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

NCT06455098 | Recruiting FDA Device

• 1 other identifier: BWI202303
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 46

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Primary Adverse Events (PAEs)

  Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.

  7 days post-procedure

• Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes

  Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of \>= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.

  Day 91 to Day 365 post-procedure

Secondary Outcomes (1)

• Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score

  Baseline, Month 12

Study Arms (1)

Pulsed Field (PF) Ablation System

EXPERIMENTAL

Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.

Device: OMNYPULSE™ Catheter with the TRUPULSE Generator

Interventions

OMNYPULSE™ Catheter with the TRUPULSE Generator DEVICE

OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

Pulsed Field (PF) Ablation System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with symptomatic paroxysmal AF with:
• At least two symptomatic AF episodes within last six months from enrollment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (46)

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85018, United States

RECRUITING

Mills Peninsula Health Services

Burlingame, California, 94010, United States

RECRUITING

Scripps Clinic/Prebys Cardiovascular Institute

La Jolla, California, 92037, United States

WITHDRAWN

Cardiovascular Associates of Marin

Larkspur, California, 94939, United States

RECRUITING

Loma Linda Medical Center

Loma Linda, California, 92354, United States

WITHDRAWN

Hoag Memorial Hospital

Newport Beach, California, 92663, United States

RECRUITING

San Diego Cardiac Center

San Diego, California, 92123, United States

RECRUITING

California Pacific Medical Center- Sutter Health

San Francisco, California, 94109, United States

WITHDRAWN

Providence Saint John s Health Center

Santa Monica, California, 90404, United States

WITHDRAWN

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

Ascension St. Vincent's

Jacksonville, Florida, 32204, United States

RECRUITING

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

RECRUITING

HCA Florida Mercy Hospital

Miami, Florida, 33133, United States

RECRUITING

NCH Healthcare

Naples, Florida, 34102, United States

RECRUITING

Advent Health Orlando

Orlando, Florida, 32803, United States

RECRUITING

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

RECRUITING

NorthShore University Medical Center

Glenview, Illinois, 60026, United States

RECRUITING

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts General

Boston, Massachusetts, 02114, United States

RECRUITING

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Beaumont Health Systems

Royal Oak, Michigan, 48073, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55414, United States

RECRUITING

Morristown Medical Center

Morristown, New Jersey, 07960, United States

RECRUITING

New Mexico Heart Institute

Albuquerque, New Mexico, 87102, United States

RECRUITING

Mount Sinai School of Medicine

New York, New York, 10029, United States

RECRUITING

New York Presbyterian - Weill Cornell Medical Ctr

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

St Francis Hospital

Roslyn, New York, 11576, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

WakeMed Heart & Vascular

Raleigh, North Carolina, 27610, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

York Hospital

York, Pennsylvania, 17403, United States

RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

RECRUITING

Texas Heart Institute

Houston, Texas, 77030, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Inova Fairfax Medical Campus- Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Royal Adelaide Hospital

Adelaide, 5000, Australia

RECRUITING

Canberra Heart Rhythm

Garran, 2605, Australia

WITHDRAWN

Royal Melbourne Hospital

Parkville, 03052, Australia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Biosense Webster, Inc. Clinical Trial

  Biosense Webster, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

949-789-3919; rshar120@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 12, 2024
• Study Start: June 28, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); US (43)