RecruitingNot ApplicableNCT07815119

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

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


Sponsor

Shanghai Zhongshan Hospital

Enrollment

590 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment and Transesophageal Echocardiography-Guided Preprocedural Assessment for people with nonvalvular atrial fibrillation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTransesophageal 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_TESTCardiac 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

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NCT07815119


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