Heart FailureBeneMACsNCT00983190
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
A study testing Left Ventricular Assist Device (HeartMate II) in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Belgium.
Trial summary
Study Purpose The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Left Ventricular Assist Device (HeartMate II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesBelgium
- Study dates
- Jul 2009to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or their legal representative has signed an informed consent. > 18 years of age.
- BSA > 1.3m2.
- Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) On optimal medical management, including dietary salt restriction, diuretics, beta-blockers, spironolactone and ACE inhibitors, for at least 45 out of the last 60 days and are failing to respond; or In Class III or Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 5 days and/or inotropes for at least 10 days; or Treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant.
- Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- Ineligible for cardiac transplant.
- VO2max < 14 ml/kg/min or <50% of predicted VO2max with attainment of anaerobic threshold (AT), if not contra-indicated due to IV inotropes, angina or physical disability.
- LVEF is < 25%.
Who cannot join
- Etiology of heart failure is due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- Body Mass Index (BMI) > 40 kg/m2.
- Positive pregnancy test if female of childbearing age.
- Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant.
- History of cardiac transplant or cardiomyoplasty.
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- Platelet count < 50,000.
- Evidence of an untreated aortic aneurysm > 5cm.
- Psychiatric disease, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAD management.
- Presence of active, uncontrolled infection.
- Intolerance to anticoagulant or antiplatelet therapies or any other peri/post operative therapy the investigator will require based upon the patient's health status.
- INR > 2.5, which is not due to anti-coagulant therapy, or Plavix administration within 5 days.
- Evidence of intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) that are > 5 times the upper limit of normal, or biopsy proven liver cirrhosis.
- History of severe COPD or severe restrictive lung disease.
- Fixed pulmonary hypertension with a PVR > 8 Wood units that is unresponsive to pharmacological intervention.
- History of a stroke within 90 days prior to enrollment, or a history of cerebral vascular disease with significant (> 80%) extra cranial stenosis.
- Serum creatinine > 3.5 mg/dl or the need for chronic renal replacement therapy (e.g. chronic dialysis).
- Significant peripheral vascular disease accompanied by rest pain or extremity ulceration.
- The patient has moderate to severe aortic insufficiency without plans for correction during pump implantation surgery.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome.
- Any condition, other than heart failure, that is likely to limit survival to less than 3 years.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Cliniques Universitaires St Luc
Brussels, 1200
Leuven Gasthuisberg University Hospital
Leuven, 3000
About this study
Official title: HeartMate II BeneMACS Long Term LVAD Study
Study Purpose
The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. Implants will be performed following the HeartMate II guidelines.
Read more
Characterization of Patient Population The HeartMate II will be implanted as destination therapy in patients who are not candidates for cardiac transplantation.
Study Design
The study is a prospective, non-randomized, non-blinded multi-center study with historical control. The study will consist of the assignment of eligible patients to treatment with the LVAD. The first 10 patients to have the device implanted will be enrolled in the study.
Study End point
Patients enrolled in the study will be followed until end points defined as death, 2-year support on the HeartMate II, device removal, transplantation, or recovery.
Data Collection and Follow-up
All data will be entered into INTERMACS® through their web-based data entry system. All data for the BeneMACs study will be held separately from the main INTERMACS database, and used only for the purpose of the BeneMACs study.
Investigator sites
Cliniques Universitaires St. Luc, Avenue Hippocrates 10, 1200 Brussels, Belgium Leuven Gasthuisberg University Hospital, Herestraat 49, 3000 Leuven, Belgium
Read the detailed description
- STUDY OBJECTIVE The purpose of the BeneMACs Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. (see section 4.6.4) Implants will be performed following the HeartMate II guidelines.
- STUDY ENTRY CRITERIA - PATIENT SELECTION 2.1 Characterization of Patient Population The HeartMate II will be implanted as destination therapy in patients who are not candidates for cardiac transplantation.
- METHODS
3.1 Study Design
The study is a prospective, non-randomized, non-blinded multi-center study with historical control. The study will consist of the assignment of eligible patients to treatment with the LVAD. The first 10 patients to have the device implanted will be enrolled in the study.
3.2 Study End point
Patients enrolled in the study will be followed until end points defined as death, 2-year support on the HeartMate II, device removal, transplantation, or recovery.
3.3 Number of Clinical Sites and Patients
The study will be conducted at up to three (3) clinical sites. A total of 10 patients (3-4 patients per site) will be enrolled and implanted with the HM II.
3.4 Data Collection and Follow-up:
All data will be entered into INTERMACS® through their web-based data entry system. Complete documentation and the Site User's Guide are contained at the data entry website (www.intermacs.org). INTERMACS (the Interagency Registry of Mechanical Assisted Circulatory Support) was formed as a partnership between the National Heart Lung, and Blood Institute (NHLBI), the FDA, Centers for Medicare and Medicaid Services (CMS), participating hospitals and industry (reference 7.2). It is the main MCS registry in the United States. In addition to its primary purpose, the validated database used by INTERMACS is also being made available as a service to other studies of mechanical circulatory support devices such as the BeneMACs study.
All data for the BeneMACs study will be held separately from the main INTERMACS database, and used only for the purpose of the BeneMACs study.
- Conditions
- Heart Failure
- Being tested
- Left Ventricular Assist Device (HeartMate II)
- Keywords
- HeartMate II, BeneMACS, LVAD, Thoratec Corporation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left Ventricular Assist Device (HeartMate II)Device
Also called HeartMate II, LVAD, HMII
The HM II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via rigid inlet cannulae and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastamosis. Power and control of the pump are delivered through a percutaneous cable from pump to the belt-worn System Controller. The System Controller will receive power from the Power Base Unit (PBU), or two battery modules that may be worn in shoulder holsters or on the belt
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Other | Not described Receives: Device: Left Ventricular Assist Device (HeartMate II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study will assign patients to treatment with an HMII LVAD. Ten patients will be enrolled in the study. Patients enrolled in the study will be followed until end points defined as 2year support on device, device removal, transplantation recovery, or death
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2013
- Study completionMay 2013
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 Abbott Medical DevicesThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS), Thoratec Corporation, Thoratec Europe Ltd
- Responsible party
- Sponsor
- Investigators
- Bart Meyns, MD/PhD, Principal investigator, Leuven Gasthuisberg University HospitalLuc-Marie Jacquet, MD/PhD, Principal investigator, Cliniques Universitaires St Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983190
- Sponsor's protocol ID
- BeneMACS LVAD Study Rev 6Jan09
- Other IDs
- B32220096329 - Belgium
- Acronym
- BeneMACs
- Status last verified
- Jan 2019
- First submitted
- 22 Sep 2009
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HeartMate II BeneMACS Long Term LVAD Study
- ClinicalTrials.gov ID
- NCT00983190
- Acronym / sponsor ID
- BeneMACs / BeneMACS LVAD Study Rev 6Jan09
- Conditions
- Heart Failure
- Keywords
- HeartMate II, BeneMACS, LVAD, Thoratec Corporation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- KU Leuven, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS), Thoratec Corporation, Thoratec Europe Ltd
- Study start
- Jul 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Sep 2009 (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.
Study Purpose
The purpose of the BeneMACS Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. Implants will be performed following the HeartMate II guidelines.
Characterization of Patient Population The HeartMate II will be implanted as destination therapy in patients who are not candidates for cardiac transplantation.
Study Design
The study is a prospective, non-randomized, non-blinded multi-center study with historical control. The study will consist of the assignment of eligible patients to treatment with the LVAD. The first 10 patients to have the device implanted will be enrolled in the study.
Study End point
Patients enrolled in the study will be followed until end points defined as death, 2-year support on the HeartMate II, device removal, transplantation, or recovery.
Data Collection and Follow-up
All data will be entered into INTERMACS® through their web-based data entry system. All data for the BeneMACs study will be held separately from the main INTERMACS database, and used only for the purpose of the BeneMACs study.
Investigator sites
Cliniques Universitaires St. Luc, Avenue Hippocrates 10, 1200 Brussels, Belgium Leuven Gasthuisberg University Hospital, Herestraat 49, 3000 Leuven, Belgium
Detailed description
- STUDY OBJECTIVE The purpose of the BeneMACs Long-Term LVAD Study is to demonstrate that survival in non transplant patients implanted with the HeartMate II LVAD as destination therapy in Belgium and the Netherlands are equivalent to or better than published results in the scientific literature with approved devices. (see section 4.6.4) Implants will be performed following the HeartMate II guidelines.
- STUDY ENTRY CRITERIA - PATIENT SELECTION 2.1 Characterization of Patient Population The HeartMate II will be implanted as destination therapy in patients who are not candidates for cardiac transplantation.
- METHODS
3.1 Study Design
The study is a prospective, non-randomized, non-blinded multi-center study with historical control. The study will consist of the assignment of eligible patients to treatment with the LVAD. The first 10 patients to have the device implanted will be enrolled in the study.
3.2 Study End point
Patients enrolled in the study will be followed until end points defined as death, 2-year support on the HeartMate II, device removal, transplantation, or recovery.
3.3 Number of Clinical Sites and Patients
The study will be conducted at up to three (3) clinical sites. A total of 10 patients (3-4 patients per site) will be enrolled and implanted with the HM II.
3.4 Data Collection and Follow-up:
All data will be entered into INTERMACS® through their web-based data entry system. Complete documentation and the Site User's Guide are contained at the data entry website (www.intermacs.org). INTERMACS (the Interagency Registry of Mechanical Assisted Circulatory Support) was formed as a partnership between the National Heart Lung, and Blood Institute (NHLBI), the FDA, Centers for Medicare and Medicaid Services (CMS), participating hospitals and industry (reference 7.2). It is the main MCS registry in the United States. In addition to its primary purpose, the validated database used by INTERMACS is also being made available as a service to other studies of mechanical circulatory support devices such as the BeneMACs study.
All data for the BeneMACs study will be held separately from the main INTERMACS database, and used only for the purpose of the BeneMACs study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Other | Device: Left Ventricular Assist Device (HeartMate II) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient or their legal representative has signed an informed consent. > 18 years of age.
- BSA > 1.3m2.
- Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) On optimal medical management, including dietary salt restriction, diuretics, beta-blockers, spironolactone and ACE inhibitors, for at least 45 out of the last 60 days and are failing to respond; or In Class III or Class IV heart failure for at least 14 days, and dependent on intra aortic balloon pump (IABP) for 5 days and/or inotropes for at least 10 days; or Treated with ACE inhibitors or beta-blockers for at least 30 days and found to be intolerant.
- Female patients of childbearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) for the duration of the study.
- Ineligible for cardiac transplant.
Key exclusion criteria (21 listed)
- Etiology of heart failure is due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, active myocarditis or restrictive cardiomyopathy.
- Technical obstacles, which pose an inordinately high surgical risk, in the judgment of the investigator.
- Body Mass Index (BMI) > 40 kg/m2.
- Positive pregnancy test if female of childbearing age.
- Presence of mechanical aortic valve that will not be converted to a bioprosthesis at time of LVAD implant.
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 Assist Device (HeartMate II)Also: HeartMate II, LVAD, HMIIThe HM II is a high speed, electric, axial flow, rotary blood pump. The pump drains blood from the left ventricular apex via rigid inlet cannulae and ejects into the aortic root via an outflow cannula joined to the aorta with an end to side anastamosis. Power and control of the pump are delivered through a percutaneous cable from pump to the belt-worn System Controller. The System Controller will receive power from the Power Base Unit (PBU), or two battery modules that may be worn in shoulder holsters or on the belt | Device | Single Group Assignment |
Primary outcome
Study will assign patients to treatment with an HMII LVAD. Ten patients will be enrolled in the study. Patients enrolled in the study will be followed until end points defined as 2year support on device, device removal, transplantation recovery, or death
Time frame: 2 years
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 30 Jan 2019.
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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.
Bart Meyns, MD/PhD principal investigator
Leuven Gasthuisberg University Hospital
Luc-Marie Jacquet, MD/PhD principal investigator
Cliniques Universitaires St Luc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left Ventricular Assist Device (HeartMate II) in people with Heart Failure, run by Abbott Medical Devices at 2 sites in Belgium.
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 7 inclusion and 21 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Study will assign patients to treatment with an HMII LVAD. Ten patients will be enrolled in the study. Patients enrolled in the study will be followed until end points defined as 2year support on device, device removal, transplantation recovery, or death (time frame: 2 years). 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 30 Jan 2019.