RECRUITINGINTERVENTIONAL
A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System
Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator
Pulsed field ablation by VARIPULSE catheter with TRUPULSE generator will be used.
Locations (7)
OC Memorial
Fountain Valley, California, United States
Community Memorial Hospital
Ventura, California, United States
Orlando Health Heart and Vascular Institute
Orlando, Florida, United States
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Winchester Medical Center
Winchester, Virginia, United States
Mercy Hospital
Janesville, Wisconsin, United States