Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure

Study Overview
=================
Brief Summary
-----------------
To compare a surgical approach of LV lead placement for BIV pacing with the conventional transvenous approach by assessment of differences on the effects on cardiac perfusion and relate this to the clinical cardiac function.

Official Title
-----------------
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure

Conditions
-----------------
Left Ventricular Dysfunction, Heart Failure

Intervention / Treatment
-----------------
* Device: biventricular pacemaker with epicardial left ventricular lead
* Device: transvenous left ventricular lead placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure NYHA III or IV QRS duration >120msec or, when paced > 200msec on 12-lead ECG LBBB on ecg LV ejection fraction 35% or less LV dyssynchony on echocardiography Exclusion Criteria: Severe (drug refractory) heart failure with short (<6 months) life expectancy. Permanent or persistent atrial fibrillation Other indications for cardiac surgery within 6 months Life expectancy less than one year due to other conditions Major contra-indication for general anaesthesia Participation in another study Pregnancy or the desire to become pregnant during the follow up of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Epicardial left ventricular lead placement | Device: biventricular pacemaker with epicardial left ventricular lead<br>* epicardial left ventricular lead placement<br>|
| Active Comparator: 2<br>transvenous left ventricular lead | Device: transvenous left ventricular lead placement<br>* implantation of biventricular pacemaker with transvenous left ventricular lead placement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resynchronization of the LV, measured with TDI, 2D- and 3D-echocardiography, in patients with epicardial LV lead placement, compared to transvenous LV lead placement |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac resynchronisation therapy, epicardial lead, coronary sinus