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

This study is currently recruiting participants.
Verified June 2012 by Hospital Clinic of Barcelona
Sponsor:
Information provided by (Responsible Party):
Victoria Martin Yuste, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01628068
First received: June 22, 2012
Last updated: June 25, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628068

Contacts
Contact: Victoria Martín Yuste, MD, PhD +34-93-227-55-19 vmartiny@clinic.ub.es

Locations
Spain
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-mínguez@hotmail.com    
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     vmartiny@clinic.ub.es    
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

No publications provided

Responsible Party: Victoria Martin Yuste, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01628068     History of Changes
Other Study ID Numbers: ELIGIBLE, Estudio ELIGIBLE
Study First Received: June 22, 2012
Last Updated: June 25, 2012
Health Authority: Spain: Departament de Salut de la Generalitat de Catalunya

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

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Drug Toxicity
Gastrointestinal Diseases
 Digestive System Diseases
Pathologic Processes
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013