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| Name | Class |
|---|---|
| University of Pittsburgh Medical Center | OTHER |
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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)
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Function Monitoring | Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Performance System (NSR) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Performance System electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m. | 60 minutes during Pulmonary Artery Catheter procedure |
| Cardiac Performance System electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Pulmonary Artery Catheter procedure |
| Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg. | 60 minutes during Pulmonary Artery Catheter procedure |
| Pulmonary Artery Catheter electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m. | 60 minutes during Pulmonary Artery Catheter procedure |
| Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 60 minutes during Pulmonary Artery Catheter procedure |
| Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure | Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg. | 60 minutes during Pulmonary Artery Catheter procedure |
| Echocardiography electronic data for Ejection Fraction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for Pulmonary Artery Catheter procedure
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| Name | Affiliation | Role |
|---|---|---|
| William Kaiser, PhD | Sensydia Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | United States |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Cardiac function measurement including left ventricle ejection fraction to report in percentage. |
| 15 minutes at a time prior to or after Pulmonary Artery Catheter procedure |