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

RecruitingNAAges 18 Years - anyAllShanghai Zhongshan Hospital
NCT07815119 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ap

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📋 Eligibility rules (as published)
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.
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What it tests

  • Transesophageal Echocardiography-Guided Preprocedural Assessment
  • Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment
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Where

1 site
Zhognshan Hospital ,Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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