NCT01260402

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2011-03-03
• Primary completion: 2015-01-01
• Completion: 2015-07-30
• First posted: 2010-12-15
• Last updated: 2022-02-25

Locations

1 site across 1 country: France