Adverse Reaction to Drugs Affecting the Gastrointestinal System
Conditions
Keywords
Left atrial appendage occlusion, gastrointestinal bleeding
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.
Interventions
DEVICELeft atrial appendage occlusion
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Spain
Contacts
Primary ContactVictoria Martín Yuste, MD, PhD
Outcome results
None listed