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

Launched by BIOSENSE WEBSTER, INC. · Mar 15, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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