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

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

To demonstrate the safety and 12-month effectiveness of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator for pulmonary vein isolation (PVI) in the treatment of subjects with symptomatic paroxysmal atrial fibrillation.

This is a prospective, non-randomized, multi-center, clinical evaluation of the Biosense Webster IRE Ablation system to demonstrate safety and long-term effectiveness for the treatment of drug refractory symptomatic PAF. The BWI IRE Ablation System consists of the VARIPULSE™ Catheter and TRUPULSE™ Generator. In conjunction with CARTO™ 3 system, it is indicated for PVI of patients with drug refractory paroxysmal atrial fibrillation.

Key Inclusion Criteria:

• Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with

  1. At least two symptomatic AF episodes within last six months from enrollment.
  2. At least one ectrocardiographically documented AF episode within twelve (12) months prior to enrollment.

• Failed at least one Class I or Class III antiarrhythmic drug.

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