Clinical trial NCT01260402: Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
Official title: Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: the acute hemodynamic response judged by dP/dt max
timeFrame: Visit 3 : implantation day, during pacing procedure
Secondary outcomes:
measure: Implant success rate
timeFrame: Visit 3 : implantation day, end of pacing procedure
measure: number of left ventricular pacing sites assessed
timeFrame: Visit 3 : implantation day, end of pacing procedure
measure: Pacing Procedure duration
timeFrame: Visit 3 : implantation day, end of pacing procedure
measure: Per and post implantation complications rate
timeFrame: Visit 4 : within 7 days after pacing procedure
measure: Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction
timeFrame: within 7 days after pacing procedure
measure: Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation
timeFrame: within 7 days after pacing procedure
measure: Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism
timeFrame: within 7 days after pacing procedure
measure: Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism
timeFrame: within 7 days after pacing procedure
measure: sensing performances of left ventricle pacing leads
timeFrame: within 7 days after pacing procedure
measure: pacing threshold performances of left ventricle pacing leads
timeFrame: within 7 days after pacing procedure
measure: impedances performances of left ventricle pacing leads
timeFrame: within 7 days after pacing procedure
measure: Complications rate at 6 month Follow up
timeFrame: Visit 6 : 6-months after pacing procedure
measure: Clinical benefit at 6 month Follow up: Gain in NYHA
timeFrame: 6-months after pacing procedure
measure: Clinical benefit at 6 month Follow up: 6 minutes walk test
timeFrame: 6-months after pacing procedure
measure: Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation
timeFrame: 6-months after pacing procedure
measure: Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction
timeFrame: 6-months after pacing procedure
measure: Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes
timeFrame: 6-months after pacing procedure
measure: Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation
timeFrame: 6-months after pacing procedure
measure: Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism
timeFrame: 6-months after pacing procedure
measure: Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism
timeFrame: 6-months after pacing procedure
measure: sensing performances of Left Ventricle pacing leads at 6 month Follow up
timeFrame: 6-months after pacing procedure
measure: pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up
timeFrame: 6-months after pacing procedure
measure: impedances performances of Left Ventricle pacing leads at 6 month Follow up
timeFrame: 6-months after pacing procedure
Other outcomes:
Locations:
city: Pessac
country: France
facility: Cardiologic Hospital Haut l'évêque
Study officials:
affiliation: University Hospital Bordeaux, France
name: Pierre JAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: