A Phase 3 interventional study of Left atrial appendage occlusion in Adverse Reaction to Drugs Affecting the Gastrointestinal System, sponsored by Hospital Clinic of Barcelona. Status unknown at 6 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-26.
Sponsored by Hospital Clinic of Barcelona · Phase 3, Interventional, and Treatment
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 120 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
Device: Left atrial appendage occlusion
Oral anticoagulation
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
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
This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Hospital Clinic of Barcelona