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.
A 24-hour ambulatory ECG (Holter) recording demonstrating AF throughout the entire monitoring period.
Two separate standard 12-lead ECGs, taken at least 7 days apart, both confirming AF.
Paroxysmal atrial fibrillation (AF)；
AF caused by electrolyte disorders, thyroid diseases, or reversible/non-cardiac etiologies；
Patients undergoing retreatment after ablation for rapid atrial tachyarrhythmias；
Patients with sustained ventricular tachycardia or ventricular fibrillation；
Single group
Ablation with the PFLotus catheter and Depolar system
DevicePVI and additional ablation strategies-including ablation of the left atrial posterior wall (LAPW), mitral isthmus (MI), cavotricuspid isthmus (CTI), and superior vena cava (SVC)-were performed in all patients with PerAF using the PFLotus PFA catheter and Depolar mapping system.
Incidence of Primary Adverse Events (PAEs) Within 3 Months Post-Ablation [Primary Safety Endpoint]
The primary safety endpoint is defined as the incidence of primary adverse events (PAEs) in patients within 3 months after the index ablation. PAEs include: ① Adverse events occurring within 7 days post-ablation; ② Later-occurring events (device- or procedure-related death, atrio-esophageal fistula, pulmonary vein \[PV\] stenosis); ③ Persistent diaphragmatic paralysis or phrenic nerve palsy at 3 months post-ablation.
Rate of Acute Procedural Success: Complete Pulmonary Vein Isolation and Bidirectional Block at Targeted Linear Ablation Sites [Primary Efficacy Endpoint]
The primary efficacy endpoint is defined as the rate of acute procedural success immediately after the ablation procedure. Acute procedural success is confirmed when patients meet the following criteria: 1. Complete electrical isolation of all pulmonary veins; 2. Bidirectional block verified at all targeted linear ablation sites (including left atrial posterior wall \[LAPW\], mitral isthmus \[MI\], cavotricuspid isthmus \[CTI\], and superior vena cava \[SVC\]) in those undergoing linear ablation.
Rate of Acute Pulmonary Vein (PV) Isolation Success [Secondary Efficacy Endpoint]
Defined as the proportion of participants who achieve complete electrical isolation of all targeted pulmonary veins immediately after the index ablation procedure.
Acute Bidirectional Block Success Rate for Each Targeted Linear Ablation Site [Secondary Efficacy Endpoint]
Defined as the proportion of each targeted linear ablation site (LAPW, MI, CTI, SVC) that achieves verified bidirectional block immediately after the index ablation procedure. Each linear site is assessed independently, and the success rate for each site is reported separately.
Durable Bidirectional Block Success Rate for Each Targeted Linear Ablation Site at 3-Month Remapping [Secondary Efficacy Endpoint]
Defined as the proportion of each targeted linear ablation site (LAPW, MI, CTI, SVC) that maintains verified bidirectional block (without recurrence of conduction) at 3-month remapping after the index ablation procedure. Each linear site is assessed independently, and the durable success rate for each site is reported separately.
1-Year Freedom from Atrial Tachyarrhythmia Recurrence [Secondary Efficacy Endpoint]
Defined as the proportion of participants who remain free from recurrent atrial tachyarrhythmias (including atrial fibrillation, atrial flutter, atrial tachycardia) within 1 year after the index ablation procedure. Recurrence is defined as any episode of atrial tachyarrhythmia lasting ≥30 seconds, confirmed by 12-lead electrocardiogram or 72-hour Holter monitoring, after the 3-month blanking period.
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