Cardiac Disease
Conditions
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)
Interventions
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.
Sponsors
Sensydia Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactSensydia
Outcome results
None listed