Pivotal Study for the Cardiac Performance System (CPS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cardiac Performance System (CPS).
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
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.
Detailed 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.
Interventions
- Device Cardiac Performance System (CPS)
CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.
Primary outcome measures
- Cardiac Performance System electronic data for Pulmonary Pressure [Time frame: Single measurement prior to right heart catheterization]
- Pulmonary artery catheter electronic data for Pulmonary Pressure [Time frame: During right heart catheterization procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 10 centers
- Huntsville Hospital Heart Center — Huntsville
- Endeavor Health — Evanston
- Hackensack University Medical Center — Hackensack
- Jersey Shore University Medical Center — Neptune City
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York
- The Ohio State University Medical Center — Columbus
- University of Pennsylvania - Penn Presbyterian Medical Center — Philadelphia
- Medical University of South Carolina — Charleston
- … and 2 more centers
Identifiers
NCT: NCT06870591 · CPS_PIVOTAL