BeneMACS Study:HeartMate 2 (HM2)Left Ventricular Assist Device (LVAD) Survival in Non Transplant Patients is Equal/Better Than Results in Medical Literature

NCT00983190 | Completed

• 2 other identifiers: BeneMACS LVAD Study Rev 6Jan09B32220096329 - Belgium
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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 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

Conditions

Heart Failure

Keywords

HeartMate II; BeneMACS; LVAD; Thoratec Corporation

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (1)

Single Group Assignment

OTHER

Device: Left Ventricular Assist Device (HeartMate II)

Interventions

Left Ventricular Assist Device (HeartMate II) DEVICE

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

Also known as: HeartMate II, LVAD, HMII

Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead
• KU Leuven: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS): collaborator
• Thoratec Corporation: collaborator
• Thoratec Europe Ltd: collaborator

Study Sites (2)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

Leuven Gasthuisberg University Hospital

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Bart Meyns, MD/PhD

  Leuven Gasthuisberg University Hospital

  PRINCIPAL INVESTIGATOR

• Luc-Marie Jacquet, MD/PhD

  Cliniques Universitaires St Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 24, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 30, 2019

Record last verified: 2019-01

Locations

BE (2)