Non-Invasive Venous Waveform Analysis (NIVA) in patients with Heart Failure (HF)

项目摘要 容量超负荷(充血)发生在心力衰竭(HF)患者中，是主要原因 世界各地老年人住院人数的增加。不幸的是，临床症状和体征； 实验室价值；现有诊断工具在提供准确评估方面不可靠 卷状态。利用独特的生理信号，无创静脉波形分析 (NIVA)，VoluMetrix开发了一种专有设备和算法，旨在监控 心衰患者的容量状态。人类和实验动物的概念验证数据 模型表明，NIVA提供了血管内容量状态的可靠指示 (“肺毛细血管楔形当量”)。此阶段IIB提案中的工作将建立 接口和可用性研究，以完成弥合差距所需的流程 商业化。

Project Summary Volume overload (congestion) occurs in patients with heart failure (HF) and is the leading cause of hospitalization in the elderly worldwide. Unfortunately, clinical signs and symptoms; laboratory values; and existing diagnostic tools are unreliable in providing accurate assessment of volume status. Using a unique physiologic signal, Non-Invasive Venous waveform Analysis (NIVA), VoluMetrix has developed a proprietary device and algorithm designed for monitoring volume status in HF patients. Proof of concept data in humans and experimental animal models, demonstrate that NIVA provides a reliable indication of intravascular volume status (“pulmonary capillary wedge equivalent”). The work in this Phase IIB proposal will establish interface and usability studies to complete the process necessary for bridging the gap to commercialization.