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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator