Heart Failure, Left Ventricular Dysfunction
Conditions
Keywords
cardiac resynchronisation therapy, epicardial lead, coronary sinus
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.
Interventions
DEVICEbiventricular pacemaker with epicardial left ventricular lead
epicardial left ventricular lead placement
DEVICEtransvenous left ventricular lead placement
implantation of biventricular pacemaker with transvenous left ventricular lead placement
Sponsors
R&D Cardiologie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement | 6 months |
Secondary
| Measure | 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 |
Countries
Netherlands
Outcome results
None listed