Heart FailureNCT00221780
Role of Left Ventricular Pacing Site
A study testing left ventricular pacing in people with Heart Failure and Cardiomyopathy, Dilated, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- What is being tested?
- left ventricular pacing
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Dec 2007
- 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 referred for cardiac resynchronization therapy
- NYHA Class III or IV
- Informed consent form signed
Who cannot join
- Hypertension not controlled by treatment
- Coronary ischemia not controlled by treatment
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Cardiologique du Haut Lévêque, Rythmology department, Pr CLEMENTY, 3rd Floor
Pessac, 33604
Pierre Jaïs, Dr, 33 (0) 5 57 65 64 71, pierre.jais@chu-bordeaux.fr
Pierre Jaïs, Dr
About this study
Official title: Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.
Read the detailed description
Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.
Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.
Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.
Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure
Outcomes. Hemodynamic measures using pressure-volume catheters.
- Conditions
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- Being tested
- left ventricular pacing
- Keywords
- Heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, Hemodynamics, Randomized Controlled Trials, Single-Blind Study
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left ventricular pacingDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in left ventricular dp/dt max
Secondary outcomes (3)
pressures and volumes of the left ventricle
stroke work
surface ECG repolarisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2003
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Investigators
- Pierre Jaïs, Dr, Principal investigator, University Hospital, BordeauxPaul Perez, Dr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221780
- Sponsor's protocol ID
- 9426-01
- Other IDs
- 2001-030
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 29 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Left Ventricular Pacing Site in Biventricular Resynchronization Therapy for Severe Heart Failure
- ClinicalTrials.gov ID
- NCT00221780
- Acronym / sponsor ID
- 9426-01
- Conditions
- Heart Failure, Cardiomyopathy, Dilated, Coronary Disease
- Keywords
- Heart failure, Cardiomyopathy, dilated, Coronary disease, Cardiac Pacing, Artificial, Hemodynamics, Randomized Controlled Trials, Single-Blind Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Nov 2003
- Study completion
- Dec 2007 (estimated)
- First posted
- 22 Sep 2005 (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.
Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site. We study in a random order 11 different left ventricular pacing sites and compare their hemodynamics using pressure-volume catheters. The consequences on the surface ECG are also assessed.
Detailed description
Background. Cardiac resynchronization therapy has been shown to be effective in reducing symptoms and mortality in heart failure patients. However, very few is known about the importance of the left ventricular pacing site.
Design. Single-blind, monocentric, randomized cross-over study comparing 11 left ventricular pacing sites in a random order.
Intervention. Left ventricular DDD pacing on 11 ventricular sites, prior to the implantation. At each pacing site, a control hemodynamics will be obtained in AAI pacing at the same pacing rate. At each pacing site, 2 AV delays, a short and a long one, will be assessed.
Eligibility criteria. Patients referred for cardiac resynchronization therapy for heart failure
Outcomes. Hemodynamic measures using pressure-volume catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Heart failure referred for cardiac resynchronization therapy
- NYHA Class III or IV
- Informed consent form signed
Key exclusion criteria (2 listed)
- Hypertension not controlled by treatment
- Coronary ischemia not controlled by treatment
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 |
|---|---|---|
| left ventricular pacing | Device | – |
Primary outcome
Variation in left ventricular dp/dt max
3 secondary outcomes
pressures and volumes of the left ventricle
stroke work
surface ECG repolarisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2007.
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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.
Pierre Jaïs, Dr principal investigator
University Hospital, Bordeaux
Paul Perez, Dr study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left ventricular pacing in people with Heart Failure and Cardiomyopathy, Dilated, run by University Hospital, Bordeaux at 1 site in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jun 2007. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Jaïs, Dr (33 (0) 5 57 65 64 71, pierre.jais@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in left ventricular dp/dt max. 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 29 Jun 2007.