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Cardiac Performance System Data Collection Study

Cardiac Performance System Data Collection Study

  • Clinical Trial Information

    Trial Contact: Longstreet, Jamie H; Hernandez-Pagan, Gloryvee; Ngo, George M.

  • IRB No: 23.048.03

    Protocol Abbrev: CPS Study

    Principal Investigator: Yahaira Ortiz Gonzalez, MD

    Age Group: Adult

    Treatment: Measurements of cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure from the Cardiac Performance System (CPS) will be compared to those from cardiac catheterization. CPS measurements will take place adjacent to the catheterization lab before entering the lab while the patient is being prepared. This is a relatively low-impact study requiring only a minimal amount of additional time.

    ClinicalTrials.gov ID: NCT04131725

  • Objective

    To evaluate the performance of a new non-invasive device for monitoring cardiac function (called the Cardiac Performance System, based on a previous iteration called the “Integrated CardioRespiratory System”
    FDA 510(k) K173156).

  • Key Eligibility

    Inclusion Criteria
    •   Ability to provide written informed consent
    •   22 years of age or older
    •   Referred for cardiac catheterization for reasons including heart failure,
    evaluation before transplant, pulmonary hypertension, shortness of breath,
    valvular disease, etc.
    Exclusion Criteria
    •   Previous Heart Transplant
    •   Presence of Left Ventricular Assist Device
    •   Surgical scars/wounds/bandages/ports at the site of sensor placement