Status:
COMPLETED
Assessment of Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the BWI IRE Ablation System
Lead Sponsor:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 wi...
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 refract...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT05293639
Start Date
April 18 2022
End Date
December 11 2023
Last Update
May 25 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Grandview Medical Center
Birmingham, Alabama, United States, 35243
2
Phoenix Cardiovascular Research
Phoenix, Arizona, United States, 85016
3
Arrhythmia Research Group (St. Bernards)
Jonesboro, Arkansas, United States, 72401
4
Cardiovascular Group of Marin/SF Med Group
Larkspur, California, United States, 94904