A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF)
NCT ID: NCT06455098
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
440 participants
INTERVENTIONAL
2024-06-28
2026-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pulsed Field (PF) Ablation System
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.
OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.
Interventions
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OMNYPULSE™ Catheter with the TRUPULSE Generator
OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Biosense Webster, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Biosense Webster, Inc.
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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BWI202303
Identifier Type: OTHER
Identifier Source: secondary_id
BWI202303
Identifier Type: -
Identifier Source: org_study_id