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

Primary Purpose

Adverse Reaction to Drugs Affecting the Gastrointestinal System

Status
Unknown status
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Left atrial appendage occlusion
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adverse Reaction to Drugs Affecting the Gastrointestinal System focused on measuring Left atrial appendage occlusion, gastrointestinal bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Puerta de HierroRecruiting
  • Hospital Infanta CristinaRecruiting
  • Fundació Clínic per a la Recerca BiomèdicaRecruiting
  • Hospital de La PazRecruiting
  • Hospital Virgen de la VictoriaRecruiting
  • Hospital Virgen de la MacarenaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Left atrial appendage occlusion

Oral anticoagulation

Arm Description

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

Oral anticoagulation

Outcomes

Primary Outcome Measures

Combined overall mortality, major bleeding, stroke or procedure-related complications
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)

Secondary Outcome Measures

Full Information

First Posted
June 22, 2012
Last Updated
June 25, 2012
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT01628068
Brief Title
ELIGIBLE (Efficacy of Left atrIal Appendage Closure After GastroIntestinal BLEeding)
Acronym
ELIGIBLE
Official Title
Efficacy of Left Atrial Appendage Closure After Gastrointestinal Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Reaction to Drugs Affecting the Gastrointestinal System
Keywords
Left atrial appendage occlusion, gastrointestinal bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left atrial appendage occlusion
Arm Type
Active Comparator
Arm Description
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
Arm Title
Oral anticoagulation
Arm Type
No Intervention
Arm Description
Oral anticoagulation
Intervention Type
Device
Intervention Name(s)
Left atrial appendage occlusion
Intervention Description
Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
Primary Outcome Measure Information:
Title
Combined overall mortality, major bleeding, stroke or procedure-related complications
Description
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)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Martín Yuste, MD, PhD
Phone
+34-93-227-55-19
Email
vmartiny@clinic.ub.es
Facility Information:
Facility Name
Hospital Puerta de Hierro
City
Madrid
State/Province
Mdrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Goicolea, MD
First Name & Middle Initial & Last Name & Degree
Javier Goicolea, MD
First Name & Middle Initial & Last Name & Degree
José Antonio Fernández Díaz, MD
Facility Name
Hospital Infanta Cristina
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ramón López Mínguez, MD, PhD
Phone
+34-924218100
Email
lópez-mínguez@hotmail.com
First Name & Middle Initial & Last Name & Degree
José Ramón López Mínguez, MD, PhD
Facility Name
Fundació Clínic per a la Recerca Biomèdica
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Martín Yuste, MD, PhD
Phone
+34-932275400
Email
vmartiny@clinic.ub.es
First Name & Middle Initial & Last Name & Degree
Victoria Martín Yuste, MD, PhD
First Name & Middle Initial & Last Name & Degree
Manel Sabaté Tenas, MD, PhD
Facility Name
Hospital de La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raúl Moreno, MD, PhD
First Name & Middle Initial & Last Name & Degree
Raúl Moreno, MD,PhD
Facility Name
Hospital Virgen de la Victoria
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José María Hernández García, MD
First Name & Middle Initial & Last Name & Degree
José María Hernández García, MD
Facility Name
Hospital Virgen de la Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Ruiz Salmerón, MD
First Name & Middle Initial & Last Name & Degree
Rafael Ruiz Salmerón, MD

12. IPD Sharing Statement

Learn more about this trial

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

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