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Pivotal Study for the Cardiac Performance System (CPS)

Pivotal Study for the Cardiac Performance System (CPS)

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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

Study details
    Cardiovascular Diseases

NCT06870591

Sensydia Corporation

15 October 2025

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