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

Stephen Esper79 enrolled

Overview

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)

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Heart Diseases

Interventions

Cardiac Performance System (CPS) DeviceDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Patients over 18 scheduled for a standard echocardiogram Exclusion Criteria: * Patients with heart transplant history * Patients with a Implanted Left Ventricular Assist Device (LVAD) * Patients who have surgical scars, wounds, or bandages at the site of sensor placement * Inadequate TTE imaging windows in left lateral position * Otherwise deemed by the investigator as medically unfit to participate * Chest deformities including, for example, pectus excavatum

Locations (1)

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States