Pivotal Study for the Cardiac Performance System (CPS)

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huntsville Hospital Heart Center, Huntsville, Alabama, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Performance System (CPS)

Device

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

Primary outcomes

Cardiac Performance System electronic data for Pulmonary Pressure

Time frame: 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

Time frame: During right heart catheterization procedure

Cardiac function metric measurement including Pulmonary Pressure measured in mmHg

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Sensydia Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 11, 2025
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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