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

University Hospital, Bordeaux1 site in 1 country6 target enrollmentMarch 3, 2011

ConditionsHeart Failure Cardiomyopathy, Dilated Coronary Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: University Hospital, Bordeaux
Enrollment: 6
Locations: 1
Primary Endpoint: the acute hemodynamic response judged by dP/dt max
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 3, 2011

End Date

July 30, 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Bordeaux

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

the acute hemodynamic response judged by dP/dt max

Time Frame: Visit 3 : implantation day, during pacing procedure

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 Outcomes

Pacing Procedure duration(Visit 3 : implantation day, end of pacing procedure)
Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation(6-months after pacing procedure)
Per and post implantation complications rate(Visit 4 : within 7 days after pacing procedure)
Clinical benefit at 6 month Follow up: 6 minutes walk test(6-months after pacing procedure)
pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up(6-months after pacing procedure)
number of left ventricular pacing sites assessed(Visit 3 : implantation day, end of 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)
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)
impedances performances of Left Ventricle pacing leads at 6 month Follow up(6-months after pacing procedure)
Implant success rate(Visit 3 : implantation day, end of 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 inter and intra-ventricular asynchronism(6-months after pacing procedure)
Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism(6-months after pacing procedure)
sensing performances of Left Ventricle pacing leads at 6 month Follow up(6-months after pacing procedure)