Cardiac Performance System Data Collection Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiac Disease
- Sponsor
- Sensydia Corporation
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Cardiac Performance System electronic data for Pulmonary Artery Pressure
- 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 Pulmonary Artery Pressure
Time Frame: 10 minutes before cardiac catheterization 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 cardiac catheterization procedure
Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.
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 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.
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.