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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Victoria Martin Yuste, Hospital Clinic of Barcelona Identifier:
First received: June 22, 2012
Last updated: June 25, 2012
Last verified: June 2012

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.

Condition Intervention Phase
Adverse Reaction to Drugs Affecting the Gastrointestinal System
Device: Left atrial appendage occlusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding

Resource links provided by NLM:

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Combined overall mortality, major bleeding, stroke or procedure-related complications [ Time Frame: 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)

Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Left atrial appendage occlusion
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
Device: Left atrial appendage occlusion
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
No Intervention: Oral anticoagulation
Oral anticoagulation


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01628068

Contact: Victoria Martín Yuste, MD, PhD +34-93-227-55-19

Hospital Puerta de Hierro Recruiting
Madrid, Mdrid, Spain
Contact: Javier Goicolea, MD         
Sub-Investigator: Javier Goicolea, MD         
Sub-Investigator: José Antonio Fernández Díaz, MD         
Hospital Infanta Cristina Recruiting
Badajoz, Spain, 06006
Contact: José Ramón López Mínguez, MD, PhD    +34-924218100    lópez-mí   
Sub-Investigator: José Ramón López Mínguez, MD, PhD         
Fundació Clínic per a la Recerca Biomèdica Recruiting
Barcelona, Spain, 08036
Contact: Victoria Martín Yuste, MD, PhD    +34-932275400   
Principal Investigator: Victoria Martín Yuste, MD, PhD         
Sub-Investigator: Manel Sabaté Tenas, MD, PhD         
Hospital de La Paz Recruiting
Madrid, Spain
Contact: Raúl Moreno, MD, PhD         
Sub-Investigator: Raúl Moreno, MD,PhD         
Hospital Virgen de la Victoria Recruiting
Málaga, Spain
Contact: José María Hernández García, MD         
Sub-Investigator: José María Hernández García, MD         
Hospital Virgen de la Macarena Recruiting
Sevilla, Spain
Contact: Rafael Ruiz Salmerón, MD         
Sub-Investigator: Rafael Ruiz Salmerón, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
  More Information

Responsible Party: Victoria Martin Yuste, MD, PhD, Hospital Clinic of Barcelona Identifier: NCT01628068     History of Changes
Other Study ID Numbers: ELIGIBLE
Estudio ELIGIBLE ( Other Identifier: Fundació Clínic )
Study First Received: June 22, 2012
Last Updated: June 25, 2012

Keywords provided by Hospital Clinic of Barcelona:
Left atrial appendage occlusion
gastrointestinal bleeding

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Drug-Related Side Effects and Adverse Reactions
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Chemically-Induced Disorders processed this record on May 22, 2017