Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study

CompletedOBSERVATIONAL
Enrollment

79

Participants

Timeline

Start Date

November 9, 2021

Primary Completion Date

January 2, 2024

Study Completion Date

January 2, 2024

Conditions
Heart Diseases
Interventions
DEVICE

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.

Trial Locations (1)

15212

UPMC Montefiore Hospital, Pittsburgh

All Listed Sponsors
collaborator

Sensydia Corporation

INDUSTRY

lead

Stephen Esper

OTHER

NCT05104307 - Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study | Biotech Hunter | Biotech Hunter