Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Sensydia

Status: Completed

Conditions: Cardiac Disease

Treatments: Device: Cardiac Performance System (NSR)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04131725

CPS_002_2019

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

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)

Enrollment: 275 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults of age 18 or older

Exclusion criteria

• Subjects with wounds or surgical incisions at the site of sensor placement

Trial design

275 participants in 1 patient group

Cardiac Function Monitoring

Description:

Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods.

Treatment:

Device: Cardiac Performance System (NSR)