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

NCT05104307 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2024-05-06

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Sensydia Corporation

    collaborator INDUSTRY

  • Stephen Esper

    lead OTHER

Principal Investigators

  • Stephen L Esper, MD, MBA · University of Pittsburgh Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-09
Primary Completion
2024-01-02
Completion
2024-01-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05104307 on ClinicalTrials.gov