Heart Diseases
Conditions
Keywords
cardiovascular
Brief 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.
Interventions
DEVICECardiac 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
Sensydia Corporation
Stephen Esper
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Performance System electronic data for Ejection Fraction | 60 minutes during Echocardiography procedure | Cardiac function measurement including left ventricle ejection fraction to report in percentage |
| Cardiac Performance System electronic data for Cardiac Output | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Cardiac Output to report in L/m |
| Cardiac Performance System electronic data for Pulmonary Artery Pressure | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. |
| Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg |
| Echocardiography electronic data for Ejection Fraction | 60 minutes during Echocardiography procedure | Cardiac function measurement including left ventricle ejection fraction to report in percentage |
| Echocardiography electronic data for Cardiac Output | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Cardiac Output to report in L/m |
| Echocardiography electronic data for Pulmonary Artery Pressure | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. |
| Echocardiography electronic data for Pulmonary Artery Wedge Pressure | 60 minutes during Echocardiography procedure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg |
Countries
United States
Outcome results
None listed