Pivotal Study for the Cardiac Performance System (CPS)

Sensydia Corporation1,000 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Cardiovascular Diseases

Interventions

Cardiac Performance System (CPS)DEVICE

CPS is a non-invasive platform for hemodynamic assessment that uses acoustic sensors and electrocardiogram electrodes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Huntsville Hospital Heart Center

Huntsville, Alabama, United States

RECRUITING

Endeavor Health

Evanston, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Cardiac Performance System electronic data for Pulmonary Pressure

Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Time frame: Single measurement prior to right heart catheterization

Pulmonary artery catheter electronic data for Pulmonary Pressure

Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Time frame: During right heart catheterization procedure

Data from ClinicalTrials.gov

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