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Pivotal Study for the Cardiac Performance System (CPS)

RECRUITINGSponsored by Sensydia Corporation
Actively Recruiting
SponsorSensydia Corporation
Started2025-04-22
Est. completion2026-01-31
Eligibility
Age18 Years+
Locations10 sites

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

Age: 18 Years+
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

Conditions2

Cardiovascular DiseasesHeart Disease

Locations10 sites

Huntsville Hospital Heart Center
Huntsville, Alabama, 35801
Principal Investigator256-519-8472csullivan@theheartcenter.md
Endeavor Health
Evanston, Illinois, 60201
Principal Investigator847-570-2250clinicaltrials@northshore.org
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Principal Investigator551-996-2255ora@hmhn.org
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Principal Investigator551-996-2255ora@hmhn.org
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, New York, 10032
Principal Investigator212-305-5064ctoinformation@columbia.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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