Physiological Controller for Rotary Blood Pumps

描述（由申请人提供）：旋转血泵的竞争持续拨款申请生理控制器旋转血泵因其体积小，可靠性和能效而在机械循环支持领域迅速获得青睐。然而，由于这些泵对循环负荷的敏感性和在负压下抽血的能力，其控制存在一些困难。在I期和II期的研究中，我们开发了先进的算法，通过开发适用于旋转心室辅助装置的算法来模拟血流和压力的生理控制，并在WorldHeart Levacor VAD系统上进行了具体测试。在这个关键时刻，需要额外的验证测试和验证，以满足监管要求，以便这些控制改进可以提供给接受VAD治疗的患者。拨款申请的具体目的如下：1)使用Levacor VAD系统实现控制器。2)进行临床前动物实验。3)完成初始临床试验。4)准备向FDA提交关键临床试验。拨款申请中建议进行6个为期30天的动物实验，以证明该控制器在动物模型中的安全性和有效性。本文描述了临床试验方案，以评估假阳性检测的反抽吸控制以及对抽吸事件的肯定反应。作为试验的一部分，还提出了评估患者康复和运动反应的方案。试验的成功将通过以下几个方面来证明：1)通过实施自动控制，患者的净风险降低；2)恢复的设备测量与独立测量的恢复临床标志物之间的相关性；3)通过增强对运动的反应，患者的生活质量得到改善。

DESCRIPTION (provided by applicant): Competing Continuation Grant Application Physiologic Controller for Rotary Blood Pumps Rotary blood pumps are rapidly gaining favor in the field of mechanical circulatory support because of their small size, reliability, and energy efficiency. However the control of these pumps presents some difficulties because of their sensitivity to circulatory load and ability to draw blood under negative pressure. In a Phase I and Phase II effort, we have developed advanced algorithms to mimic the physiological control of blood flow and pressure by developing algorithms suitable for rotary ventricular assist devices, and specifically testing them on the WorldHeart Levacor" VAD system. At this juncture, additional verification testing and validation is required to meet regulatory requirements so that these control improvements may be provided to patients receiving VAD therapy. The specific aims for the grant application are as follows: 1) Implement the controller with the Levacor VAD" system. 2) Conduct preclinical animal studies. 3) Complete an Initial Clinical Trial. 4) Prepare submission to FDA for the Pivotal clinical trial. Preclinical tests are proposed in the grant application for six 30-day animal experiments that will prove safety and effectiveness of the controller in an animal model. Protocols for clinical tests are described to evaluate anti-suction control for false positive detection as well as affirmative response to suction events. Protocols for evaluation of patient recovery and for response to exercise are also proposed as part of the trial. Success of the trial will be demonstrated by, 1) a net decrease in risk to patients by implementation of the automatic control, 2) correlation of device measurements of recovery to independently measured clinical markers for recovery, and 3) improved quality of life for patients by enhanced response to exercise. PUBLIC HEALTH RELEVANCE: Physiologic Controller for Rotary Blood Pumps Physiologically responsive control software for an implantable rotary blood pump has been developed in Phase I and Phase II SBIR programs. The objective of this proposed program is to complete rigorous testing that is required for FDA approval, and begin use of the controller in people.