Left atrial appendage closure with or without pulsed field ablation in persistent atrial fibrillation
Compares closing the left atrial appendage alone versus with pulsed field ablation, in adults.
Plain-language title generated from the registry record
Registry title: Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms and High Stroke Risk
Key facts
- Where
- Hangzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-lasting (persistent) atrial fibrillation, mild symptoms and a high risk of stroke. It compares closing the left atrial appendage with or without pulsed field ablation.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Persistent atrial fibrillation lasting more than 3 months, with an AFEQT score above 70 (mild symptoms) and a CHA2DS2-VA score of 2 or more.
- Earlier treatment
- People who have had a past AF ablation, or whose left atrial appendage was already closed or cannot take a closure device, cannot join. People who cannot stop certain heart rhythm drugs (Class I/III) for reasons other than atrial arrhythmia cannot join.
Main reasons for not taking part
- AF caused by a reversible or non-heart problem such as thyroid disease or alcohol
- Left atrial anteroposterior diameter of 5.5 cm (2.2 in) or more
- Heart failure with NYHA III/IV and/or LVEF of 35% or less within 3 months before the procedure
- Heart attack, stroke, bleeding or cardiac surgery within 90 days of consent
- Kidney problems with eGFR below 30 mL/min/1.73 m2, or any history of dialysis or kidney transplant
Read by machine on 9 November 2026.
Where in China
- Sir Run Run Shaw HospitalHangzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sir Run Run Shaw Hospital
- Trial code
- NCT07453940
- Record updated
- 1 July 2026
- Original description
This study is a prospective, multicenter, single-blinded, randomized controlled trial to investigate whether concomitant left atrial appendage closure (LAAC) and pulsed field ablation (PFA) is more effective than LAAC alone in improving the outcomes in persistent atrial fibrillation (AF) patients with high risk of stroke.Read full original descriptionShow less
Left Atrial Appendage Closure and Pulsed Field Ablation Procedure Versus Left Atrial Appendage Closure Alone in Persistent Atrial Fibrillation Patients With Mild Symptoms and High Risk of Stroke: A Prospective, Multicenter, Single-Blind, Randomized Controlled Pilot Study
This study is a prospective, multicenter, single-blinded, randomized controlled trial to investigate whether concomitant left atrial appendage closure (LAAC) and pulsed field ablation (PFA) is more effective than LAAC alone in improving the outcomes in persistent atrial fibrillation (AF) patients with high risk of stroke.
Emerging data show that some-especially those with persistent AF, high AF burden, or early atrial re-modelling-have high stroke and heart failure risks. This pilot study aims to assess whether combining LAAC and PFA improves outcomes more than LAAC alone in persistent AF patients at high stroke risk. Fifty participants will be randomly assigned in a 1:1 ratio to the LAAC or LAAC plus PFA group, with group allocation blinded.
Baseline assessments included cardiopulmonary exercise testing (CPET), the Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT) , and brain magnetic resonance imaging (MRI). In the LAAC group, patients will undergo electrical cardioversion followed by LAAC under general anesthesia; if sinus rhythm could not be achieved by the end of procedure, pharmocol cardioversion will be tried to restore it. In the LAAC plus PFA group, pulmonary vein isolation (PVI) and posterior wall isolation (PWI) will be performed using the FARAPULSE system, then LAAC will be done. If sinus rhythm could not be restored after PFA, cardioversion will be performed. Additional ablation is allowed only if a clear arrhythmia mechanism is identified; empirical ablation is prohibited. Follow-up occurs every two months with 7-day Holter monitoring. CPET, AFEQT, and brain MRI will be repeated at 6 months. During the blanking period, antiarrhythmic drugs may be used except amiodarone due to its long half-life. Ablation is not recommended within the first two months. Crossover to ablation is permitted only for patients with documented AF/AFL/AT recurrence and worsened symptoms (AFEQT score drop ≥10 points from baseline). At crossover or redo-ablation, AFEQT, CPET, and brain MRI will be repeated.
Inclusion: Age ≥ 18 years old; Subjects diagnosed with persistent AF with duration more than 3 months; Subjects with AFEQT score >70 ; Subjects with CHA2DS2-VA score ≥2; Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.
Exclusion: AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes; Subjects with the history of AF ablation, LAA surgically closed or otherwise excluded or the LAA anatomy does not accommodate a Closure Device; Any of the following events within 90 days of the Consent Date:; Myocardial infarction, unstable angina or coronary intervention or any cardiac surgery; Pericarditis or symptomatic pericardial effusion; Gastrointestinal bleeding; Stroke, TIA, or intracranial bleeding or any non-neurologic thromboembolic event; Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia; Heart failure with a NYHA III/IV and/or LVEF ≤35% within 3 months prior to the procedure; Renal insufficiency if an eGFR is < 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant; Left atrial anteroposterior diameter ≥ 5.5 cm; Contraindication to, or unwillingness to use systemic anticoagulation; Subjects with contraindications or not tolerate to EP procedure, general anaesthesia, or the tests included in the study, like CPET, MRI; Women of childbearing potential who are pregnant or lactating; Predicted life expectancy is less than 12 months.