Adverse Reaction to Drugs Affecting the Gastrointestinal System Clinical Trial
Official title:
Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment