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NCT06870591Recruiting

Pivotal Study for the Cardiac Performance System (CPS)

Sensydia Corporation

Start Date

4/22/2025

Completion Date

5/30/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

DEVICE

Cardiac Performance System (CPS)

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Conditions

Cardiovascular Diseases

Locations

Huntsville Hospital Heart Center

Huntsville, Alabama 35801

United States

Endeavor Health

Evanston, Illinois 60201

United States

Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Jersey Shore University Medical Center

Neptune City, New Jersey 07753

United States

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, New York 10032

United States

The Ohio State University Medical Center

Columbus, Ohio 43210

United States

University of Pennsylvania - Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

The Stern Cardiovascular Foundation, Inc. / Baptist Memorial Hospital

Germantown, Tennessee 38138

United States

Baylor College of Medicine

Houston, Texas 77030

United States