Development and Clinical Testing of CorAide RVAD/BVAD

CorAide RVAD/BVAD 的开发和临床测试

• 批准号: 7070596
• 负责人: Kiyotaka Fukamachi
• 金额: $ 136.25万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-03 至 2009-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7070596
• 关键词: auxiliary heart prosthesis; biomaterial development /preparation; blood flow measurement; cardiovascular disorder therapy; circulatory assist; clinical research; clinical trials; computer program /software; computer system design /evaluation; congestive heart failure; cow; heart ventricle; hemodynamics; human subject; human therapy evaluation; implant; longitudinal human study; medical implant science; nonhuman therapy evaluation; patient oriented research

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.

描述（由申请人提供）：使用可植入的左心室辅助设备（LVADS）的使用已在增加，以服务于不断增长的终末期充血性心力衰竭的患者人群。但是，多达40％的患者患有明显的右心（RV）衰竭，从而限制了植入式LVAD治疗的效用。 RV失败导致了两个问题：向前流动减少和右心压力，导致肝脏，肾脏和腹部器官的被动充血。这两个因素都导致多机器人失败，这是LVAD植入物后死亡的主要原因。这样的患者通常需要使用右心室辅助装置（RVAD）长时间的肌力支撑或支撑。临床上可用的RVAD不是可植入的设备，并且由于血液兼容性差，高感染率，长期耐用性差，抗凝需求，住院住院需求，高死亡率和不理想的生活质量而受到多种限制。我们报道了LVAD支持患者的预后不良，他们还需要外部RVAD支持或延长正性肌力支持。安全，有效，可植入的RVAD可以挽救许多此类RV衰竭患者的生命。我们已经开发了Coraide TM LVD-4000辅助系统，该系统基于可植入的第三代离心泵。旋转组件在没有机械接触或操作过程中完全悬浮。如果可以对Coraide LVAD进行修改并用作RVAD，则由此产生的Coraide Bidecular室心辅助装置（BVAD）将是永久支持（目的地治疗）的理想系统。该提议的计划的主要目标是设计，开发和临床评估可植入的RVAD，该植入式RVAD可以用作严重双室衰竭患者的植入式BVAD的组成部分。 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)对完整的RVAD系统进行体内和体外可靠性测试，（5）获得FDA批准以进行研究设备豁免（IDE），并使用经过机构批准的患者选择和数据收集的机构批准的计划进行临床试验研究。 在该提案中，我们将在第一年设计和开发RVAD，在第二年进行特征研究，在第二和第三年进行体内和体外可靠性研究，并在第四和第五年进行临床试验。该计划的成功完成将为临床医生和患者提供门诊机械支持的安全有效的选择，从而允许出色的生活质量。