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需求，需要一种产品来帮助急诊科医生快速分诊高危心脏病患者。一种新的尖端设备被提出来减少医生的错误以及医院的费用。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图，以预测猝死的风险。两项独立前瞻性研究的结果支持了该提议，这些研究表明，通过公司专有算法进行的心率变异性（HRV）分析高度预测了急诊室患者的死亡率和心肌梗死幸存者的全因死亡率。通过这种专有算法进行ECG分析目前需要信号分析专家。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。这项快速通道建议的两个具体目标是：1） 创建用户友好的软件，供医院工作人员使用，2）测试和 通过在不同的急诊室站点广泛试验使用该软件，建立“良好的医疗实践”。这两个目标都是商业化的关键。

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.