Pivotal Study for the Cardiac Performance System (CPS)

Description

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.

Conditions

Cardiovascular Diseases

Study Overview

Study Details

Study 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.

Pivotal Method-Comparison Study for the Cardiac Performance System (CPS) to Measure Hemodynamic Parameters

Pivotal Study for the Cardiac Performance System (CPS)

Condition
Cardiovascular Diseases
Intervention / Treatment

-

Contacts and Locations

Huntsville

Huntsville Hospital Heart Center, Huntsville, Alabama, United States, 35801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults aged 18 years or older
  • * Scheduled for clinically indicated right heart catheterization
  • * Ability to provide informed consent
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sensydia Corporation,

Study Record Dates

2026-09-30