Pivotal Study for the Cardiac Performance System (CPS)
Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
Sensydia Corporation
1,000 participants
Apr 22, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- Adults aged 18 years or older
- Scheduled for clinically indicated right heart catheterization
- Ability to provide informed consent
Exclusion Criteria4
- 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
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Interventions
CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06870591