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

R&D Cardiologie52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Left Ventricular Dysfunction Heart Failure

Interventions

biventricular pacemaker with epicardial left ventricular leadDEVICE

epicardial left ventricular lead placement

transvenous left ventricular lead placementDEVICE

implantation of biventricular pacemaker with transvenous left ventricular lead placement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

St Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Outcomes

Primary Outcomes

Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement

Time frame: 6 months

Secondary Outcomes

Resynchronization of the LV, measured with TDI, 2D- and 3D-echocardiography, in patients with epicardial LV lead placement, compared to transvenous LV lead placement

Time frame: 6 months

Data from ClinicalTrials.gov

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