Single-shot pulsed-field ablation (PFA) catheters maximize pulmonary vein isolation (PVI) efficiency but are limited for focal or linear ablation. The goal of this clinical trial is to evaluate the safety and effectiveness of a novel, PFA catheter that transitions between large 'petals' (single-shot), and a small, spherical 'bud' (large-focal/linear), enabling a PVI-plus strategy in patients with persistent AF (PersAF). The main questions it aims to answer are: 1. Is there an absence of serious procedure or device-related adverse events within 7 days? 2. Can the catheter achieve durable lesions? This trial enrolled patients with perAF , who were treated under general anesthesia with the shape-adaptive PFA catheter (PFLotus, bipolar, biphasic, 850 V, 60 μs, EnChannel Medical). Participants will: 1. Undergo PVI and linear ablation with the PFLotus PFA catheter under general anesthesia; 2. Undergo remapping within 3-month post the index ablation to assess the durability of the lesions; 3. Undergo follow-up occurred at 7 days, 30 days, 3, 6, and 12 months. Recurrence was assessed via 12-lead ECG at each visit and 24-hour or 7-day Holter monitoring at 6 and 12 months.
Age range
18 Years – 75 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
The primary safety endpoint
Timeframe: Seven days post index ablation procedure
The primary efficacy endpoint
Timeframe: Immediately after the index ablation procedure