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

Recruiting now · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT06455098

Run by

Biosense Webster, Inc.

People needed

440

Starts

2024-06-28

Expected to finish

2026-06-30

Last updated by the study team

2026-03-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Royal Melbourne Hospital — Parkville, Australia (enrolling)
• Mills Peninsula Health Services — Burlingame, California, United States (enrolling)
• Inova Fairfax Medical Campus- Inova Heart and Vascular Institute — Falls Church, Virginia, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)
• Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
• Royal Adelaide Hospital — Adelaide, Australia (enrolling)
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States (enrolling)
• Cardiovascular Associates of Marin — Larkspur, California, United States (enrolling)
• Hoag Memorial Hospital — Newport Beach, California, United States (enrolling)
• San Diego Cardiac Center — San Diego, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Ascension St. Vincent's — Jacksonville, Florida, United States (enrolling)
• Baptist Health Research Institute — Jacksonville, Florida, United States (enrolling)
• HCA Florida Mercy Hospital — Miami, Florida, United States (enrolling)
• NCH Healthcare — Naples, Florida, United States (enrolling)
• Advent Health Orlando — Orlando, Florida, United States (enrolling)
• Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
• Emory Saint Joseph's Hospital — Atlanta, Georgia, United States (enrolling)
• Northside Hospital — Atlanta, Georgia, United States (enrolling)
• Memorial Health University Medical Center — Savannah, Georgia, United States (enrolling)
• NorthShore University Medical Center — Glenview, Illinois, United States (enrolling)
• Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Massachusetts General — Boston, Massachusetts, United States (enrolling)
• Brigham And Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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