Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
Biosense Webster, Inc.
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.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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, thy…