LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure

Study Overview
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Brief Summary
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The study aims at comparing, in a large cohort of consecutive clinically indicated left atrial appendage closure, clinical and imaging outcomes between different subpopulations.

Detailed Description
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Percutaneous left atrial appendage closure (LAAC) has established itself in clinical practice as a safe and efficient therapeutic option for atrial fibrillation patients with a relative/absolute contraindication to oral anticoagulation. The purpose of this observational study is to prospectively collect procedural and follow-up data of all patients submitted to a clinically indicate LAAC in order to assess the impact of patient characteristics, procedural technique (imaging used to guide/plan procedure, device implanted, post-procedural drug regimens, etc.) on procedural safety and efficacy. The endpoints will be assessed by means of clinical follow-up at 1-3-5 years after LAAC and imaging exams (TEE at1-3 months, CCTA at 1-13months).

Official Title
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LAAC-registry: Clinical Outcome After Echocardiography-guided LAA-closure

Conditions
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Atrial Fibrillation, Cardiovascular Diseases, Thromboembolism

Intervention / Treatment
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* Other: Use of echocardiography guidance for LAAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 Written informed consent to participate in the study Patients with paroxysmal, persistent, or permanent non-valvular AF and CHA2DS2-VASc Score of ≥2 that are planned for an elective LAA-closure Anatomic characteristics allow placement of a CE marked device, dedicated for LAAC Exclusion Criteria: None. Considering the nature of the project, which is to prospectively collect information on all patients treated with LAAC in our center, we will only exclude patients unwilling to sign the informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Use of echocardiography guidance for LAAC|Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Composite of Death, cerebrovascular events, cardiac tamponade, need for urgent surgery, need for cardiopulmonary resuscitation, device embolization, non vascular access-related major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) or acute kidney injury. | 7 days | 
| Primary Efficacy Endpoint - Incidence of cardiovascular death, ischemic stroke and systemic embolism | Protection from cardiovascular death, ischemic stroke and systemic embolism | 1 to 5 Years | 
| Secondary Efficacy Endpoint - Incidence of technical success | Technical success defined as adequate LAA ostium closure (without residual PDL>5mm or patent lobes) in absence of device complications (according to the Munich Consensus Document) | 7 days to 13 months | 
| Feasibility Endpoint - Total procedure time (min) | Total procedure time (min) | During the LAAC Procedure (≃ 60 minutes ) | 
| Feasibility Endpoint - dose of contrast medium (ml) | dose of contrast medium (ml) | During the LAAC Procedure (≃ 60 minutes ) | 
| Feasibility Endpoint - dose of x-ray (cGy.cm2) | dose of x-ray (cGy.cm2) | During the LAAC Procedure (≃ 60 minutes ) | 
| Feasibility Endpoint - number of device implantation attempt during the procedure (number) | number of device implantation attempt during the procedure (number) | During the LAAC Procedure (≃ 60 minutes ) | 
| Feasibility Endpoint - number of device change during the procedure (number) | number of device change during the procedure (number) | During the LAAC Procedure (≃ 60 minutes ) | 
| Net Clinical Benefit Endpoint | Composite of death, stroke, systemic embolism, pulmonary embolism, myocardial infarction, and major or life-threatening bleeding (according to the Bleeding academic research Criteria (BARC) type 3a, 3b, 3c, or 5) not procedure-related. | 1 to 5 years | 
| LAA patency | LAA patency and its subtypes as evaluated by TEE and/or CCTA | 45 days to 13 months | 
| Device related thrombus | Device related thrombus detected by TEE and /or CCTA on the atrial surface of device | 45 days to 13months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of atrial surface of device covered | % (device sealing surrogate) | 45 days - 3 months - 13months | 
| Maximal Hypoattentuated Thickening on atrial surface of device | mm (device sealing surrogate) | 45 days - 3 months - 13months | 
| Percentage of device length coverage | % (device sealing surrogate) | 45 days - 3 months - 13months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left atrial appendage closure, Amulet, Watchman, Watchman flx, Acp, Cardiac computed tomography angiography, Transesophageal echocardiography, Peridevice leak, Thromboembolic events, Atrial fibrillation