The Role of Multimodality Imaging in Left Atrial Appendage Closure

Study Overview
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Brief Summary
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The aim of the present prospective, randomized single-centre study is to examine the success rate, safety, overall preoperative and operative burden and long-time outcome of percutaneous left atrial appendage closure procedures after unimodal and multimodal preprocedural imaging. According to the investigators' primary hypothesis, simple, unimodal preprocedural imaging does not increase procedural burden of LAAC (total radiation dose, procedure time, fluoroscopy time, contrast amount). The investigators assume, that the success rate and safety of LAAC procedures is not reduced using unimodal preoperative imaging. Regarding to postoperative imaging, the investigators aim to compare the sensitivity of different imaging techniques in detecting postoperative complications. We assume, that multimodal imaging technique increases the accuracy and sensitivity of the detection of postoperative complications (PDL, device thrombi).

Detailed Description
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Left atrial appendage closure (LAAC) is an increasingly used non-pharmacologic strategy to prevent stroke in patients with atrial fibrillation who have absolute or relative contraindications to long-term oral anticoagulant therapy, mainly due to previous major bleeding or high bleeding risk. As the majority of candidates are elderly patients with multiple morbidities, the reduction of procedural burden is of huge significance. The aim of the present prospective, randomized, single-centre study is to examine the non-inferiority of unimodal (MDCT) vs. multimodal (MDCT+TOE) preprocedural imaging in percutaneous left atrial appendage closure. The investigators are going to assess the success rate, safety and complications of LAAC procedures, and determine the procedural burden (total radiation dose, procedure time, fluoroscopy time, contrast amount) of the interventions after preprocedural unimodal and multimodal appendage characterization and device sizing. Multimodal procedural guidance (2D/3D TOE, fluoroscopy-angiography) and multimodal postprocedural imaging (2D/3D TOE, MDCT) is going to be used to identify complications (peri-device leak, thrombus). The investigators are planning to compare the accuracy and additive value of different postoperative imaging techniques. .

Official Title
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The Role of Multimodality Imaging in Left Atrial Appendage Closure

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Diagnostic Test: Multimodal imaging
* Diagnostic Test: Standard imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, who have clinical indication to LAAC and are undergoing percutaneous LAAC procedure in Gottsegen National Cardiovascular Center from 10.03.2021 to 31.12.2025 Age above 18 years Informed consent Legal capacity Exclusion Criteria: Age under 18 years Pregnancy Incapacitation Absence of consent Esophageal stenosis or diverticulum Active esophageal bleeding CT-contrast agent allergy Severe chronic kidney disease (GFR<15 ml/min/1,73 m2) Appendage thrombus (mobile/with significant embolic risk) Life expectancy shorter than 12 months Active infection Significant mitral valve stenosis Mechanical heart valve Open heart surgery is indicated

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized one-centre trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimodal imaging<br>Preoperative 2D/3D TOE AND MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus) | Diagnostic Test: Multimodal imaging<br>* Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT<br>|
| Experimental: Standard imaging<br>Preoperative MDCT for appendage characterisation and sizing Operative 2D/3D TOE and fluoroscopy/angiography for guiding and checking the procedural events and success Postoperative 2D/3D TOE and MDCT to assess the complications (peri-device leak, thrombus) | Diagnostic Test: Standard imaging<br>* Preoperative MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective radiation dose | Total radiation dose of the patient resorbed during LAAC imaging and intervention (mSv) | Periprocedural (1 month) interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time | during LAAC procedure (min) | during the procedure | 
| Procedure time | of LAAC procedure (min) | during the procedure | 
| Contrast media amount | used during LAAC procedure (ml) | during the procedure | 
| Rate of successful implantations | left atrial appendage occluder successfully deployed and released | during the procedure | 
| Rate of patients with adequate seal of closure device | Adequate seal defined as no leak or residual leak< 5 mm established by postoperative TOE | 6 weeks post-procedure | 
| Rate of procedural complications | Thromboembolic events, myocardial infarction, bleeding events, vascular complications, pericardial effusion, tamponade, infections, allergic reactions, renal insufficiency, device/air embolism, mortality | within 30 days post-procedure | 
| Rate of clinical events | Composite endpoint of thromboembolic events (ischemic stroke, TIA, systemic embolism) | 2 years post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, ischemic stroke, left atrial appendage closure, bleeding