A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System

BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System

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).

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