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 全世界老年人的住院率。不幸的是，临床体征和症状; 实验室值;现有的诊断工具在提供准确评估方面不可靠 卷的状态。使用独特的生理信号，无创静脉波形分析 （尼瓦），VolumMeetings开发了一种专为监测而设计的专有设备和算法 HF患者的容量状态。人类和实验动物的概念验证数据 模型，证明尼瓦提供了血管内容量状态的可靠指示 （“肺毛细血管楔状当量”）。本阶段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过程， 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.