AI ECHO INSIGHT RCT for Automated Echo Reporting

The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed. The main questions it aims to answer is to: 1. Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows. 2. Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow. 3. To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.

NCT Number	NCT07229300
Lead Sponsor	Kaiser Permanente
Conditions	Echocardiography, Transthoracic, Echocardiographic Software
Enrollment	1,200 participants
Start Date	2025-11-01
Primary Completion	2026-08-01 (estimated)
Study Completion	2026-08-20 (estimated)
Updated on ClinicalTrials.gov	2026-08-06