NCT07453940

Left Atrial Appendage Closure With Versus Without Pulsed Field Ablation in Atrial Fibrillation Patients With Mild Symptoms 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sir Run Run Shaw Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION
• PFA Ablation and LAAC Procedures

Interventions

Type	Name	Description
PROCEDURE	LAAC plus PFA for persistent AF with high risk of stroke	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.
PROCEDURE	LAAC for persistent AF with high risk of stroke	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-15
• Completion: 2027-01-31
• First posted: 2026-03-06
• Last updated: 2026-03-24

Locations

1 site across 1 country: China