Pivotal Study for the Cardiac Performance System (CPS)

Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters

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.

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.

Inclusion Criteria:

• Adults aged 18 years or older
• Scheduled for clinically indicated right heart catheterization
• Ability to provide informed consent

Exclusion Criteria:

• Heart transplant recipients
• Patients with a left ventricular assist device (LVAD)
• Presence of external devices (e.g., Holter monitors) or surgical scars/wounds that interfere with CPS measurements
• Measurement concerns related to data reliability or quality