Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.
- Conditions
- Cardiomyopathy, DilatedHeart FailureCoronary Disease
- Interventions
- Device: Resynchronization using a coronary sinus approachDevice: Resynchronization using a transeptal approach
- Registration Number
- NCT01260402
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epicardial Resynchronization using a coronary sinus approach - Endocardial Resynchronization using a transeptal approach -
- Primary Outcome Measures
Name Time Method the acute hemodynamic response judged by dP/dt max 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cardiologic Hospital Haut l'Ć©vĆŖque
š«š·Pessac, France