Heart Failure at NYHA Stage III or IVCHECKMATENCT01126944
LVAD in Non Cardiac Transplant Candidates and Non Responders to Resynchronization
A study testing heart mate II in people with Heart Failure at NYHA Stage III or IV and Non Responders to Resynchronization, run by Rennes University Hospital at 4 sites in 2 countries.
Trial summary
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization, Non Candidates for Transplantation
- What is being tested?
- heart mate II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2010to Dec 2013
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with heart failure class III or IV NYHA
- LVEF < 35%
- resynchronization for at least 6 months
- non eligibility for cardiac transplant
- operability and psychological criteria assessed
Who cannot join
- Patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device
- Patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation
- Patients with acute decompensated cardiac insufficiency at the time of randomisation
- Patients whose body surface area is below 1.2m²
- Patients with a mechanical cardiac valve
- Patients requiring associated aortic or mitral surgery
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- Patients with an active uncontrolled infection
- Patients with a severe pulmonary respiratory pathology
- Patients with contra-indications for or an intolerance to anti-coagulants or platelet anti-aggregants
- Presence of risk factors or indicators of visceral failure (severe COPD, renal insufficiency with dialysis, hepatic insufficiency with cholestasis…)
- Patients with a Lietz/Miller operating mortality score ≥ "high risk"
- Patients with an elevated risk of an embolism and atrial intra-cardiac thrombus
- Severe right ventricular failure (echography and right cardiac catheter examination) with the probable need for right ventricular mechanical assistance
- Patients who are candidates for coronary revascularisation
- Participation in another study which may interact with the proposed clinical trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
France3 sites
La Timone Hospital
Marseille
La Pitié Salpétrière Hospital
Paris
University Hospital
Rennes
Germany1 site
Klinik für Herz- und Thoraxchirurgie Martin-Luther-Universität
Halle
About this study
Official title: Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).
It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.
Read more
Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.
The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.
- Conditions
- Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization, Non Candidates for Transplantation
- Being tested
- heart mate II
- Keywords
- heart failure, resynchronization, left ventricular assist device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart mate IIDevice
left ventricular assist device
| Study group | Role | What they receive |
|---|---|---|
| system heart mate II | Experimental | left ventricular assist device Receives: Device: heart mate II |
| normal medical care | No intervention | Optimal medical treatment for heart failure according to international guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life : minnesota living with heart failure
Measured: one year
Secondary outcomes (1)
6 mn walk test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: No patients recruted since recruiting is open
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure at NYHA Stage III or IVStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thoratec Europe Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126944
- Sponsor's protocol ID
- LOC/09-03
- Acronym
- CHECKMATE
- Status last verified
- Sep 2010
- First submitted
- 18 May 2010
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Congestive Heart Failure Through the Evaluation of Cardiac Resynchronization Non-responders and Mechanical Assistance Therapy
- ClinicalTrials.gov ID
- NCT01126944
- Acronym / sponsor ID
- CHECKMATE / LOC/09-03
- Conditions
- Heart Failure at NYHA Stage III or IV, Non Responders to Resynchronization, Non Candidates for Transplantation
- Keywords
- heart failure, resynchronization, left ventricular assist device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruted since recruiting is open
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Thoratec Europe Ltd
- Study start
- Mar 2010
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 May 2010 (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.
The prognosis for heart failure patients is bleak for the advanced stages of the disease, with a reported 6-month mortality rate of almost 50% in patients treated with chronic inotropic therapy. As well as its very severe prognosis, heart failure is a costly disease. Heart transplantation remains the reference treatment for the terminal stage of the disease but although this is an effective therapy, it does engender ethical, social, economic and legal problems. It also requires irreproachable and costly logistics, immuno-suppressor treatment and a lifetime of follow-ups. In particular, the number of donors has been going down steadily for several years in most countries which offer a heart transplant programme and some patients cannot take advantage of being added to a waiting list for a graft (age, co-morbidities…).
It is in this context that, alongside the medical treatments for cardiac insufficiency, other therapeutic strategies were developed, including resynchronization and long-term mechanical circulatory support. The progress made in resynchronization is at several levels: better understanding of the action mechanisms, the development and improvement of equipment specifically dedicated to resynchronization and prospective and randomized clinical trials which have scientifically validated this technique.
Simultaneously, many studies were published evaluating long term support with mechanical circulatory support (MCS), excluding light devices, as a bridge to transplant or an alternative to a transplant. It is also recognized that mechanical circulatory support with a new generation of continuous flow assist device improved the quality of life and functional capacity, with a reduced risk of device failure and infrequent need for replacement.
The "Achilles heel" of cardiac resynchronization remains the 20 to 40% of patients who respond barely or not at all. Among this population of patients, some are not candidates for a transplantation and long-term mechanical circulatory support by axial pump is an alternative to be considered. We elaborated an original randomized pilot study for these patients in order to evaluate their survival and their quality of life, to define if they should be proposed a left ventricular assist device (LVAD)or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| system heart mate II | Experimental | Device: heart mate IIleft ventricular assist device |
| normal medical care | No intervention | –Optimal medical treatment for heart failure according to international guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with heart failure class III or IV NYHA
- LVEF < 35%
- resynchronization for at least 6 months
- non eligibility for cardiac transplant
- operability and psychological criteria assessed
Key exclusion criteria (15 listed)
- Patients incapable of understanding the proposed procedure, its risks and potential benefits or the consequences engendered by the permanent implanting of a left ventricular assist device
- Patients on mechanical circulatory support, including an intra-aortic counter-pulsion balloon, at the time of randomisation
- Patients with acute decompensated cardiac insufficiency at the time of randomisation
- Patients whose body surface area is below 1.2m²
- Patients with a mechanical cardiac valve
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 |
|---|---|---|
| heart mate IIleft ventricular assist device | Device | system heart mate II |
Primary outcome
quality of life : minnesota living with heart failure
Time frame: one year
1 secondary outcome
6 mn walk test
Time frame: one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart mate II in people with Heart Failure at NYHA Stage III or IV and Non Responders to Resynchronization, run by Rennes University Hospital at 4 sites in 2 countries.
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 15 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: withdrawn, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France, Germany. 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 was withdrawn before enrolling participants, so there are no results.
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?
quality of life : minnesota living with heart failure (time frame: one year). 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 13 Apr 2023.