An interventional study of LAAC plus PFA for persistent AF with high risk of stroke and LAAC for persistent AF with high risk of stroke in ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION and PFA Ablation and LAAC Procedures, sponsored by Sir Run Run Shaw Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment
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.
Sir Run Run Shaw Hospital is the lead sponsor of 123 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any of the following events within 90 days of the Consent Date:
LAAC plus PFA
Procedure: LAAC plus PFA for persistent AF with high risk of stroke
LAAC alone
Procedure: LAAC 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.
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.
Change in peak VO₂ from baseline to 6 months as assessed by CPET
Change in peak oxygen uptake (peak VO₂) measured by cardiopulmonary exercise testing (CPET) at the 6-month visit compared with baseline.
Time frame: 6 months
The change of AFEQT at 6-month visit compared to baseline.
The change of Atrial Fibrillation Effect on QualiTy-of-life questionnaire (AFEQT) at 6-month visit compared to baseline, range: 0-100; higher scores indicate better quality of life
Time frame: 6 months
Symptomatic AF recurrence at 6 month visit after blanking period.
Time frame: 6 months
The change in CBF over 6 months.
Change in cerebral blood flow (CBF) from baseline to 6 months as assessed by arterial spin labeling brain magnetic resonance imaging (MRI)
Time frame: 6 months
The incidence of composite clinical events
The incidence of composite clinical events, including death from cardiovascular causes, stroke (either ischemic or hemorrhagic), major bleeding or hospitalization with worsening of heart failure (unplanned hospitalization and/or intravenous use of diuretics) or acute coronary syndrome.
Time frame: 6 MONTHS
AF burden determined by 7 d Holter during the follow-up visits.
Time frame: 6 MONTHS
Echocardiology parameters
LVEF, LA diameter, left atrial strain (LASr, LASct, LASI)
Time frame: 6 MONTHS
Cognitive function: MoCA scale
Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 6 months, MoCA total score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome will be summarized as the mean change (6-month minus baseline).
Time frame: 6 MONTHS
Actionable AF recurrence rate at 6 months, defined as occurrence of any cardioversion, ablation or AAD treatment for AF post blanking period.
Time frame: 6 MONTHS
The change of Clinical Frailty Scale Health.
The Clinical Frailty Scale (CFS) ranges from 1 to 9, with higher scores indicating worse frailty. The outcome will be summarized as the mean change (6-month minus baseline).
Time frame: 6 MONTHS
The change of NT-proBNP/BNP at 6 month compared to baseline.
Time frame: 6 MONTHS
the imaging assessment
Baseline and 6-month multimodal brain MRI, including three-dimensional T1-weighted imaging (3D T1), T2 fluid-attenuated inversion recovery (T2-FLAIR), with optional diffusion tensor imaging (DTI). DTI is an exploratory imaging endpoint.
Time frame: 6 months
Plan to share: No
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Sir Run Run Shaw Hospital