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

Eligibility 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
• * 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)