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

Hospital Clinic of Barcelona120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Adverse Reaction to Drugs Affecting the Gastrointestinal System

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Hospital Infanta Cristina

Badajoz, Badajoz, Spain

RECRUITING

Fundació Clínic per a la Recerca Biomèdica

Barcelona, Barcelona, Spain

RECRUITING

Hospital de La Paz

Madrid, Madrid, Spain

RECRUITING

Hospital Puerta de Hierro

Madrid, Mdrid, Spain

RECRUITING

Hospital Virgen de la Victoria

Málaga, Málaga, Spain

RECRUITING

Hospital Virgen de la Macarena

Seville, Sevilla, Spain

RECRUITING

Outcomes

Primary Outcomes

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. 1. Mortality from any cause 2. Severe bleeding defined according to VARC criteria 3. Ischemic stroke or hemorrhagic stroke at 12 months. 4. 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)

Time frame: 1 year

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Central Contacts