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

Hospital Clinic of Barcelona

Status and phase: Unknown; Phase 3

Conditions: Adverse Reaction to Drugs Affecting the Gastrointestinal System

Treatments: Device: Left atrial appendage occlusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01628068

ELIGIBLE

Estudio ELIGIBLE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Left atrial appendage occlusion

Active Comparator group

Description:

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

Treatment:

Device: Left atrial appendage occlusion

Oral anticoagulation

No Intervention group

Description:

Oral anticoagulation