Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System

Exclusion Criteria

• •Previously diagnosed with persistent AF (\> 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 region
• •Documented severe dilatation of the LA (LAD \>50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
• •Documented LA thrombus by imaging within 48 hours of the procedure.
• •Documented severely compromised LVEF (\<40%) by imaging within 6 months prior to enrollment
• •Uncontrolled heart failure or New York Heart Association Class III or IV
• •History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
• •Documented thromboembolic event (including TIA) within the past 12 months
• •Previous PCI/MI within the past 2 months
• •Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
• •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 implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE 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, 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