Cardiac Function Non-Invasive Monitoring System Evaluation Trial

Study Overview
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Brief Summary
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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)

Detailed Description
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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)

Official Title
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Cardiac Function Monitoring System Evaluation

Conditions
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Cardiac Disease

Intervention / Treatment
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* Device: Cardiac Performance System (NSR)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults of age 18 or older Exclusion Criteria: Subjects with wounds or surgical incisions at the site of sensor placement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Function Monitoring<br>Subjects will wear Cardiac Performance System (CPS) non-invasive device for brief periods during procedures including assessment by Pulmonary Artery Catheter (PAC) methods. | Device: Cardiac Performance System (NSR)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |