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

R&D Cardiologie

Status: Completed

Conditions: Heart Failure; Left Ventricular Dysfunction

Treatments: Device: biventricular pacemaker with epicardial left ventricular lead; Device: transvenous left ventricular lead placement

Study type: Interventional

Funder types: Other

Identifiers

NCT00551681

RDC-2006-04

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

1

Active Comparator group

Description:

Epicardial left ventricular lead placement

Treatment:

Device: biventricular pacemaker with epicardial left ventricular lead

2

Active Comparator group

Description:

transvenous left ventricular lead

Treatment:

Device: transvenous left ventricular lead placement