Status:
COMPLETED
BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
KU Leuven
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 th...
Detailed Description
1. 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 Belgiu...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00983190
Start Date
July 1 2009
End Date
May 1 2013
Last Update
January 30 2019
Active Locations (2)
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1
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
2
Leuven Gasthuisberg University Hospital
Leuven, Belgium, 3000