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

NCT07815119 | Recruiting

• 2 other identifiers: KY2026155-1B2026-563
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonvalvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Primary outcome: Composite incidence of periprocedural serious safety events

  Number and percentage of participants with at least one of the following events, adjudicated by a blinded independent clinical event committee: cardiovascular death; ischemic or hemorrhagic stroke; systemic embolism; clinically relevant pericardial effusion or cardiac tamponade; or another serious procedure-related complication. Prespecified serious procedure-related complications include device embolization, major vascular complications, acute kidney injury, or bleeding requiring transfusion, interventional treatment, or surgery.

  From the start of the LAAC procedure through 30 days after the procedure

Secondary Outcomes (16)

• Secondary outcome 1: Proportion of participants with clinically relevant peridevice leak of at least 3 mm

  3 months after LAAC (allowed window: plus or minus 2 weeks)

• Secondary outcome 2: Proportion of procedures requiring replacement of the initially selected occluder

  During the LAAC procedure

• Secondary outcome 3: Proportion of participants requiring crossover to the nonassigned preprocedural imaging strategy

  From randomization through completion of preprocedural planning

• Secondary outcome 4: Technical success of left atrial appendage closure

  At completion of the LAAC procedure

• Secondary outcome 5: Incidence of individual components of the primary composite outcome

  From the start of the LAAC procedure through 30 days after the procedure

Study Arms (2)

TEE-Guided Preprocedural Imaging Assessment

ACTIVE COMPARATOR

Before LAAC, left atrial appendage anatomy and procedural planning, including selection of occluder type and size, will be based primarily on transesophageal echocardiography. Use of the nonassigned modality is permitted when clinically necessary and will be recorded. LAAC and postprocedural care otherwise follow standardized routine practice.

Diagnostic Test: Transesophageal Echocardiography-Guided Preprocedural Assessment

CCTA-Guided Preprocedural Imaging Assessment

EXPERIMENTAL

Before LAAC, left atrial appendage anatomy and procedural planning, including selection of occluder type and size, will be based primarily on cardiac computed tomography angiography. Use of the nonassigned modality is permitted when clinically necessary and will be recorded. LAAC and postprocedural care otherwise follow standardized routine practice.

Diagnostic Test: Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment

Interventions

Transesophageal Echocardiography-Guided Preprocedural Assessment DIAGNOSTIC_TEST

TEE is used as the primary preprocedural imaging modality to evaluate left atrial appendage morphology, ostial dimensions, depth, and relationships to adjacent structures and to guide occluder type and size selection.

TEE-Guided Preprocedural Imaging Assessment

Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment DIAGNOSTIC_TEST

CCTA is used as the primary preprocedural imaging modality to evaluate left atrial appendage morphology, three-dimensional anatomy, ostial area, depth, and relationships to adjacent structures and to guide occluder type and size selection.

CCTA-Guided Preprocedural Imaging Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhognshan Hospital ,Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Links

• Galea R, et al. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2022;145:724-738.

Study Officials

• Xiaochun Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Jiang, MD

CONTACT

+86-21-64041990 ext. 613397; jiang.hao2@zs-hospital.sh.cn

Xiaochun Zhang, MD

CONTACT

+86-21-64041990 ext. 612846; zhang.xiaochun1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, treating physicians, and investigators are aware of the assigned preprocedural imaging strategy. Clinical events are adjudicated by an independent committee blinded to randomized assignment. Prespecified imaging endpoints are assessed by an imaging core laboratory blinded to randomized strategy and relevant clinical outcomes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 to a TEE-guided or CCTA-guided preprocedural imaging assessment strategy before LAAC.

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)