NCT07815119 TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
| NCT ID | NCT07815119 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Nonvalvular Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 590 participants in total. It began in 2026-09-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xiaochun Zhang
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT07815119 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nonvalvular Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07815119 currently recruiting?
Yes, NCT07815119 is actively recruiting participants. Contact the research team at jiang.hao2@zs-hospital.sh.cn for enrollment information.
Where is the NCT07815119 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07815119 clinical trial?
NCT07815119 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Xiaochun Zhang at Fudan University. The trial plans to enroll 590 participants.
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