A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Purpose
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).
Condition
- Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 22 Years
- Eligible Sex
- All
- Accepts 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 for AF - Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF - Current enrollment in an investigational study evaluating another device or drug - Life expectancy less than 12 months - Any contraindications as defined in the Protocol
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator |
Participants undergoing electrophysiology mapping and pulsed field ablation (PFA) for management of treatment of symptomatic paroxysmal atrial fibrillation (AF) will undergo pulmonary vein (PV) ablation with the VARIPULSE Catheter with a TRUPULSE Generator. |
|
Recruiting Locations
Phoenix Cardiovascular Research Group
Phoenix, Arizona 85018
Phoenix, Arizona 85018
Tucson Medical Center Pima Heart and Vascular
Tucson, Arizona 85704
Tucson, Arizona 85704
OC Memorial
Fountain Valley, California 92708
Fountain Valley, California 92708
Community Memorial Hospital
Ventura, California 93003
Ventura, California 93003
Aurora Denver Cardiology Associates
Aurora, Colorado 80012
Aurora, Colorado 80012
Orlando Health Heart and Vascular Institute
Orlando, Florida 32806
Orlando, Florida 32806
The Kansas City Heart Rhythm Institute
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Trinity Health
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Albert Einstein College Of Medicine - Montefiore Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
Springfield Medical Center
Springfield, Ohio 45504
Springfield, Ohio 45504
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
Austin, Texas 78705
Baylor Scott and White Research Institute
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Winchester Medical Center
Winchester, Virginia 22601
Winchester, Virginia 22601
Mercy Hospital
Janesville, Wisconsin 53548
Janesville, Wisconsin 53548
More Details
- Status
- Recruiting
- Sponsor
- Biosense Webster, Inc.