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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-09

Study Completion Date

2024-01-02

Brief Summary

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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)

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Detailed Description

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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

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Heart Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Performance System (NSR)

Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram

Cardiac Performance System (CPS) Device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No