This is a single-center, prospective, single-arm clinical trial designed to evaluate the safety and efficacy of pulsed field ablation (PFA) after left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). The trial will include patients who have undergone successful LAAO and have symptomatic AF that is refractory to or intolerant of class I or III antiarrhythmic drugs. The primary objective is to assess the effectiveness of PFA in preventing AF recurrence and its safety, including the occurrence of serious adverse events. Patients will be followed up for 12 months post-procedure to evaluate outcomes such as recurrence of AF, complications, and device-related issues.
Aged 18-75 years;
Documented symptomatic atrial fibrillation;
Ineffective or intolerant to at least one class I or III antiarrhythmic drug;
Able to fully understand the treatment protocol, voluntarily sign the informed consent form, and willing to undergo the required examinations, procedures, and follow-up.
Patients who have previously undergone left atrial surgery;
Left atrial thrombus;
Patients with pulmonary agenesis;
Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
The selected population consists of adult patients with a documented history of atrial fibrillation who have undergone left atrial appendage occlusion and are planned to undergo pulsed field ablation due to ineffective drug treatment. Additionally, they must not have any surgical contraindications.
Case-only
Prospective
Pulsed Field Ablation
Procedure/SurgeryPulsed Field Ablation is a surgical technique for atrial fibrillation ablation that uses pulsed electric fields.
No recurrence of atrial arrhythmias within 12 months
Defined as the absence of such arrhythmias in the efficacy evaluation period (from blanking period to the end of 12-month follow-up) based on ECG data (including both surface ECG and 24-hour Holter monitoring).
Ablation success
Defined as the maintenance of electrical isolation of the pulmonary veins, regardless of whether isoproterenol is used, after programmed stimulation.
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