NCT05104307

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: Stephen Esper · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Detailed description

This validation study will help to establish feasibility of using the CPS monitor to screen patients for ejection fraction (EF), CO, PASP and wedge pressure compared to a standard echocardiogram. No clinical decisions will be made as a result of the CPS device EF value and this measurement will be taken for comparison purposes only.

Conditions

• Heart Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-09
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2021-11-02
• Last updated: 2024-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study