Back to resultsEffects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure (CONTRACT)
Primary Purpose
Left Ventricular Dysfunction, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
biventricular pacemaker with epicardial left ventricular lead
transvenous left ventricular lead placement
Sponsored by
About this trial
This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring cardiac resynchronisation therapy, epicardial lead, coronary sinus
Eligibility Criteria
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.
Sites / Locations
- St Antonius Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Epicardial left ventricular lead placement
transvenous left ventricular lead
Outcomes
Primary Outcome Measures
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
Secondary Outcome 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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551681
Brief Title
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
Acronym
CONTRACT
Official Title
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
R&D Cardiologie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction, Heart Failure
Keywords
cardiac resynchronisation therapy, epicardial lead, coronary sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Epicardial left ventricular lead placement
Arm Title
2
Arm Type
Active Comparator
Arm Description
transvenous left ventricular lead
Intervention Type
Device
Intervention Name(s)
biventricular pacemaker with epicardial left ventricular lead
Intervention Description
epicardial left ventricular lead placement
Intervention Type
Device
Intervention Name(s)
transvenous left ventricular lead placement
Intervention Description
implantation of biventricular pacemaker with transvenous left ventricular lead placement
Primary Outcome Measure Information:
Title
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas VA Boersma, MD, PHD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
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