NCT00983190

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

HeartMate II BeneMACS Long Term LVAD Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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 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. 2. 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. 3. 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

Interventions

Type	Name	Description
DEVICE	Left Ventricular Assist Device (HeartMate II)	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

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2009-09-24
• Last updated: 2019-01-30

Locations

2 sites across 1 country: Belgium