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

University Hospital, Bordeaux6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure Cardiomyopathy, Dilated Coronary Disease

Interventions

Resynchronization using a transeptal approachDEVICE

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

Resynchronization using a coronary sinus approachDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cardiologic Hospital Haut l'évêque

Pessac, France

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Implant success rate

Time frame: Visit 3 : implantation day, end of pacing procedure

number of left ventricular pacing sites assessed

Time frame: Visit 3 : implantation day, end of pacing procedure

Pacing Procedure duration

Time frame: Visit 3 : implantation day, end of pacing procedure

Per and post implantation complications rate

Time frame: Visit 4 : within 7 days after pacing procedure

Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction

Time frame: within 7 days after pacing procedure

Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation

Time frame: within 7 days after pacing procedure

Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism

Time frame: within 7 days after pacing procedure

Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism

Time frame: within 7 days after pacing procedure

sensing performances of left ventricle pacing leads

Time frame: within 7 days after pacing procedure

pacing threshold performances of left ventricle pacing leads

Time frame: within 7 days after pacing procedure

impedances performances of left ventricle pacing leads

Time frame: within 7 days after pacing procedure

Complications rate at 6 month Follow up

Time frame: Visit 6 : 6-months after pacing procedure

Clinical benefit at 6 month Follow up: Gain in NYHA