NCT01628068

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

Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adverse Reaction to Drugs Affecting the Gastrointestinal System

Interventions

Type	Name	Description
DEVICE	Left atrial appendage occlusion	Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2012-06-26
• Last updated: 2012-06-26

Locations

6 sites across 1 country: Spain