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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2015

Interventions

  • Device: biventricular pacemaker with epicardial left ventricular lead
    • epicardial left ventricular lead placement
  • Device: transvenous left ventricular lead placement
    • implantation of biventricular pacemaker with transvenous left ventricular lead placement

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Epicardial left ventricular lead placement
  • Active Comparator: 2
    • transvenous left ventricular lead

Clinical Trial Outcome Measures

Primary Measures

  • Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
    • Time Frame: 6 months

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • R&D Cardiologie
  • Provider of Information About this Clinical Study
    • Principal Investigator: Vincent van Dijk, MD – R&D Cardiologie
  • Overall Official(s)
    • Lucas VA Boersma, MD, PHD, Principal Investigator, St. Antonius Hospital

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