Nonvalvular Atrial Fibrillation
Conditions
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.
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.
Interventions
DIAGNOSTIC_TESTTransesophageal 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.
DIAGNOSTIC_TESTCardiac 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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Participants are randomized 1:1 to a TEE-guided or CCTA-guided preprocedural imaging assessment strategy before LAAC.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome: Composite incidence of periprocedural serious safety events | From the start of the LAAC procedure through 30 days after the procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| Secondary outcome 2: Proportion of procedures requiring replacement of the initially selected occluder | During the LAAC procedure | 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. |
| Secondary outcome 3: Proportion of participants requiring crossover to the nonassigned preprocedural imaging strategy | From randomization through completion of preprocedural planning | 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. |
| Secondary outcome 4: Technical success of left atrial appendage closure | At completion of the LAAC procedure | 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. |
| 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 | 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. |
| Secondary outcome 6: Proportion of participants with device-related thrombus | 3 months after LAAC (allowed window: plus or minus 2 weeks) | Number and percentage of participants with device-related thrombus detected by TEE or CCTA and confirmed by the blinded imaging core laboratory. |
| Secondary outcome 7: Proportion of participants with residual left atrial appendage patency | 3 months after LAAC (allowed window: plus or minus 2 weeks) | Number and percentage of participants with residual left atrial appendage patency detected by TEE or CCTA and confirmed by the blinded imaging core laboratory. |
| Secondary outcome 8: Paired agreement and disagreement between TEE and CCTA for key imaging abnormalities | 3 months after LAAC (allowed window: plus or minus 2 weeks) | 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. |
| Secondary outcome 9: Cumulative incidence of ischemic stroke | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants with an adjudicated ischemic stroke after LAAC. |
| Secondary outcome 10: Cumulative incidence of transient ischemic attack | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants with an adjudicated transient ischemic attack after LAAC. |
| Secondary outcome 11: Cumulative incidence of systemic embolism | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants with an adjudicated systemic embolic event after LAAC. |
| Secondary outcome 12: Cumulative incidence of major bleeding | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants with major bleeding defined as Bleeding Academic Research Consortium type 3 or higher. |
| Secondary outcome 13: Cumulative incidence of clinically relevant nonmajor bleeding | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants with clinically relevant nonmajor bleeding after LAAC. |
| Secondary outcome 14: All-cause mortality | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants who die from any cause after LAAC.From LAAC through 12 months; assessed at 3, 6, and 12 months |
| Secondary outcome 15: Cardiovascular mortality | From LAAC through 12 months; assessed at 3, 6, and 12 months | Number and percentage of participants who die from a cardiovascular cause after LAAC, as adjudicated by the independent clinical event committee. |
| Secondary outcome 16: Proportion of participants with modification of antithrombotic therapy | From discharge through 12 months after LAAC; assessed at 3, 6, and 12 months | 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. |
Countries
China
Contacts
CONTACTHao Jiang, MD
CONTACTXiaochun Zhang, MD
PRINCIPAL_INVESTIGATORXiaochun Zhang
Fudan University
Outcome results
None listed