Echocardiogram and Cardiac Performance System (CPS) Ejection Fraction Validation Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Diseases
- Sponsor
- Stephen Esper
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Cardiac Performance System electronic data for Pulmonary Artery Pressure
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Stephen Esper
Assistant Professor
University of Pittsburgh
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Echocardiography electronic data for Pulmonary Artery Pressure
Time Frame: 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
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg
Cardiac Performance System electronic data for Ejection Fraction
Time Frame: 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
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Cardiac Output to report in L/m
Echocardiography electronic data for Ejection Fraction
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function measurement including left ventricle ejection fraction to report in percentage
Echocardiography electronic data for Cardiac Output
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Cardiac Output to report in L/m
Echocardiography electronic data for Pulmonary Artery Wedge Pressure
Time Frame: 60 minutes during Echocardiography procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg