Left Ventricular DysfunctionCONTRACTNCT00551681
Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
A study testing biventricular pacemaker with epicardial left ventricular lead and transvenous left ventricular lead placement in people with Left Ventricular Dysfunction and Heart Failure, run by R&D Cardiologie at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Heart Failure
- What is being tested?
- biventricular pacemaker with epicardial left ventricular lead and transvenous left ventricular lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2007to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Left Ventricular Dysfunction, Heart Failure
- Being tested
- biventricular pacemaker with epicardial left ventricular lead, transvenous left ventricular lead placement
- Keywords
- cardiac resynchronisation therapy, epicardial lead, coronary sinus
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biventricular pacemaker with epicardial left ventricular leadDevice
epicardial left ventricular lead placement
transvenous left ventricular lead placementDevice
implantation of biventricular pacemaker with transvenous left ventricular lead placement
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Epicardial left ventricular lead placement Receives: Device: biventricular pacemaker with epicardial left ventricular lead |
| 2 | Active comparator | transvenous left ventricular lead Receives: Device: transvenous left ventricular lead placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- R&D Cardiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincent van Dijk, R&D Cardiologie
- Investigators
- Lucas VA Boersma, MD, PHD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551681
- Sponsor's protocol ID
- RDC-2006-04
- Acronym
- CONTRACT
- Status last verified
- Apr 2016
- First submitted
- 30 Oct 2007
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure
- ClinicalTrials.gov ID
- NCT00551681
- Acronym / sponsor ID
- CONTRACT / RDC-2006-04
- Conditions
- Left Ventricular Dysfunction, Heart Failure
- Keywords
- cardiac resynchronisation therapy, epicardial lead, coronary sinus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- R&D CardiologieUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Feb 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: biventricular pacemaker with epicardial left ventricular leadEpicardial left ventricular lead placement |
| 2 | Active comparator | Device: transvenous left ventricular lead placementtransvenous left ventricular lead |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biventricular pacemaker with epicardial left ventricular leadepicardial left ventricular lead placement | Device | 1 |
| transvenous left ventricular lead placementimplantation of biventricular pacemaker with transvenous left ventricular lead placement | Device | 2 |
Primary outcome
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement
Time frame: 6 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucas VA Boersma, MD, PHD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biventricular pacemaker with epicardial left ventricular lead and transvenous left ventricular lead placement in people with Left Ventricular Dysfunction and Heart Failure, run by R&D Cardiologie at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of change in cardiac perfusion following epicardial LV lead placement, compared to transvenous LV lead placement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.