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

Prior treatment

• Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
• Previous surgical or catheter ablation for AF
• Documented severe dilatation of the left atrium (LAD\>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
• Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction \[MI\] within the past 2 months
• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
• Prior diagnosis of pulmonary vein stenosis
• Current enrollment in an investigational study evaluating another device or drug

Other illness

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• 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)
• 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
• Acute illness, active systemic infection, or sepsis
• 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

Lab values

• Documented severely compromised left ventricular ejection fraction (LVEF \<40%) by imaging within 6 months prior to enrollment

Age

• 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

Other

• Patients known to require ablation outside the PV ostia and outside the CTI region.
• Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
• Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Pre-existing hemi diaphragmatic paralysis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
• Severe mitral regurgitation
• 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)

• 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