Pivotal Study for the Cardiac Performance System (CPS)

Sensydia

Status: Enrolling

Conditions: Cardiovascular Diseases

Treatments: Device: Cardiac Performance System (CPS)

Study type: Observational

Funder types: Industry

Identifiers

NCT06870591

CPS_PIVOTAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

CPS Measurement Group

Description:

Participants undergoing clinically indicated right heart catheterization will receive a single, non-invasive measurement using the Cardiac Performance System (CPS) before their scheduled procedure. The study aims to compare CPS results with standard invasive hemodynamic measurements.

Treatment:

Device: Cardiac Performance System (CPS)