Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion (NCT07313228) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
70 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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;
✕. Left atrial anteroposterior diameter ≥ 55 mm;
✕. Left ventricular ejection fraction (LVEF) ≤ 40%;
What they're measuring
1
No recurrence of atrial arrhythmias within 12 months
Timeframe: 12month
Trial details
NCT IDNCT07313228
SponsorFirst Affiliated Hospital of Ningbo University