Adverse Reaction to Drugs Affecting the Gastrointestinal System Clinical Trial
— ELIGIBLEOfficial 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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Infanta Cristina | Badajoz | |
| Spain | Fundació Clínic per a la Recerca Biomèdica | Barcelona | |
| Spain | Hospital de La Paz | Madrid | |
| Spain | Hospital Puerta de Hierro | Madrid | Mdrid |
| Spain | Hospital Virgen de la Victoria | Málaga | |
| Spain | Hospital Virgen de la Macarena | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Clinic of Barcelona |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. Mortality from any cause Severe bleeding defined according to VARC criteria Ischemic stroke or hemorrhagic stroke at 12 months. 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) |
1 year | Yes |