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

Study Overview
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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)

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.

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

Conditions
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Heart Diseases

Intervention / Treatment
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* Device: Cardiac Performance System (CPS) Device


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Performance System (NSR)<br>Subjects will wear Cardiac Performance System (CPS) non-invasive device during their standard echocardiogram | Device: Cardiac Performance System (CPS) Device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Performance System electronic data for Ejection Fraction | Cardiac function measurement including left ventricle ejection fraction to report in percentage | 60 minutes during Echocardiography procedure | 
| Cardiac Performance System electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m | 60 minutes during Echocardiography procedure | 
| Cardiac Performance System electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Echocardiography procedure | 
| Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg | 60 minutes during Echocardiography procedure | 
| Echocardiography electronic data for Ejection Fraction | Cardiac function measurement including left ventricle ejection fraction to report in percentage | 60 minutes during Echocardiography procedure | 
| Echocardiography electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m | 60 minutes during Echocardiography procedure | 
| Echocardiography electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Echocardiography procedure | 
| Echocardiography electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg | 60 minutes during Echocardiography procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular