Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements

Transthoracic echocardiography is an essential imaging modality for the diagnosis and follow-up of cardiovascular diseases. Comprehensive echocardiographic assessment requires multiple quantitative measurements of cardiac structure and function, which are time-consuming and highly dependent on operator expertise. US2.AI (Us2.v1) is an artificial intelligence (deep learning)-based software designed to automatically analyze standard two-dimensional and Doppler echocardiographic DICOM video clips acquired from different ultrasound vendors. The software provides automated measurements of cardiac morphology and function, including chamber dimensions and volumes, left and right ventricular systolic and diastolic function, myocardial strain, and Doppler-derived parameters, generating a comprehensive echocardiographic report based on current international guideline recommendations. In addition, the software may assist in identifying echocardiographic features suggestive of several cardiovascular conditions, including heart failure, pulmonary hypertension, hypertrophic cardiomyopathy, cardiac amyloidosis, valvular heart disease, and ischemic cardiomyopathy.

NCT Number	NCT07738419
Lead Sponsor	Centro Cardiologico Monzino Collaborators: Azienda Ospedaliero Universitaria Policlinico Modena, Universita di Verona, Monaldi Hospital, Napoli, Italy, ASST Grande Ospedale Metropolitano Niguarda, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Ospedale San Giovanni Evangelista Tivoli
Conditions	Echocardiography, Artificial Intelligence, Diagnostic Imaging
Enrollment	1,157 participants
Start Date	2026-04-27
Primary Completion	2027-01-31 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-31