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TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure

Sponsor: Shanghai Zhongshan Hospital • ClinicalTrials.gov ID: NCT07815119

Registry updated: 2026-09-11

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Description

This prospective, open-label, multicenter randomized controlled trial will compare two preprocedural imaging assessment strategies in adults with nonvalvular atrial fibrillation who are scheduled to undergo percutaneous left atrial appendage closure (LAAC). Participants will be randomized 1:1 to a transesophageal echocardiography (TEE)-guided strategy or a cardiac computed tomography angiography (CCTA)-guided strategy for assessment of left atrial appendage anatomy and selection of the occluder type and size. LAAC and postprocedural management will otherwise follow routine clinical practice. The primary outcome is a composite of serious periprocedural safety events through 30 days. At 3 months (plus or minus 2 weeks), participants who undergo LAAC will receive both TEE and CCTA for blinded core-laboratory assessment of peridevice leak, device-related thrombus, and residual left atrial appendage patency. Clinical follow-up will continue through 12 months.

Interventions

Transesophageal Echocardiography-Guided Preprocedural Assessment (Diagnostic test)
TEE is used as the primary preprocedural imaging modality to evaluate left atrial appendage morphology, ostial dimensions, depth, and relationships to adjacent structures and to guide occluder type and size selection.
Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment (Diagnostic test)
CCTA is used as the primary preprocedural imaging modality to evaluate left atrial appendage morphology, three-dimensional anatomy, ostial area, depth, and relationships to adjacent structures and to guide occluder type and size selection.

Eligibility criteria

Inclusion Criteria: * 1\. Age 18 years or older. 2. Diagnosis of nonvalvular atrial fibrillation, including paroxysmal, persistent, or permanent atrial fibrillation. 3\. Planned percutaneous left atrial appendage closure for stroke prevention and considered by the investigator to meet an accepted indication for LAAC. 4\. Able to complete randomization and the assigned preprocedural imaging assessment. 5\. Expected to be able to complete paired TEE and CCTA follow-up at 3 months after LAAC. 6\. Able to complete protocol-specified clinical follow-up. 7. Written informed consent provided by the participant. Exclusion Criteria: * 1\. Atrial fibrillation with moderate or severe mitral stenosis or a history of mechanical valve replacement. 2\. Contraindication to TEE, such as severe esophageal disease or inability to tolerate the procedure. 3\. Contraindication to CCTA, such as severe renal dysfunction or a known allergy to iodinated contrast that cannot be adequately premedicated. 4\. Another established indication for long-term full-dose anticoagulation, such as a mechanical valve or active venous thromboembolism. 5\. Life expectancy shorter than 1 year or a severe noncardiovascular disease that may prevent completion of follow-up or reliable assessment of clinical events. 6\. Pregnancy or breastfeeding. 7. Any other condition that, in the investigator's judgment, makes participation inappropriate.

Conditions

Nonvalvular Atrial Fibrillation

Locations

Zhognshan Hospital ,Fudan University — Shanghai, Shanghai Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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