Cardiac Performance System Data Collection Study - Minnesota
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Disease
- Sponsor
- Sensydia Corporation
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cardiac Performance System electronic data for Cardiac Output
- Status
- Recruiting
- 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
- •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
Outcomes
Primary Outcomes
Cardiac Performance System electronic data for Cardiac Output
Time Frame: 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
Time Frame: 10 minutes before cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery 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.
Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure
Time Frame: 60 minutes during 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
Time Frame: 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
Time Frame: 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 Capillary Wedge Pressure
Time Frame: 60 minutes during cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.