Pivotal Study for the Cardiac Performance System (CPS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-22

Study Completion Date

2026-05-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CPS Measurement Group

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.

Cardiac Performance System (CPS)

Intervention Type DEVICE

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

Interventions

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Cardiac Performance System (CPS)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No