NCT07313228Not yet recruiting
Pulsed Field Ablation for Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion
Pulsed Field Ablation of Non-valvular Atrial Fibrillation After Left Atrial Appendage Occlusion: A Prospective, Single-center, Single-arm Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 17 Dec 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital of Ningbo University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07313228
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Dec 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have previously undergone left atrial surgery;
- Patients who have previously undergone interatrial septal repair or removal of atrial myxoma;
- Patients who have participated or are currently participating in another clinical trial within the past 12 months prior to enrollment;
Other illness
- Patients with NYHA heart failure class III-IV;
- Patients with a clear history of cerebrovascular disease (including cerebral hemorrhage, stroke, or TIA) within the past 6 months;
- Patients who have experienced cardiovascular events (e.g., acute myocardial infarction, coronary intervention or bypass surgery, valve replacement or repair, atrial or ventricular surgery) within the past 3 months;
- Patients with acute or severe systemic infections;
- Patients with severe liver or kidney disease, malignancy, or end-stage disease that may affect the treatment, assessment, or compliance of the trial (as judged by the investigator);
- Patients with significant bleeding tendency, hypercoagulable state, or severe hematologic disorders;
Lab values
- Left ventricular ejection fraction (LVEF) ≤ 40%;
Age
- Female patients of reproductive age who cannot use effective contraception within 12 months after enrollment;
Other
- Left atrial thrombus;
- Patients with pulmonary agenesis;
- Left atrial anteroposterior diameter ≥ 55 mm;
- Patients with active implanted devices (e.g., pacemaker, ICD);
- Patients who the investigator deems unsuitable for participation in this trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All
This page is information, not medical advice. Discuss any trial with your doctor.