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| Name | Class |
|---|---|
| Orlando Health, Inc. | 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 scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Performance System (NSR) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Performance System electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m. | 10 minutes before cardiac catheterization procedure |
| Cardiac Performance System electronic data for Pulmonary Artery Pressure | Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg. | 10 minutes before cardiac catheterization procedure |
| Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure | Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg. | 10 minutes before cardiac catheterization procedure |
| Pulmonary Artery Catheter electronic data for Cardiac Output | Cardiac function metric measurement including Cardiac Output to report in L/m. | 60 minutes during cardiac catheterization 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 cardiac catheterization procedure |
| Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure | Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg. | 60 minutes during cardiac catheterization procedure |
| Echocardiography electronic data for Ejection Fraction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for cardiac catheterization procedure
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sensydia | Contact | 6618774670 | info@sensydia.com |
| Name | Affiliation | Role |
|---|---|---|
| Yahaira Ortiz-Gonzalez, MD | Orlando Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Health | Recruiting | Orlando | Florida | 32806 | 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 |