ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)

NCT01628068 | Unknown Phase 3 DMC

• 2 other identifiers: ELIGIBLEEstudio ELIGIBLE
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Adverse Reaction to Drugs Affecting the Gastrointestinal System

Keywords

Left atrial appendage occlusion; gastrointestinal bleeding

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year

Study Arms (2)

Left atrial appendage occlusion

ACTIVE COMPARATOR

Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months

Device: Left atrial appendage occlusion

Oral anticoagulation

NO INTERVENTION

Oral anticoagulation

Interventions

Left atrial appendage occlusion DEVICE

Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months

Left atrial appendage occlusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (6)

Hospital Infanta Cristina

Badajoz, Badajoz, 06006, Spain

RECRUITING

Fundació Clínic per a la Recerca Biomèdica

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital de La Paz

Madrid, Madrid, Spain

RECRUITING

Hospital Puerta de Hierro

Madrid, Mdrid, Spain

RECRUITING

Hospital Virgen de la Victoria

Málaga, Málaga, Spain

RECRUITING

Hospital Virgen de la Macarena

Seville, Sevilla, Spain

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Central Study Contacts

Victoria Martín Yuste, MD, PhD

CONTACT

+34-93-227-55-19; vmartiny@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: June 26, 2012

Record last verified: 2012-06

Locations

ES (6)