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| ID | Type | Description | Link |
|---|---|---|---|
| Estudio ELIGIBLE | Other Identifier | Fundació Clínic |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left atrial appendage occlusion | Active Comparator | Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months |
|
| Oral anticoagulation | No Intervention | Oral anticoagulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Left atrial appendage occlusion | Device | Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Martín Yuste, MD, PhD | Contact | +34-93-227-55-19 | vmartiny@clinic.ub.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infanta Cristina | Recruiting | Badajoz | Badajoz | 06006 | Spain |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000097546 | Left Atrial Appendage Closure |
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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| Fundació Clínic per a la Recerca Biomèdica | Recruiting | Barcelona | Barcelona | 08036 | Spain |
|
| Hospital de La Paz | Recruiting | Madrid | Madrid | Spain |
|
| Hospital Puerta de Hierro | Recruiting | Madrid | Mdrid | Spain |
|
| Hospital Virgen de la Victoria | Recruiting | Málaga | Málaga | Spain |
|
| Hospital Virgen de la Macarena | Recruiting | Seville | Sevilla | Spain |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |