Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter
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.
• 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