RecruitingAtrial Fibrillation

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

Eligible age

18–80 yrs

Accepts

All genders

Locations

20 states

Healthy volunteers

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About this study

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.

Sponsor: Biosense Webster, Inc.

You may qualify if…

✓ 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

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