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Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure. (EPI-ENDO)

Primary Purpose

Heart Failure, Cardiomyopathy, Dilated, Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Resynchronization using a transeptal approach
Resynchronization using a coronary sinus approach
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, cardiac resynchronization therapy, Hemodynamics, Randomized Controlled Trials, Open Study

Eligibility Criteria

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

Inclusion Criteria:

  • Adult (aged 18 or above)
  • Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
  • Left ventricular ejection fraction <35%
  • NYHA Class III or IV with optimal medical treatment
  • QRS duration > 120 ms
  • Sinus rhythm
  • Patient must have signed informed consent
  • Patient must be registered in the national health care system

Exclusion Criteria:

  • Aged under 18
  • Patient with a mitral or aortic prosthesis
  • Patient with contraindication to anti-coagulants
  • Pregnant women
  • Participation in another study
  • Patient with contraindication for left ventricle catheterization by retrograde aortic approach , as a severe aortic stenosis requiring surgery, or an ascending aorta aneurism

Sites / Locations

  • Cardiologic Hospital Haut l'évêque

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Epicardial

Endocardial

Arm Description

Outcomes

Primary Outcome Measures

the acute hemodynamic response judged by dP/dt max
The primary outcome will be the acute hemodynamic response of the randomized pacing modality (endocardial vs epicardial Left Ventricle pacing) as judged by the highest gain in dP/dt max

Secondary Outcome Measures

Implant success rate
number of left ventricular pacing sites assessed
Pacing Procedure duration
Per and post implantation complications rate
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism
sensing performances of left ventricle pacing leads
pacing threshold performances of left ventricle pacing leads
impedances performances of left ventricle pacing leads
Complications rate at 6 month Follow up
Clinical benefit at 6 month Follow up: Gain in NYHA
Clinical benefit at 6 month Follow up: 6 minutes walk test
Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes
Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation
Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism
Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism
sensing performances of Left Ventricle pacing leads at 6 month Follow up
pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up
impedances performances of Left Ventricle pacing leads at 6 month Follow up

Full Information

First Posted
December 8, 2010
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01260402
Brief Title
Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
Acronym
EPI-ENDO
Official Title
Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
July 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV). It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
Keywords
heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, cardiac resynchronization therapy, Hemodynamics, Randomized Controlled Trials, Open Study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epicardial
Arm Type
Active Comparator
Arm Title
Endocardial
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Resynchronization using a transeptal approach
Intervention Description
Cardiac resynchronization with one in the right ventricle and one in the left ventricle via a transeptal puncture. Devices used for procedure : Medtronic C304 or 6227DEF, Nykanen RF Wire, RADI PressureWire
Intervention Type
Device
Intervention Name(s)
Resynchronization using a coronary sinus approach
Intervention Description
Cardiac resynchronization with one in the right ventricle and one in the left ventricle via the coronary sinus. Devices used for procedure : RADI PressureWire, routine catheters chosen by operator
Primary Outcome Measure Information:
Title
the acute hemodynamic response judged by dP/dt max
Description
The primary outcome will be the acute hemodynamic response of the randomized pacing modality (endocardial vs epicardial Left Ventricle pacing) as judged by the highest gain in dP/dt max
Time Frame
Visit 3 : implantation day, during pacing procedure
Secondary Outcome Measure Information:
Title
Implant success rate
Time Frame
Visit 3 : implantation day, end of pacing procedure
Title
number of left ventricular pacing sites assessed
Time Frame
Visit 3 : implantation day, end of pacing procedure
Title
Pacing Procedure duration
Time Frame
Visit 3 : implantation day, end of pacing procedure
Title
Per and post implantation complications rate
Time Frame
Visit 4 : within 7 days after pacing procedure
Title
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction
Time Frame
within 7 days after pacing procedure
Title
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation
Time Frame
within 7 days after pacing procedure
Title
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism
Time Frame
within 7 days after pacing procedure
Title
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism
Time Frame
within 7 days after pacing procedure
Title
sensing performances of left ventricle pacing leads
Time Frame
within 7 days after pacing procedure
Title
pacing threshold performances of left ventricle pacing leads
Time Frame
within 7 days after pacing procedure
Title
impedances performances of left ventricle pacing leads
Time Frame
within 7 days after pacing procedure
Title
Complications rate at 6 month Follow up
Time Frame
Visit 6 : 6-months after pacing procedure
Title
Clinical benefit at 6 month Follow up: Gain in NYHA
Time Frame
6-months after pacing procedure
Title
Clinical benefit at 6 month Follow up: 6 minutes walk test
Time Frame
6-months after pacing procedure
Title
Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation
Time Frame
6-months after pacing procedure
Title
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction
Time Frame
6-months after pacing procedure
Title
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes
Time Frame
6-months after pacing procedure
Title
Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation
Time Frame
6-months after pacing procedure
Title
Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism
Time Frame
6-months after pacing procedure
Title
Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism
Time Frame
6-months after pacing procedure
Title
sensing performances of Left Ventricle pacing leads at 6 month Follow up
Time Frame
6-months after pacing procedure
Title
pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up
Time Frame
6-months after pacing procedure
Title
impedances performances of Left Ventricle pacing leads at 6 month Follow up
Time Frame
6-months after pacing procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (aged 18 or above) Cardiac insufficiency of whatever cause (ischemic or non-ischemic) Left ventricular ejection fraction <35% NYHA Class III or IV with optimal medical treatment QRS duration > 120 ms Sinus rhythm Patient must have signed informed consent Patient must be registered in the national health care system Exclusion Criteria: Aged under 18 Patient with a mitral or aortic prosthesis Patient with contraindication to anti-coagulants Pregnant women Participation in another study Patient with contraindication for left ventricle catheterization by retrograde aortic approach , as a severe aortic stenosis requiring surgery, or an ascending aorta aneurism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre JAIS, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiologic Hospital Haut l'évêque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

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