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RECRUITING
NCT07815119
NA

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Periprocedural and Early Outcomes of Left Atrial Appendage Closure According to Preprocedural Imaging Assessment Strategies: A Prospective Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

590

Start Date

2026-09-01

Completion Date

2029-09-01

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Transesophageal Echocardiography-Guided Preprocedural Assessment

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.

DIAGNOSTIC_TEST

Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment

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.

Locations (1)

Zhognshan Hospital ,Fudan University

Shanghai, Shanghai Municipality, China