French Database of Left Atrial Appendage Closure

Study Overview
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Brief Summary
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Patients with atrial fibrillation are exposed to a high risk of thrombus in the left atrium that can induce cerebral vascular events or systemic embolisms. This justifies the prescription of anticoagulant therapies in patients with high risk of thromboembolic event. Percutaneous left atrial appendage closure is a new interventional strategy for patients with high risk of cardiovascular events and a counter-indication for long term treatment with anticoagulant agents. However, only few data are available on effectiveness and prognosis of patients treated by this new interventional strategy. This national database record per-procedure and follow-up data of patients treated by left atrial appendage closure. This database is strictly observational. Percutaneous left atrial appendage closure is performed only for the purpose of patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.

Official Title
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French Database of Left Atrial Appendage Closure

Conditions
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Atrial Fibrillation and Other Dysrhythmias | Patient

Intervention / Treatment
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* Other: Percutaneous Left Atrial Appendage Closure in routine care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred to a french interventional cardiology department for percutaneous left atrial appendage closure in routine care Signature of an inform consent form for inclusion of data recorded during care in the database Exclusion Criteria: none

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Left Atrial Appendage Closure<br>Patients with atrial fibrillation and counter-indication to anticoagulant therapy referred for percutaneous Left Atrial Appendage Closure in routine care | Other: Percutaneous Left Atrial Appendage Closure in routine care<br>* The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the rate of thromboembolic events related to atrial fibrillation in patients treated by left atrial appendage closure in daily practice in France |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of patient management in daily practice after left atrial appendage closure (number of echocardiography procedures) |  | 1 year | 
| Death rate from cardiovascular disease after left atrial appendage closure |  | 1 year | 
| Unexplained Death rate after left atrial appendage closure |  | 1 year | 
| Adverse events related to the procedure |  | 1 year | 
| Cost of the procedure of left atrial appendage closure |  | Costs will be assessed for the duration of hospital stay, an expected average of 3 days | 
| Cost of patient follow-up after left atrial appendage closure |  | 1 year | 
| Assessment of patient medical treatment in daily practice after left atrial appendage closure (percentage of patients with antiplatelet drugs) |  | 1 year |