79
Participants
Start Date
November 9, 2021
Primary Completion Date
January 2, 2024
Study Completion Date
January 2, 2024
Cardiac Performance System (CPS) Device
CPS is a passive measurement system that acquires signals from multiple sensor sources that monitor cardiac heart sounds. The passive sensor systems measure sound only and do not produce energy. The CPS system also includes a Patient Monitor device that acquires data from the sensors as well as from three standard ECG electrodes. The CPS system does not acquire or store any protected health information or any subject characteristics. The CPS system has received FDA clearance K173156. Note that the CPS system was previously named Integrated CardioRespiratory (ICR) system. The CPS is FDA cleared for the ejection fraction (EF) assessment which will be its intended use for this study.
UPMC Montefiore Hospital, Pittsburgh
Sensydia Corporation
INDUSTRY
Stephen Esper
OTHER