Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00772-37 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epicardial | Active Comparator |
| |
| Endocardial | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resynchronization using a transeptal approach | Device | 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 |
| 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 |
| Measure | Description | 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pierre JAIS, MD | University Hospital Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiologic Hospital Haut l'évêque | Pessac | 33604 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29889232 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Resynchronization using a coronary sinus approach | Device | 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 |
|
| 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 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002311 | Cardiomyopathy, Dilated |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017202 | Myocardial Ischemia |
| D014652 | Vascular Diseases |
Not provided
Not provided