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.
1. Age 18 years or older. 2. Diagnosis of nonvalvular atrial fibrillation, including paroxysmal, persistent, or permanent atrial fibrillation.
1. Atrial fibrillation with moderate or severe mitral stenosis or a history of mechanical valve replacement.
Parallel
Transesophageal Echocardiography-Guided Preprocedural Assessment
Diagnostic testTEE 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 Assessment
Diagnostic testCCTA 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.
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.
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.
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.
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.
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.
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