A Prospective Randomized Pivotal Trial of the FARAPULSE Pulsed Field Ablation System Compared With Standard of Care Ablation in Patients With Paroxysmal Atrial Fibrillation

Composite Safety Endpoint;Proportion of MITT Subjects With One or More of the Specified Device or Procedure Related SAEs

时间窗: 7 days and 12 Months

Proportion of Intent to Treat subjects with one or more of the specified device or procedure related SAEs

Primary Effectiveness Endpoint

时间窗: 12-Months

Treatment Success: The primary effectiveness endpoint is Treatment Success in MITT Subjects, defined as: 1. Acute Procedural Success AND 2. Chronic Success, defined as freedom from: 1. At the Index / Rescheduled Index Procedure: Use of a non-randomized treatment modality for PVI 2. After the Blanking Period: i. Occurrence of any Detectable AF, AFL or AT (excluding CTI-dependent flutter confirmed by EP study) ii. Any cardioversion for AF, AFL or AT (excluding for CTI-dependent flutter) iii. Use of any Type I or Type III antiarrhythmic medication for the treatment of AF, AFL or AT c. At any time: i. Re-ablation for AF, AFL or AT (other than for CTI-dependent flutter) ii. Use of amiodarone, except intra-procedurally to control an arrhythmia Endpoint status will be assessed through the Month 12 Assessment (Day 360 ± 30).