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

University Hospital of Bordeaux

Status: Completed

Conditions: Cardiomyopathy, Dilated; Heart Failure; Coronary Disease

Treatments: Device: Resynchronization using a transeptal approach; Device: Resynchronization using a coronary sinus approach

Study type: Interventional

Funder types: Other

Identifiers

NCT01260402

CHUBX 2010/12

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Epicardial

Active Comparator group

Treatment:

Device: Resynchronization using a coronary sinus approach

Endocardial

Experimental group

Treatment:

Device: Resynchronization using a transeptal approach