Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
Biosense Webster, Inc.
Summary
The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF * Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD) * Willing and capable of providing consent * Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Previously diagnosed with persistent or long-standing persistent AF (more than \[\>\] 7 days in duration) * Previous surgical or catheter ablation…
Interventions
- DevicePulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Locations (7)
- OC MemorialFountain Valley, California
- Community Memorial HospitalVentura, California
- Orlando Health Heart and Vascular InstituteOrlando, Florida
- The Kansas City Heart Rhythm InstituteOverland Park, Kansas
- Texas Cardiac Arrhythmia Research FoundationAustin, Texas
- Winchester Medical CenterWinchester, Virginia