Pivotal Study for the Cardiac Performance System (CPS)

Last updated: May 6, 2025
Sponsor: Sensydia Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Cardiac Performance System (CPS)

Clinical Study ID

NCT06870591
CPS_PIVOTAL
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adults aged 18 years or older

  • Scheduled for clinically indicated right heart catheterization

  • Ability to provide informed consent

Exclusion

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 thatinterfere with CPS measurements

  • Measurement concerns related to data reliability or quality

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Cardiac Performance System (CPS)
Phase:
Study Start date:
April 22, 2025
Estimated Completion Date:
September 30, 2026

Study 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.

Connect with a study center

  • Huntsville Hospital Heart Center

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

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