About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OMNYPULSE™ Catheter with the TRUPULSE Generator