Software Tested for Reading Heart Ultrasound Scans in Adults

Trial details

Who runs it

Truway Health, Inc.

Trial code

NCT07800962

Record updated

2 September 2026

Original description

This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations. Federated learning allows participating clinical sites to contribute to model development while keeping raw ultrasound images and directly identifiable patient information within each site's controlled computing environment. Encrypted model updates, rather than patient images, will be transmitted for secure aggregation.Read full original descriptionShow less

A Prospective Multicenter Clinical-Performance Study of Federated Machine Learning for Automated Interpretation of Point-of-Care Cardiac Ultrasound

This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations. Federated learning allows participating clinical sites to contribute to model development while keeping raw ultrasound images and directly identifiable patient information within each site's controlled computing environment. Encrypted model updates, rather than patient images, will be transmitted for secure aggregation.

The prospective validation cohort will include approximately 3,000 adults undergoing clinically indicated focused cardiac ultrasound. Model performance will be compared with an expert interpretation of a comprehensive transthoracic echocardiogram performed within 24 hours. The primary objective is to determine how accurately the model identifies reduced left ventricular systolic function, defined as a left ventricular ejection fraction below 40%.

During the initial validation period, the investigational software will operate in silent mode. Its results will not be displayed to treating clinicians and will not be used to diagnose participants, select treatment, or replace standard clinical interpretation.

The study will also evaluate image-quality classification, cardiac-view recognition, performance across clinical sites and ultrasound systems, model calibration, processing time, cybersecurity, privacy resilience, and performance across demographic and clinical subgroups. Long-term monitoring will assess whether model performance changes as clinical populations, ultrasound equipment, acquisition practices, and software environments evolve during the 2026-2037 study period.

Inclusion: Age 18 years or older; Undergoing a clinically indicated point-of-care cardiac ultrasound (POCUS) examination at a participating site; Reference transthoracic echocardiogram completed within 24 hours of the index POCUS examination; At least one cardiac ultrasound view attempted during the index examination; POCUS and reference echocardiography records can be linked using an authorized coded study identifier; Participant consent obtained or inclusion authorized under an Institutional Review Board-approved consent waiver, as applicable.

Exclusion: Previous inclusion of the same participant in the primary validation cohort, unless repeat examinations are authorized under a prespecified longitudinal analysis; Major cardiac procedure or substantial hemodynamic intervention occurring between the POCUS examination and reference echocardiogram, including cardiac surgery, cardioversion, cardiac arrest, or initiation of mechanical circulatory support; Reference transthoracic echocardiogram not completed within 24 hours of the index POCUS examination; Ultrasound or reference data are missing, corrupted, irretrievable, or cannot be securely linked; Declines participation when individual informed consent is required; Member of a population not authorized for enrollment under the applicable Institutional Review Board approval.

ClinicalTrials.gov NCT07800962