NCT07815119Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 590 (estimated)
- First submitted
- 6 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07815119
What you commit to
- Study type: Interventional
- Planned participants: 590
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhognshan Hospital ,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.