- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00551681
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
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
-
-
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
|
epicardial left ventricular lead placement
|
Active Comparator: 2
transvenous left ventricular lead
|
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
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
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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