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

April 20, 2016 updated by: Vincent van Dijk, R&D Cardiologie
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Utrecht
      • Nieuwegein, Utrecht, Netherlands, 3435 CM
        • St Antonius hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Epicardial left ventricular lead placement
Device: biventricular pacemaker with epicardial left ventricular lead
epicardial left ventricular lead placement
Active Comparator: 2
transvenous left ventricular lead
Device: transvenous left ventricular lead placement
implantation of biventricular pacemaker with transvenous left ventricular lead placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R&D Cardiologie

Investigators

  • Principal Investigator: Lucas VA Boersma, MD, PhD, St. Antonius Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 30, 2007

First Submitted That Met QC Criteria

October 30, 2007

First Posted (Estimate)

October 31, 2007

Study Record Updates

Last Update Posted (Estimate)

April 21, 2016

Last Update Submitted That Met QC Criteria

April 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-2006-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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