We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 Victoria Martin Yuste, Hospital Clinic of Barcelona.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01628068
First Posted: June 26, 2012
Last Update Posted: June 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Victoria Martin Yuste, Hospital Clinic of Barcelona
June 22, 2012
June 26, 2012
June 26, 2012
February 2012
July 2013   (Final data collection date for primary outcome measure)
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)
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adverse Reaction to Drugs Affecting the Gastrointestinal System
Device: Left atrial appendage occlusion
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
  • Active Comparator: Left atrial appendage occlusion
    Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
    Intervention: Device: Left atrial appendage occlusion
  • No Intervention: Oral anticoagulation
    Oral anticoagulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
July 2014
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01628068
ELIGIBLE
Estudio ELIGIBLE ( Other Identifier: Fundació Clínic )
Yes
Not Provided
Not Provided
Victoria Martin Yuste, Hospital Clinic of Barcelona
Hospital Clinic of Barcelona
Not Provided
Not Provided
Hospital Clinic of Barcelona
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP