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Recruiting NCT06870591

Pivotal Study for the Cardiac Performance System (CPS)

Conditions: Cardiovascular Diseases

Sponsor: Sensydia Corporation

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
Cardiac Performance System (CPS)
DEVICE
Locations 10
United States (10)
Medical University of South Carolina
Charleston , South Carolina
Principal Investigator
The Ohio State University Medical Center
Columbus , Ohio
Endeavor Health
Evanston , Illinois
The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital
Germantown , Tennessee
Hackensack University Medical Center
Hackensack , New Jersey
Principal Investigator
Baylor College of Medicine
Houston , Texas
Huntsville Hospital Heart Center
Huntsville , Alabama
Jersey Shore University Medical Center
Neptune City , New Jersey
Principal Investigator
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York , New York
University of Pennsylvania - Penn Presbyterian Medical Center
Philadelphia , Pennsylvania
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
22.04.2025
Completion date
30.05.2026
Registry ID
NCT06870591
Source
clinicaltrials.gov
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