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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter randomized trial enrolling adults with nonvalvular atrial fibrillation planned for percutaneous left atrial appendage closure. Participants are randomized 1:1 to either a TEE-guided or a CCTA-guided strategy to assess left atrial appendage anatomy and select occluder type and size, with routine postprocedural care otherwise. The study includes an embedded paired-imaging component where both imaging modalities are performed at 3 months for blinded assessment of peridevice leak, device-related thrombus, and residual appendage patency. The primary endpoint is a composite of serious periprocedural safety events through 30 days; follow-up extends to 12 months. Imaging outcomes are adjudicated by blinded core laboratories and an independent event committee.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhognshan Hospital ,Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaochun Zhang — Fudan University
• Study coordinator: Hao Jiang, MD
• Email: jiang.hao2@zs-hospital.sh.cn
• Phone: +86-21-64041990 ext. 613397

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.