Pivotal Study for the Cardiac Performance System (CPS)

Launched by SENSYDIA CORPORATION · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Pivotal Study for the Cardiac Performance System (CPS), is looking at a new device that can measure important heart-related information without needing any invasive procedures. The goal is to see how well this non-invasive device compares to traditional methods used during a procedure called right heart catheterization, which is typically done to gather data about heart function. By comparing the two methods, researchers hope to determine if the CPS can provide accurate and useful measurements for patients with cardiovascular diseases.

To participate in this study, you need to be at least 18 years old and scheduled for a right heart catheterization. You should also be able to understand the study and give your consent to participate. However, people who have had a heart transplant, have a device to assist heart function, or have certain external devices that might interfere with the CPS measurements won't be eligible. If you join the study, you can expect to have your heart measurements taken with both the CPS and the standard method, helping researchers learn more about the value of this new technology for patient care.

Gender

ALL

Eligibility criteria

• 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