ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)

Study Overview
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Brief Summary
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Patients with atrial fibrillation requiring anticoagulation treatment are at high risk of gastrointestinal bleeding. The investigators propose the percutaneous stop the oral anticoagulation and closure of the left atrial appendage with the Amplatzer ® system in patients receiving anticoagulant therapy for atrial fibrillation without associated valvular heart disease, to reduce significantly the risk of stroke while minimizing the risk of bleeding in a group of patients with high risk for both events. ELIGIBLE trial(Left atrial appendage Efficacy of GastroIntestinal Bleeding after closure) is a prospective, multicentric and randomized (2 to 1) trial, comparing percutaneous closure of atrial appendage left versus standard treatment with oral anticoagulants in patients with history of gastrointestinal bleeding and high embolic risk.

Official Title
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Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding

Conditions
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Adverse Reaction to Drugs Affecting the Gastrointestinal System

Intervention / Treatment
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* Device: Left atrial appendage occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease > 18 years Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants CHA2-DS2-VASC score ≥ 3 prior digestive bleeding without any treatable cause Informed consent. Exclusion Criteria: POF contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel) Intracardiac thrombus significant carotid disease Cardioversion scheduled within 30 days following the implantation AF not controlled by FVM> 100 bpm AF secondary to surgery or ablation thrombosis in patients <40 years chronic renal insufficiency with Cr clearance <30 ml 2 left appendage sizeappendage with inlet <12.6 mm or > 28.5 (ETE) depth of the appendage <10mm in the TEE

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Left atrial appendage occlusion<br>Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months | Device: Left atrial appendage occlusion<br>* Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months<br>|
| No Intervention: Oral anticoagulation<br>Oral anticoagulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined overall mortality, major bleeding, stroke or procedure-related complications | The primary end point will be at one year the combined overall mortality, major bleeding, stroke or procedure-related complications. Mortality from any cause Severe bleeding defined according to VARC criteria Ischemic stroke or hemorrhagic stroke at 12 months. Complications related to the procedure: include: device embolization severe pericardial effusion with hemodynamic compromise that requires drainage Device thrombosis cardiac perforation major local complications (according to definitions of VARC) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left atrial appendage occlusion, gastrointestinal bleeding