Cardiac Disease
Conditions
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
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)
Interventions
Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.
Sponsors
University of Pittsburgh Medical Center
Sensydia Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults of age 18 or older
Exclusion criteria
* Subjects with wounds or surgical incisions at the site of sensor placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Performance System electronic data for Cardiac Output | 60 minutes during Pulmonary Artery Catheter 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 Pulmonary Artery Catheter 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 Pulmonary Artery Catheter procedure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg. |
| Pulmonary Artery Catheter electronic data for Cardiac Output | 60 minutes during Pulmonary Artery Catheter procedure | Cardiac function metric measurement including Cardiac Output to report in L/m. |
| Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure | 60 minutes during Pulmonary Artery Catheter procedure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. |
| Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure | 60 minutes during Pulmonary Artery Catheter procedure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg. |
| Echocardiography electronic data for Ejection Fraction | 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure | Cardiac function measurement including left ventricle ejection fraction to report in percentage. |
Countries
United States
Outcome results
None listed