Ireland
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Recruiting Observational

Pivotal Study for the Cardiac Performance System (CPS)

NCT06870591 · tracked via the Priya Life Science USA tracker
Sponsor
Sensydia Corporation
Phase
Observational
Started
2025-04-22
Last updated
2026-04-24

Condition(s) studied

Cardiovascular Diseases

Investigational drug(s) / intervention(s)

Cardiac Performance System (CPS)

Cardiac Performance System (CPS): CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Cardiac Performance System electronic data for Pulmonary Pressure — Single measurement prior to right heart catheterization
    Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
  • Pulmonary artery catheter electronic data for Pulmonary Pressure — During right heart catheterization procedure
    Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Trial sites (10)

FacilityCityRegionStatus
Huntsville Hospital Heart Center Huntsville Alabama Recruiting
Endeavor Health Evanston Illinois Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Jersey Shore University Medical Center Neptune City New Jersey Recruiting
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital New York New York Recruiting
The Ohio State University Medical Center Columbus Ohio Recruiting
University of Pennsylvania - Penn Presbyterian Medical Center Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital Germantown Tennessee Recruiting
Baylor College of Medicine Houston Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06870591 on ClinicalTrials.gov ↗ ← All trials in the USA