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

Heart Failure Clinical Trial

— EPI-ENDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260402
• Other study ID #: CHUBX 2010/12
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Coronary Artery Disease
• Coronary Disease
• Heart Failure

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