PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation

This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical). The primary study objectives are to determine: * The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint). * The clinical effectiveness of the integrated PFA and mapping system. * The ability of the novel PFA system to produce durable ablation lesions. PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance. Participants will: 1. Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia; 2. Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure; 3. Undergo repeat electrophysiological mapping at 3 months to assess lesion durability; 4. Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.

NCT Number	NCT07321002
Lead Sponsor	The Third People's Hospital of Chengdu
Conditions	Persistent Atrial Fibrillation
Enrollment	35 participants
Start Date	2025-12-22
Primary Completion	2026-06-01 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-06