About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Pulsed Field Ablation