Status:

RECRUITING

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

Lead Sponsor:

Biosense Webster, Inc.

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18-80 years

Phase:

NA

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 part...

Eligibility Criteria

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)

Key Trial Info

Start Date :

June 28 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2026

Estimated Enrollment :

440 Patients enrolled

Trial Details

Trial ID

NCT06455098

Start Date

June 28 2024

End Date

June 30 2026

Last Update

March 13 2026

Active Locations (46)

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Page 1 of 12 (46 locations)

1

Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States, 85018

2

Mills Peninsula Health Services

Burlingame, California, United States, 94010

3

Scripps Clinic/Prebys Cardiovascular Institute

La Jolla, California, United States, 92037

4

Cardiovascular Associates of Marin

Larkspur, California, United States, 94939