AdmIRE: Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator |
Device: Pulse Field Ablation
PFA ablation using a circular multi-electrode pulsed electrical field catheter and multichannel generator
|
Outcome Measures
Primary Outcome Measures
- Incidence of early onset Primary Adverse Events [7 days]
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.)
- Freedom of arrhythmia recurrence [3 - 12 months]
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).
Secondary Outcome Measures
- QOL Improvement [12 months]
Atrial Fibrillation Effect on Quality-of-Life Questionnaire (AFEQT): defined as improvement in total score at 12M post procedure compared to baseline score.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
- Diagnosed with Symptomatic Paroxysmal Atrial Fibrillation with
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At least two symptomatic AF episodes within last six months from enrollment.
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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:
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Previously diagnosed with persistent AF (> 7 days in duration).
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AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
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Previous surgical or catheter ablation for AF.
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Patients known to require ablation outside the PV region
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Documented severe dilatation of the LA (LAD >50mm) antero-posterior diameter on imaging within 6 months prior to enrollment.
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Documented LA thrombus by imaging within 48 hours of the procedure.
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Documented severely compromised LVEF (<40%) by imaging within 6 months prior to enrollment
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Uncontrolled heart failure or New York Heart Association Class III or IV
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History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran),
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Documented thromboembolic event (including TIA) within the past 12 months
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Previous PCI/MI within the past 2 months
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Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months (180 days)
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Valvular cardiac surgical/percutaneous procedure
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Unstable angina within 6 months
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Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months.
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Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms.
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Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
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Prior diagnosis of pulmonary vein stenosis
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Pre-existing hemi diaphragmatic paralysis
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Acute illness, active systemic infection, or sepsis
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Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
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Severe mitral regurgitation
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Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE energy field.
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Presence of a condition that precludes vascular access
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Current enrollment in an investigational study evaluating another device or drug.
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Women who are pregnant, lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation.
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Life expectancy less than 12 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arrhythmia Research Group (St. Bernards) | Jonesboro | Arkansas | United States | 72401 |
| 2 | Memorial Health University Medical Center | Savannah | Georgia | United States | 31404 |
| 3 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 4 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 5 | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | United States | 78705 |
Sponsors and Collaborators
- Biosense Webster, Inc.
Investigators
- Study Director: Biosense Webster Inc. Clinical Trial, Biosense Webster, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BWI201910