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

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 twelvemonths 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 andrequirements

Exclusion Criteria:

• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiaccause.

• 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-posteriordiameter 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%) byimaging 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 toanticoagulation (heparin, warfarin, or dabigatran)

• Documented thromboembolic event (including transient ischemic attack or TIA) withinthe past 6 months

• Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] withinthe 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 withinthe next 12 months

• Significant pulmonary disease or any other disease or malfunction of the lungs orrespiratory system that produces severe chronic symptoms

• Significant congenital anomaly or medical problem that in the opinion of theinvestigator 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 orother 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 mayinterfere 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 thecourse of the clinical investigation

• Life expectancy less than 12 months

• Presenting contra-indications for the devices used in the study, as indicated in therespective Instructions for Use (IFU)