Evaluating a non-invasive device for measuring heart function
Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
This study tests a new non-invasive device to see if it can accurately measure heart function in adults who are already having a procedure to check their heart.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sensydia Corporation Industry-sponsored |
| Locations | 10 sites (Huntsville, Alabama and 9 other locations) |
| Trial ID | NCT06870591 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the accuracy of the Cardiac Performance System (CPS), a non-invasive device, in measuring hemodynamic parameters in adults undergoing right heart catheterization. Participants will have a CPS measurement taken prior to their scheduled procedure, and the results will be compared to invasive measurements obtained during catheterization. The goal is to evaluate the agreement between these two measurement methods and determine the potential clinical utility of the CPS. No additional treatments or follow-up visits are required for participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older who are scheduled for clinically indicated right heart catheterization.
Not a fit: Patients who have had a heart transplant, those with a left ventricular assist device, or individuals with external devices that interfere with CPS measurements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable non-invasive method for assessing heart function, potentially improving patient care in cardiovascular diseases.
How similar studies have performed: While this approach is innovative, similar studies evaluating non-invasive hemodynamic monitoring devices have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Huntsville, Alabama and 9 other locations
- Huntsville Hospital Heart Center — Huntsville, Alabama, United States (Recruiting)
- Endeavor Health — Evanston, Illinois, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- Jersey Shore University Medical Center — Neptune City, New Jersey, United States (Recruiting)
- Columbia University Irving Medical Center / NewYork-Presbyterian Hospital — New York, New York, United States (Recruiting)
- The Ohio State University Medical Center — Columbus, Ohio, United States (Recruiting)
- University of Pennsylvania - Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital — Germantown, Tennessee, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.