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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01260402
Other study ID # CHUBX 2010/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2011
Est. completion date July 30, 2015

Study information

Verified date February 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date July 30, 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Resynchronization using a transeptal approach
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 approach
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

Locations

Country Name City State
France Cardiologic Hospital Haut l'évêque Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Implant success rate Visit 3 : implantation day, end of pacing procedure
Secondary number of left ventricular pacing sites assessed Visit 3 : implantation day, end of pacing procedure
Secondary Pacing Procedure duration Visit 3 : implantation day, end of pacing procedure
Secondary Per and post implantation complications rate Visit 4 : within 7 days after pacing procedure
Secondary Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for left ventricle ejection fraction within 7 days after pacing procedure
Secondary Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for mitral regurgitation within 7 days after pacing procedure
Secondary Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for atrioventricular asynchronism within 7 days after pacing procedure
Secondary Post implantation echocardiography comparing spontaneous rhythm and biventricular pacing for inter and intra-ventricular asynchronism within 7 days after pacing procedure
Secondary sensing performances of left ventricle pacing leads within 7 days after pacing procedure
Secondary pacing threshold performances of left ventricle pacing leads within 7 days after pacing procedure
Secondary impedances performances of left ventricle pacing leads within 7 days after pacing procedure
Secondary Complications rate at 6 month Follow up Visit 6 : 6-months after pacing procedure
Secondary Clinical benefit at 6 month Follow up: Gain in NYHA 6-months after pacing procedure
Secondary Clinical benefit at 6 month Follow up: 6 minutes walk test 6-months after pacing procedure
Secondary Clinical benefit at 6 month Follow up: quality of life questionnaire as compared to pre implantation 6-months after pacing procedure
Secondary Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricular Ejection Fraction 6-months after pacing procedure
Secondary Echocardiography at 6 month Follow up: as compared to pre implantation for Left Ventricle volumes 6-months after pacing procedure
Secondary Echocardiography at 6 month Follow up: as compared to pre implantation for mitral regurgitation 6-months after pacing procedure
Secondary Echocardiography at 6 month Follow up: as compared to pre implantation for atrioventricular asynchronism 6-months after pacing procedure
Secondary Echocardiography at 6 month Follow up: as compared to pre implantation for inter and intra-ventricular asynchronism 6-months after pacing procedure
Secondary sensing performances of Left Ventricle pacing leads at 6 month Follow up 6-months after pacing procedure
Secondary pacing threshold performances of Left Ventricle pacing leads at 6 month Follow up 6-months after pacing procedure
Secondary impedances performances of Left Ventricle pacing leads at 6 month Follow up 6-months after pacing procedure
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