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

NCT ID: NCT01260402

Last Updated: 2022-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-03
• Study Completion Date: 2015-07-30

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.

Conditions

Heart Failure; Cardiomyopathy, Dilated; Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epicardial

Group Type: ACTIVE_COMPARATOR

Resynchronization using a coronary sinus approach

Intervention Type: 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

Endocardial

Group Type: EXPERIMENTAL

Resynchronization using a transeptal approach

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre JAIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

Cardiologic Hospital Haut l'évêque

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2010/12

Identifier Type: -

Identifier Source: org_study_id