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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Coronary Disease; Cardiomyopathy, Dilated
• Intervention / Treatment: Device: Resynchronization using a coronary sinus approach; Device: Resynchronization using a transeptal approach

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Cardiologic Hospital Haut l'évêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epicardial	Device: Resynchronization using a coronary sinus approach; 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
Experimental: Endocardial	Device: Resynchronization using a transeptal approach; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Visit 3 : implantation day, during pacing procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Implant success rate	Visit 3 : implantation day, end of pacing procedure
number of left ventricular pacing sites assessed	Visit 3 : implantation day, end of pacing procedure
Pacing Procedure duration	Visit 3 : implantation day, end of pacing procedure
Per and post implantation complications rate	Visit 4 : within 7 days after pacing procedure
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction	within 7 days after pacing procedure
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation	within 7 days after pacing procedure
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism	within 7 days after pacing procedure
Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism	within 7 days after pacing procedure
sensing performances of left ventricle pacing leads	within 7 days after pacing procedure
pacing threshold performances of left ventricle pacing leads	within 7 days after pacing procedure
impedances performances of left ventricle pacing leads	within 7 days after pacing procedure
Complications rate at 6 month Follow up	Visit 6 : 6-months after pacing procedure
Clinical benefit at 6 month Follow up: Gain in NYHA	6-months after pacing procedure
Clinical benefit at 6 month Follow up: 6 minutes walk test	6-months after pacing procedure
Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation	6-months after pacing procedure
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction	6-months after pacing procedure
Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes	6-months after pacing procedure
Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation	6-months after pacing procedure
Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism	6-months after pacing procedure
Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism	6-months after pacing procedure
sensing performances of Left Ventricle pacing leads at 6 month Follow up	6-months after pacing procedure
pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up	6-months after pacing procedure
impedances performances of Left Ventricle pacing leads at 6 month Follow up	6-months after pacing procedure

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Pierre JAIS, MD, University Hospital Bordeaux, France

Publications and helpful links

General Publications

• Kitamura T, Martin R, Frontera A, Jais P. Atrial tachycardia originating from deep septum following catheter ablation for persistent atrial fibrillation. Europace. 2018 Oct 1;20(10):1590. doi: 10.1093/europace/euy060. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimated): December 15, 2010

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: cardiac resynchronization therapy; Randomized Controlled Trials; heart failure; Hemodynamics; Coronary disease; Cardiac Pacing, Artificial; Cardiomyopathy, dilated; Open Study
• Additional Relevant MeSH Terms: Laminopathies; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Genetic Diseases, Inborn; Cardiomyopathies; Myocardial Ischemia; Cardiomegaly; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Failure; Cardiomyopathy, Dilated; Coronary Disease
• Other Study ID Numbers: CHUBX 2010/12; 2010-A00772-37 (Other Identifier: ANSM)