Cardiac Performance System Data Collection Study - Minnesota

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 Performance System Data Collection Study - Minnesota

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: Ability to provide written informed consent 22 years of age or older Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc. Exclusion Criteria: Previous Heart Transplant Presence of Left Ventricular Assist Device Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement Surgical scars/wounds/bandages/ports at the site of sensor placement

Ages Eligible for Study
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Minimum Age: 22 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 scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure. | Device: Cardiac Performance System (NSR)<br>* 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.<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. | 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 | 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 |