Clinical Investigation of the DeBakey VAD with Comparison to a Performance Goal to Establish Safety and Effectiveness of the Device as a Left Ventricular Support in Patients Awaiting Cardiac Transplantation
Patients with end-stage heart failure have limited options for treatment. Those patients awaiting cardiac transplantation whose condition deteriorates are placed on the highest priority UNOS (United Network of Organ Sharing) 1A list. For those patients who remain unstable despite maximal pharmacologic treatment, mechanical support with a left ventricular assist device (LVAD) may be indicated.
The DeBakey VAD represents a new generation of devices. This axial flow pump was developed to provide a ventricular assist device with adequate output, and is small, lightweight, and mechanically simple. Due to its small size and mechanical simplicity, the DeBakey VAD system may provide benefits not currently available with existing technology.
The purpose of this study is to determine the effectiveness and safety of the DeBakey VAD in providing circulatory support as a bridge to cardiac transplantation for UNOS 1A patients who are at risk of imminent death from non-reversible left ventricular failure.
We are one of 20 centers conducting this study in the United States. This is a multi-center, prospective, single arm study. All participants will be followed until cardiac transplantation. To learn more regarding the DeBakey VAD visit micromedtech.com.
Eligibility for enrollment
- Age 18 or older.
- Listed with UNOS on the Status 1A list.
- Patient for whom LVAD implantation is planned as bridge to cardiac transplantation as determined by the institution’s multidisciplinary transplant committee.
Primary Investigator: Vaughn Starnes, MD
Co-Investigators: Mark Cunningham, MD, Mark Barr, MD
Sponsor: MicroMed Technologies, Inc.
If you are interested in participating, please contact us at (323) 442-5849 to see if you qualify.
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