Pulse field ablation (PFA) has shown safety and efficacy in paroxysmal atrial fibrillation (AF), while the application in persistent atrial fibrillation (PerAF) is still under investigation. The investigators' previous randomized controlled trial showed favorable outcomes with electrogram (EGM) guided radiofrequency ablation in PerAF. However, EGM-guided PFA has not yet been reported.
Multiple studies have confirmed that pulse field ablation (PFA) demonstrates superior safety and efficacy in pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF). However, the application of PFA in persistent atrial fibrillation (PerAF) remains in the exploratory stages. The efficacy and safety of PFA across various ablation strategies require a comprehensive evaluation. Notably, electrogram (EGM) guided PFA ablation for persistent atrial fibrillation has not yet been reported in the literature. In the investigators' previous study on radiofrequency ablation for PerAF, the investigators observed that EGM guided ablation yielded a high success rate. Furthermore, the investigators' recent research has confirmed that intraoperative termination of atrial fibrillation using EGM guided ablation is associated with favorable long-term outcomes in patients with PerAF. The investigators aim to explore the preliminary application of EGM guided pulse field ablation (PFA) in persistent atrial fibrillation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
In persistent atrial fibrillation patients, traget electrogram was mapped firstly , pulse field ablation of pulmonary veins, posterior wall of left atrium and target electrogram was ablated, until the atrial fibrillation converted to sinus rythm or stable atrial tachycardia. The mapping and ablation procedure was repeated until AF terminated or no target electrogram was found.
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
freedom from any AF/AT
The feasibility primary endpoint was defined as freedom from any AF/AT episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 3 months, 6 months and 12 months respectively after the procedure.
Time frame: freedom from any AF/AT at 3 months, 6 months and 12 months respectively after the procedure; adverse events occurring within 30 days of the index or reassessment procedures.
composite of major safety events
The safety endpoint is a composite of major safety events including cardiac tamponade or perforation, peripheral or organ thromboembolism, stroke or transient ischemic attack (TIA), diaphragmatic paralysis, block, pericarditis, hemolysis, myocardial infarction, PV stenosis, atrioesophageal fistula, and death. The endpoint includes events occurring within 30 days of the index or reassessment procedures.
Time frame: adverse events occurring within 30 days of the index or reassessment procedures.
AF recurrence;
freedom from any documented AF episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months and 12 months respectively
Time frame: freedom from any AF at 3 months, 6 months and 12 months respectively after the procedure;
AT recurrence
Secondary outcomes included: any documented AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drug treatment at 3 months, 6 months and 12 months respectively.
Time frame: freedom from any AT at 3 months, 6 months and 12 months respectively after the procedure;
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