Evaluating a non-invasive device for measuring heart function
Official title: Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters
Run by Sensydia Corporation · NCT06870591 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Sensydia Corporation Industry-sponsored |
| Locations | 10 sites (Huntsville, Alabama and 9 other locations) |
| Status | Recruiting |
| Started | April 22, 2025 |
| Main results expected | April 30, 2026 |
| Study ends | May 30, 2026 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT06870591 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 years or older who are scheduled for clinically indicated right heart catheterization.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is innovative, similar studies evaluating non-invasive hemodynamic monitoring devices have shown promise, suggesting potential for success.
Who can join: the full rules
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 it's running
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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
Show 4 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.