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The purpose of this clinical trial is to demonstrate that cardiac output (CO) as determined with the Clinical Platform (Model:EV1000A, Software Version:1.9) in a noninvasive manner is comparable to CO as determined by Pulmonary Artery Catheter (PAC) thermodilution (TD). The results of this study may be used for registration and regulatory submissions.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System | Device | EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output using the Non-invasive ClearSight System | Cardiac Output using the Non-invasive ClearSight System | Expected to last no more than 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage error (PE) between the ClearSight System CO and TD | The percentage error (PE) between the ClearSight System CO and TD | Expected to last no more than 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective major cardiothoracic surgery with an indwelling PA catheter. The surgical intervention includes, but is not limited to, mitral valve surgery or coronary artery bypass grafting.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Cardiovascular Disease Hospital, Chinese Academy of Medical Sciences, Beijing | Xicheng | Beijing Municipality | 100037 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35676705 | Derived | Wang Y, Huang W, Han J, Tian Y, Wang C, Li L. A comparison of ClearSight noninvasive cardiac output and pulmonary artery bolus thermodilution cardiac output in cardiac surgery patients. Perioper Med (Lond). 2022 Jun 9;11(1):24. doi: 10.1186/s13741-022-00248-1. |
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| Wuhan Asia Heart Hospital |
| Wuhan |
| Hubei |
| 430072 |
| China |
| Tianjin Chest Hospital | Xiaobailou | Tianjin Municipality | 300300 | China |