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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Pulse Field Ablation


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with At least two symptomatic AF episodes within last six months from enrollment. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator | Device: Pulse Field Ablation<br>* PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of early onset Primary Adverse Events | Primary Adverse Events (PAEs) occuring within 7 days of an ablation procedure which uses a circular multi-electrode Pulsed Electrical Field Catheter. (Including atrio-esophageal fistula and PV stenosis occurring greater than seven (7) days post ablation procedure.) | 7 days | 
| Freedom of arrhythmia recurrence | The primary effectiveness endpoint for this study will be freedom from documented asymptomatic and symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL). | 3 - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL Improvement | Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT): defined as improvement in total score at 12M post procedure compared to baseline score. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interventional, Irreversible electroporation, Paroxysmal atrial fibrillation