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

Phase 3

• Conditions: Adverse Reaction to Drugs Affecting the Gastrointestinal System
• Interventions: Device: Left atrial appendage occlusion

• Registration Number: NCT01628068
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Status Verified: 2012-06
• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-06-25
• Last Update Submitted: 2012-06-25
• Study First Posted: 2012-06-26
• Last Update Posted: 2012-06-26
• Primary Completion: 2013-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left atrial appendage occlusion	Left atrial appendage occlusion	Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months

Primary Outcome Measures

Name	Time	Method
Combined overall mortality, major bleeding, stroke or procedure-related complications	1 year	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)

Trial Locations

Locations (6)

Hospital de La Paz; 🇪🇸 Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Mdrid, Spain

Hospital Infanta Cristina; 🇪🇸 Badajoz, Spain

Hospital Virgen de la Victoria; 🇪🇸 Málaga, Spain

Fundació Clínic per a la Recerca Biomèdica; 🇪🇸 Barcelona, Spain

Hospital Virgen de la Macarena; 🇪🇸 Sevilla, Spain