PD2i ANALYSIS OF R-R INTERVALS IN HIGH-RISK ER PATIENTS

描述（由申请人提供）：医疗市场上存在大量未满足的产品，以协助急诊科医生对高危心脏病患者进行快速分诊。提出了一种新的尖端设备，以减少医生的错误和医院的成本。第一阶段的目标是开发用户友好的分析软件，用于传统的数字心电，以预测心律失常死亡的风险。该建议得到了两项独立前瞻性研究结果的支持，这两项研究表明，该公司专有算法对心率变异性（HRV）的分析可以高度预测急诊患者的心律失常死亡和心肌梗死幸存者的全因死亡率。利用这种专有算法进行心电分析目前需要信号分析方面的专家。本提案的目标是开发符合FDA规范的软件，可供实际医院人员在实际临床情况下使用。这一快速通道提案的两个具体目标是：(1)

DESCRIPTION (provided by applicant): A large unmet need exists in medical markets for a product to assist the Emergency Department physician in the rapid triage of high-risk cardiac-patients. A new cutting-edge device is proposed to reduce physician error as well as hospital costs. The Phase-1 aim is to develop user-friendly analytic software to be used on conventional digital ECG's to predict risk of arrhythmic death. The proposal is supported by results from two independent prospective studies which show that the analysis of heart rate variability (HRV) by the Company's proprietary algorithm is highly predictive of arrhythmic death in ER patients and of all cause mortality in survivors of myocardial infarction. ECG analysis by this proprietary algorithm currently requires experts in signal analysis. The goal of this proposal is to develop software meeting FDA specifications that can be used by actual hospital personnel in an actual clinical situation. The two Specific Aims of this fast-track proposal are 1) the creation of user-friendly software for use by hospital personnel, and 2) the testing and establishment of "good medical practice" through wide experimental use of this software at different Emergency Room sites. Both aims are pivotal for commercialization.