Cardiac Performance System Data Collection Study
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Cardiac Performance System (NSR)
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.
|
Outcome Measures
Primary Outcome Measures
- Cardiac Performance System electronic data for Cardiac Output [10 minutes before cardiac catheterization procedure]
Cardiac function metric measurement including Cardiac Output to report in L/m.
- Cardiac Performance System electronic data for Pulmonary Artery Pressure [10 minutes before cardiac catheterization procedure]
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
- Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure [10 minutes before cardiac catheterization procedure]
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
- Pulmonary Artery Catheter electronic data for Cardiac Output [60 minutes during cardiac catheterization procedure]
Cardiac function metric measurement including Cardiac Output to report in L/m.
- Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure [60 minutes during cardiac catheterization procedure]
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
- Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure [60 minutes during cardiac catheterization procedure]
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.
- Echocardiography electronic data for Ejection Fraction [15 minutes at a time prior to or after Pulmonary Artery Catheter procedure]
Cardiac function measurement including left ventricle ejection fraction to report in percentage.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ability to provide written informed consent
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22 years of age or older
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Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.
Exclusion Criteria:
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Previous Heart Transplant
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Presence of Left Ventricular Assist Device
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Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement
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Surgical scars/wounds/bandages/ports at the site of sensor placement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Health | Orlando | Florida | United States | 32806 |
Sponsors and Collaborators
- Sensydia Corporation
- Orlando Health, Inc.
Investigators
- Principal Investigator: Yahaira Ortiz-Gonzalez, MD, Orlando Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CPS_ORLANDO