Cardiac Function Monitoring System Evaluation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Disease
- Sponsor
- Sensydia Corporation
- Enrollment
- 275
- Locations
- 1
- Primary Endpoint
- Pulmonary Artery Catheter electronic data for Cardiac Output
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults of age 18 or older
Exclusion Criteria
- •Subjects with wounds or surgical incisions at the site of sensor placement
Outcomes
Primary Outcomes
Pulmonary Artery Catheter electronic data for Cardiac Output
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Wedge Pressure
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.
Cardiac Performance System electronic data for Cardiac Output
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Cardiac Output to report in L/m.
Cardiac Performance System electronic data for Pulmonary Artery Pressure
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
Cardiac Performance System electronic data for Pulmonary Artery Wedge Pressure
Time Frame: 60 minutes during Pulmonary Artery Catheter procedure
Cardiac function metric measurement including Pulmonary Artery Wedge Pressure to report in mmHg.
Echocardiography electronic data for Ejection Fraction
Time Frame: 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.