mitral regurgitation * Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field) * Presence of a condition that precludes vascular access * Current enrollment in an investigational study evaluating another device or drug * Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation * Life expectancy less than 12 months * Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Interventions

DEVICE

OMNYPULSE™ Catheter with the TRUPULSE Generator

Interested in This Trial?

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Conditions

Atrial Fibrillation

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