Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
Sensydia Corporation
Summary
This multi-center, observational study evaluates the accuracy of the Cardiac Performance System (CPS), a non-invasive device, for measuring hemodynamic parameters in adult patients undergoing clinically indicated right heart catheterization. The study compares CPS measurements to invasive measurements to assess agreement and potential clinical utility.
Description
The study will enroll adults undergoing right heart catheterization as part of their clinical care. A single CPS measurement will be performed before the scheduled procedure. Data from both CPS and catheterization measurements will be analyzed to assess agreement. No investigational treatment or additional follow-up visits are required.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers