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OpenTrials
Completed

NCT Number: NCT00551681

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

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.

Completed

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Key information

Conditions

Left Ventricular Dysfunction Cardiovascular Diseases Heart Diseases Heart Failure Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biventricular pacemaker with epicardial left ventricular lead

Device

epicardial left ventricular lead placement

transvenous left ventricular lead placement

Device

implantation of biventricular pacemaker with transvenous left ventricular lead placement

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

R&D Cardiologie

Other

Registry information

Acronym: CONTRACT

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Oct 31, 2007
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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