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

Tracking Information

First Received Date ^ICMJE

June 22, 2012

Last Updated Date

June 25, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Mortality from any cause
Severe bleeding defined according to VARC criteria
Ischemic stroke or hemorrhagic stroke at 12 months.
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)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01628068 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Adverse Reaction to Drugs Affecting the Gastrointestinal System

Intervention ^ICMJE

Device: Left atrial appendage occlusion

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Victoria Martín Yuste, MD, PhD

+34-93-227-55-19

vmartiny@clinic.ub.es

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01628068

Other Study ID Numbers ^ICMJE

ELIGIBLE, Estudio ELIGIBLE

Has Data Monitoring Committee

Yes

Responsible Party

Victoria Martin Yuste, Hospital Clinic of Barcelona

Study Sponsor ^ICMJE

Hospital Clinic of Barcelona

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Hospital Clinic of Barcelona

Verification Date

June 2012

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

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