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

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

Interventions

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

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS)

  collaborator UNKNOWN

• Thoratec Corporation

  collaborator INDUSTRY

• Thoratec Europe Ltd

  collaborator INDUSTRY

• Abbott Medical Devices

  lead INDUSTRY

Principal Investigators

• Bart Meyns, MD/PhD · Leuven Gasthuisberg University Hospital

• Luc-Marie Jacquet, MD/PhD · Cliniques Universitaires St Luc

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• Belgium

Study Locations