This clinical trial aims to evaluate the safety and effectiveness of pulmonary vein isolation (PVI) and linear ablation using a large-focal pulsed field ablation (PFA) catheter in patients with persistent atrial fibrillation (perAF). The study will address two primary questions:
1. Is the procedure safe, as determined by the absence of serious device- or procedure-related adverse events within 7 days post-ablation?
2. Is the catheter effective in creating durable lesions, as assessed by invasive electrophysiological remapping?
Study Design and Intervention
Eligible patients with perAF underwent PVI and linear ablation under general anesthesia using the PFApple large-focal PFA catheter. The catheter delivers a biphasic, bipolar pulsed electric field (1000V, 0.04 ms pulse duration) to create spherical ablation lesions.
Participant Follow-up Protocol
Enrolled participants will complete the following assessments:
1. Index Procedure: PVI and linear ablation with the PFApple PFA catheter.
2. Durability Assessment: Repeat invasive electrophysiological remapping at 3 months post-ablation to evaluate lesion durability.
3. Clinical Follow-up: Scheduled visits at 7 days, 30 days, 3 months, 6 months, and 12 months post-procedure. Atrial tachyarrhythmia recurrence is assessed via 12-lead electrocardiography at each visit and 24-hour or 7-day Holter monitoring at the 6- and 12-month time points.