Left atrial appendage closure alone or combined with pulsed field ablation for people with persistent atrial fibrillation and high stroke risk

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 will test whether adding pulsed field ablation to left atrial appendage closure helps people with persistent atrial fibrillation who have mild symptoms but are at high risk of stroke.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Run Run Shaw Hospital (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07453940 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-blinded, randomized pilot comparing left atrial appendage closure (LAAC) alone versus LAAC combined with pulsed field ablation (PFA) in 50 patients with persistent AF and elevated stroke risk. Participants are randomized 1:1 and undergo baseline testing including cardiopulmonary exercise testing, the AFEQT quality-of-life survey, and brain MRI, with follow-up to compare clinical and imaging outcomes. Procedures involve percutaneous LAA closure with or without concurrent PFA performed at the coordinating hospital, and group allocation is blinded to participants. The goal is to determine whether the combined approach improves outcomes such as stroke risk markers, AF burden, or heart-failure related events compared with LAAC alone.

Who should consider this trial

Good fit: Adults (≥18) with persistent AF lasting more than three months, mild symptoms (AFEQT >70), a CHA2DS2-VA score of at least 2, and LAA anatomy suitable for device closure are the intended participants.

Not a fit: Patients with reversible causes of AF, prior AF ablation or surgically excluded LAA, very large left atria (anteroposterior ≥5.5 cm), severe heart failure (NYHA III/IV or LVEF ≤35%), or recent major cardiac/neurologic/gastrointestinal events are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, combining PFA with LAAC could reduce stroke risk, lower AF burden, and decrease heart-failure complications compared with LAAC alone.

How similar studies have performed: LAAC is an established option for stroke prevention and PFA is an emerging ablation technology, but combining LAAC and PFA is relatively novel and supported by limited prior evidence.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Subjects diagnosed with persistent AF with duration more than 3 months.
3. Subjects with AFEQT score \>70 .
4. Subjects with CHA2DS2-VA score ≥2.
5. Subjects who are willing and capable of providing ICF and participating in all testing associated with this study.

Exclusion Criteria:

1. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes.
2. Subjects with the history of AF ablation, LAA surgically closed or otherwise excluded or the LAA anatomy does not accommodate a Closure Device.
3. Left atrial anteroposterior diameter ≥ 5.5 cm.
4. Heart failure with a NYHA III/IV and/or LVEF ≤35% within 3 months prior to the procedure.
5. 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
6. Contraindication to, or unwillingness to use systemic anticoagulation.
7. Subjects with contraindications or not tolerate to EP procedure, general anaesthesia, or the tests included in the study, like CPET, MRI.
8. Subjects cannot be removed from Class I/III AAD for reasons other than atrial arrhythmia.
9. Women of childbearing potential who are pregnant or lactating.
10. Renal insufficiency if an eGFR is \< 30 mL/min/1.73 m2, or with any history of renal dialysis or renal transplant.
11. Predicted life expectancy is less than 12 months.

Where this trial is running

Hangzhou, Zhejiang

• Sir Run Run Shaw Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Chenyang Jiang

Conditions ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION; PFA Ablation and LAAC Procedures