Pivotal Study for the Cardiac Performance System (CPS)

Last updated: November 25, 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: 1000
Treatment Group(s): 1
Primary Treatment: Cardiac Performance System (CPS)
Phase:
Study Start date:
April 22, 2025
Estimated Completion Date:
May 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

    Site Not Available

  • Huntsville Hospital Heart Center

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Active - Recruiting

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Endeavor Health

    Evanston 4891382, Illinois 4896861 60201
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Active - Recruiting

  • Jersey Shore University Medical Center

    Neptune City 5101687, New Jersey 5101760 07753
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • The Ohio State University Medical Center

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • University of Pennsylvania - Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • University of Pennsylvania - Penn Presbyterian Medical Center

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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