Pivotal Study for the Cardiac Performance System (CPS)

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06870591

Enrollment

1000

Registered

2025-03-11

Start date

2025-04-22

Completion date

2026-05-30

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Cardiac Performance System, CPS, Hemodynamic Parameters, Right Heart Catheterization

Brief 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.

Interventions

DEVICECardiac Performance System (CPS)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

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

Design outcomes

Primary

Measure	Time frame	Description
Cardiac Performance System electronic data for Pulmonary Pressure	Single measurement prior to right heart catheterization	Cardiac function metric measurement including Pulmonary Pressure measured in mmHg
Pulmonary artery catheter electronic data for Pulmonary Pressure	During right heart catheterization procedure	Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026