Development and Clinical Testing of CorAide RVAD/BVAD

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DESCRIPTION (provided by applicant): The use of implantable left ventricular assist devices (LVADs) has been increasing to serve the growing population of patients with end-stage congestive heart failure. However, up to 40% of patients have significant right ventricular (RV) failure that limits the utility of implantable LVAD therapy. RV failure leads to two problems: decreased forward flow and high right heart pressures that result in passive congestion of the liver, kidneys, and abdominal organs. Both factors contribute to multiorgan failure, the leading cause of death after LVAD implant. Such patients commonly require prolonged inotropic support or support with a right ventricular assist device (RVAD). Clinically available RVADs are not implantable devices and have several limitations due to poor blood compatibility, high infection rates, poor long-term durability, need for anticoagulation, need for a hospital stay, high mortality, and a less than ideal quality of life. We have reported a poor prognosis in patients with LVAD support who also required external RVAD support or prolonged inotropic support. A safe, effective, implantable RVAD could save the lives of many such patients with RV failure. We have developed the CorAide TM LVD-4000 Assist System, which is based on an implantable, third generation, centrifugal pump. A rotating assembly is fully suspended without mechanical contact or wear during operation. If the CorAide LVAD can be modified and used as an RVAD, the resulting CorAide biventricular ventricular assist device (BVAD) will be an ideal system for permanent support (destination therapy). The main objectives of this proposed program are to design, develop, and clinically evaluate an implantable RVAD that can be used as a component of an implantable BVAD for patients with severe biventricular failure. The specific aims are (1) Design and develop an implantable RVAD based on the CorAide LVAD, third generation centrifugal blood pump, (2) Design and develop an advanced fail-safe control algorithm capable of fixed speed or automatic mode that balances RVAD and LVAD performance, (3) Undertake in vivo characterization testing of the system both as an isolated RVAD and as a BVAD with the CorAide LVAD, (4) Undertake in vivo and in vitro reliability testing of the complete RVAD system, and (5) Obtain FDA approval for Investigational Device Exemption (IDE) and undertake clinical pilot studies using an institutionally approved program for patient selection and data collection. In this proposal, we will design and develop an RVAD in the first year, perform the characterization study in the second year, perform in vivo and in vitro reliability studies in the second and third years, and perform a clinical trial in the fourth and fifth years. The successful completion of this program will provide clinicians and patients with a safe and effective option for outpatient mechanical support that allows an excellent quality of life.