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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
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

June 22, 2012
June 25, 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 ] [ 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)
Same as current
Complete list of historical versions of study NCT01628068 on ClinicalTrials.gov Archive Site
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
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
Both
18 Years and older
No
Contact: Victoria Martín Yuste, MD, PhD +34-93-227-55-19 vmartiny@clinic.ub.es
Spain
 
NCT01628068
ELIGIBLE, Estudio ELIGIBLE
Yes
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