This prospective, multicenter, randomized controlled study was designed to investigate the feasibility, efficacy and safety of pulsed field ablation (PFA) strategies for persistent atrial fibrillation. For patients with persistent atrial fibrillation and normal left atrial substrate, pulmonary vein isolation combined with superior vena cava isolation will be performed. For those with abnormal left atrial substrate, two strategies will be adopted: pulmonary vein isolation plus superior vena cava isolation, and pulmonary vein isolation combined with superior vena cava isolation and left atrial posterior wall isolation. Long-term follow-up will be conducted to observe the long-term clinical outcomes.
Older than 18 years.
Diagnosed as persistent atrial fibrillation (AF); Definition: At least one episode of persistent AF was recorded on dynamic electrocardiogram (ECG) data within 12 months prior to enrollment, or other clinical evidence supporting persistent AF episodes lasting more than 7 days.
Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Atrial fibrillation is secondary to thyroid disease or other reversible factors.
Evidence of left atrial or left atrial appendage thrombus on imaging examination.
Rheumatic heart disease or the presence of moderate to severe mitral stenosis or regurgitation.
Left ventricular ejection fraction <40% or New York Heart Association (NYHA) class III/IV.
Parallel
superior vena cava isolation
Procedure/SurgeryLeft atrial substrate mapping is performed after pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation isolation will be conducted in the experimental group.
Abnormal left atrial substrate
Procedure/SurgeryLeft atrial substrate mapping is performed following pulmonary vein ablation. For patients with abnormal left atrial substrate, superior vena cava isolation will be carried out in the control group.
12-month atrial fibrillation (AF) ablation success rate
Defined as the absence of AF, atrial flutter (AFL), or atrial tachycardia (AT) episodes ≥30 seconds on dynamic electrocardiogram (ECG) monitoring after the blanking period (90 days post-catheter ablation)
Acute pulmonary vein ablation success rate and superior vena cava isolation rate.
Twenty minutes after completion of ablation, under three-dimensional electroanatomical mapping, the ablated area presents as an electrically silent region (voltage \< 0.1 mV). Alternatively, a circular mapping catheter or ablation catheter is positioned within the ablation line: (1) disappearance of intracatheter potentials within the ablation line (entrance block); (2) no local potential capture during pacing of the pulmonary veins and superior vena cava, or local potential capture without subsequent conduction exit (exit block).
Immediate Success Rate of Left Atrial Posterior Wall Ablation (Abnormal Substrate Group Only)
Twenty minutes after completion of ablation, the ablated area presented as an electrically silent zone (voltage \< 0.1 mV) under three-dimensional electroanatomic mapping; no local potential capture was achieved during posterior wall pacing.
Procedure-related time
Total procedure time, catheter manipulation time, pulse discharge time, total fluoroscopy time.
Early recurrence rate of atrial arrhythmia (within the blanking period)
Early recurrence rate of atrial arrhythmia (within the blanking period)
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