Nonvalvular Atrial FibrillationPEARL-LAACNCT07815119
TEE-Guided Versus CCTA-Guided Preprocedural Imaging for Left Atrial Appendage Closure
A study testing Transesophageal Echocardiography-Guided Preprocedural Assessment and Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment in people with Nonvalvular Atrial Fibrillation, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonvalvular Atrial Fibrillation
- What is being tested?
- Transesophageal Echocardiography-Guided Preprocedural Assessment and Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhognshan Hospital ,Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaochun Zhang, MD, +86-21-64041990 ext. 612846, zhang.xiaochun1@zs-hospital.sh.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Nonvalvular Atrial Fibrillation
- Being tested
- Transesophageal Echocardiography-Guided Preprocedural Assessment, Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal Echocardiography-Guided Preprocedural AssessmentDiagnostic 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.
Cardiac Computed Tomography Angiography-Guided Preprocedural AssessmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Cardiac Computed Tomography Angiography-Guided Preprocedural Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From discharge through 12 months after LAAC; assessed at 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonvalvular Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 to a TEE-guided or CCTA-guided preprocedural imaging assessment strategy before LAAC.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaochun Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815119
- Sponsor's protocol ID
- KY2026155-1
- Other IDs
- B2026-563
- Acronym
- PEARL-LAAC
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.