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

Stephen Esper

Status: Completed

Conditions: Heart Diseases

Treatments: Device: Cardiac Performance System (CPS) Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05104307

STUDY21050167

Details and patient eligibility

About

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)

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

79 participants in 1 patient group

Cardiac Performance System (NSR)

Description:

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

Treatment:

Device: Cardiac Performance System (CPS) Device