Comparing Two Heart Scans Before Left Atrial Appendage Closure in Atrial Fibrillation
Compares two scan types before appendage closure in adults with nonvalvular atrial fibrillation.
Plain-language title generated from the registry record
Registry title: TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Zhognshan Hospital ,Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT07815119
- Record updated
- 11 September 2026
- Original description
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.Read full original descriptionShow less
Periprocedural and Early Outcomes of Left Atrial Appendage Closure According to Preprocedural Imaging Assessment Strategies: A Prospective Multicenter Randomized Controlled Trial
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.
Inclusion: 1. Age 18 years or older. 2. Diagnosis of nonvalvular atrial fibrillation, including paroxysmal, persistent, or permanent atrial fibrillation; Planned percutaneous left atrial appendage closure for stroke prevention and considered by the investigator to meet an accepted indication for LAAC; Able to complete randomization and the assigned preprocedural imaging assessment; Expected to be able to complete paired TEE and CCTA follow-up at 3 months after LAAC; Able to complete protocol-specified clinical follow-up. 7. Written informed consent provided by the participant.
Exclusion: 1. Atrial fibrillation with moderate or severe mitral stenosis or a history of mechanical valve replacement; Contraindication to TEE, such as severe esophageal disease or inability to tolerate the procedure; Contraindication to CCTA, such as severe renal dysfunction or a known allergy to iodinated contrast that cannot be adequately premedicated; Another established indication for long-term full-dose anticoagulation, such as a mechanical valve or active venous thromboembolism; Life expectancy shorter than 1 year or a severe noncardiovascular disease that may prevent completion of follow-up or reliable assessment of clinical events; Pregnancy or breastfeeding. 7. Any other condition that, in the investigator's judgment, makes participation inappropriate.