RecruitingNot ApplicableNCT06455098

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

Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

Sponsor

Biosense Webster, Inc.

Enrollment

440 participants

Start Date

Jun 28, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study assesses the safety and effectiveness of a catheter ablation system called OMNYPULSE — which uses pulsed field ablation (PFA) to treat paroxysmal atrial fibrillation (AF), a type of irregular heartbeat that comes and goes. PFA uses rapid electrical pulses to destroy heart tissue causing the abnormal rhythm, potentially with fewer complications than heat-based methods. **You may be eligible if...** - You have been diagnosed with symptomatic paroxysmal AF (episodes that start and stop on their own) - You have had at least 2 symptomatic AF episodes in the past 6 months - At least one AF episode was confirmed by ECG within the past 12 months - At least one antiarrhythmic medication has not worked for you **You may NOT be eligible if...** - You have had any prior ablation or surgical procedure for AF - You have persistent AF (lasting more than 7 days) - You have a blood clot in the heart, severely enlarged left atrium, or weakened heart pump function - You have a pacemaker or other cardiac implant that could interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOMNYPULSE™ 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

View Full Details on ClinicalTrials.gov

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NCT06455098

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