TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure (PEARL-LAAC)

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.

Study Overview

• Status: Recruiting
• Conditions: Nonvalvular Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Transesophageal Echocardiography-Guided Preprocedural Assessment; Diagnostic test: Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment

Detailed Description

Eligible participants will be adults with nonvalvular atrial fibrillation for whom LAAC is planned for stroke prevention. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio through a centralized electronic system using center-stratified, variable-block randomization.

In the TEE-guided group, preprocedural planning will be based primarily on TEE measurements of left atrial appendage morphology, ostial dimensions, depth, and adjacent structures. In the CCTA-guided group, planning will be based primarily on CCTA assessment of morphology, three-dimensional anatomy, ostial area, depth, and adjacent structures. In both groups, the assigned modality will guide occluder type and size selection. Use of the nonassigned modality when clinically necessary will be documented. The indication for LAAC, the procedure itself, intraprocedural imaging, and postprocedural management will follow standardized routine care.

The trial has two linked components. The randomized strategy comparison evaluates procedural performance and early clinical safety. An embedded paired-imaging study will compare TEE and CCTA within the same participant at 3 months after LAAC. Clinical events will be adjudicated by an independent clinical event committee blinded to randomized assignment. Prespecified imaging outcomes will be assessed by a blinded imaging core laboratory. Follow-up visits are planned before discharge and at 3, 6, and 12 months after LAAC.

• Study Type: Interventional
• Enrollment (Estimated): 590
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hao Jiang, MD; Phone Number: +86-21-64041990 ext. 613397; Email: jiang.hao2@zs-hospital.sh.cn
• Study Contact Backup: Name: Xiaochun Zhang, MD; Phone Number: +86-21-64041990 ext. 612846; Email: zhang.xiaochun1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhognshan Hospital ,Fudan University
      • Contact: Xiaochun Zhang, MD; Phone Number: +86-21-64041990 ext. 612846; Email: zhang.xiaochun1@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TEE-Guided Preprocedural Imaging Assessment; 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; 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.
Experimental: CCTA-Guided Preprocedural Imaging Assessment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome 1: Proportion of participants with clinically relevant peridevice leak of at least 3 mm	Maximum peridevice leak width will be measured separately by TEE and CCTA and adjudicated by the blinded imaging core laboratory. The proportion of participants with a maximum width of at least 3 mm will be reported for each modality and compared within participants.	3 months after LAAC (allowed window: plus or minus 2 weeks)
Secondary outcome 2: Proportion of procedures requiring replacement of the initially selected occluder	Number and percentage of LAAC procedures in which the initially selected occluder is replaced because of inappropriate size, inability to achieve stable release, or another recorded procedural reason.	During the LAAC procedure
Secondary outcome 3: Proportion of participants requiring crossover to the nonassigned preprocedural imaging strategy	Number and percentage of participants for whom the nonassigned imaging modality is used as a principal basis for preprocedural planning after randomization. The reason for crossover will be recorded.	From randomization through completion of preprocedural planning
Secondary outcome 4: Technical success of left atrial appendage closure	Number and percentage of participants in whom the occluder is successfully released within the left atrial appendage, is not immediately removed, and is stable at completion of the procedure.	At completion of the LAAC procedure
Secondary outcome 5: Incidence of individual components of the primary composite outcome	Each component will be reported separately: cardiovascular death, ischemic stroke, hemorrhagic stroke, systemic embolism, clinically relevant pericardial effusion, cardiac tamponade, device embolization, major vascular complication, acute kidney injury, and bleeding requiring transfusion, interventional treatment, or surgery.	From the start of the LAAC procedure through 30 days after the procedure
Secondary outcome 6: Proportion of participants with device-related thrombus	Number and percentage of participants with device-related thrombus detected by TEE or CCTA and confirmed by the blinded imaging core laboratory.	3 months after LAAC (allowed window: plus or minus 2 weeks)
Secondary outcome 7: Proportion of participants with residual left atrial appendage patency	Number and percentage of participants with residual left atrial appendage patency detected by TEE or CCTA and confirmed by the blinded imaging core laboratory.	3 months after LAAC (allowed window: plus or minus 2 weeks)
Secondary outcome 8: Paired agreement and disagreement between TEE and CCTA for key imaging abnormalities	Within-participant comparison of TEE and CCTA for device-related thrombus, peridevice leak of at least 3 mm, and residual left atrial appendage patency. Discordant proportions will be compared using McNemar tests and agreement will be summarized using kappa statistics.	3 months after LAAC (allowed window: plus or minus 2 weeks)
Secondary outcome 9: Cumulative incidence of ischemic stroke	Number and percentage of participants with an adjudicated ischemic stroke after LAAC.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 10: Cumulative incidence of transient ischemic attack	Number and percentage of participants with an adjudicated transient ischemic attack after LAAC.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 11: Cumulative incidence of systemic embolism	Number and percentage of participants with an adjudicated systemic embolic event after LAAC.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 12: Cumulative incidence of major bleeding	Number and percentage of participants with major bleeding defined as Bleeding Academic Research Consortium type 3 or higher.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 13: Cumulative incidence of clinically relevant nonmajor bleeding	Number and percentage of participants with clinically relevant nonmajor bleeding after LAAC.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 14: All-cause mortality	Number and percentage of participants who die from any cause after LAAC.From LAAC through 12 months; assessed at 3, 6, and 12 months	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 15: Cardiovascular mortality	Number and percentage of participants who die from a cardiovascular cause after LAAC, as adjudicated by the independent clinical event committee.	From LAAC through 12 months; assessed at 3, 6, and 12 months
Secondary outcome 16: Proportion of participants with modification of antithrombotic therapy	Number and percentage of participants whose antithrombotic regimen, intensity, or planned duration is modified on the basis of follow-up imaging findings or clinical events. The reason for each modification will be recorded.	From discharge through 12 months after LAAC; assessed at 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Xiaochun Zhang, Fudan University

Publications and helpful links

Helpful 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 record dates

Study Major Dates

• Study Start (Actual): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: September 6, 2026
• First Submitted That Met QC Criteria: September 6, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 6, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KY2026155-1; B2026-563 (Other Identifier: Medical Ethics Committee of Zhongshan Hospital, Fudan University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified individual participant data will not be shared because the currently approved informed consent permits coded study data to be used only within the scope of the present study and does not authorize use outside this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No