NCT07301190 FIH Study of PFLotus in Persistent Atrial Fibrillation

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1\. Aged between 18 and 75 years (inclusive), regardless of gender 2. Diagnosed with symptomatic persistent atrial fibrillation (AF). The patient's medical records document that the duration of AF episodes exceeds 7 days or the patient has a history of persistent AF, and meets \*\*any one\*\* of the following criteria: 1. A 24-hour ambulatory electrocardiogram (Holter) recorded within 365 days prior to enrollment shows AF throughout the monitoring period. 2. Two electrocardiograms (ECGs) obtained at an interval of more than 7 days within 365 days prior to enrollment both demonstrate AF. 3\. Poor response to treatment with at least one class I or class III antiarrhythmic drug (AAD), or intolerance to class I or class III AADs. 4\. Willing to participate in the trial, comply with the follow-up requirements specified in the protocol, and sign the informed consent form. Exclusion Criteria: 1. Paroxysmal atrial fibrillation (AF) 2. AF caused by electrolyte disorders, thy

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