Clinical Trial

ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access

Terminated
View on ClinicalTrials.gov →
Why the trial stopped
The sponsor terminated the study following an internal review of program priorities.
Summary
This study evaluates whether healthcare providers without specialized ultrasound training can use UltraSight's machine learning based Guidance Software to perform limited transthoracic echocardiography in patients with hypertrophic obstructive cardiomyopathy (HOCM), who are receiving or eligible for mavacamten (Camzyos™). Participants will undergo two heart scans on the same day, one by a non-sonographer using the software and one by a trained sonographer. The study aims to determine if the software-guided images are comparable in quality, with the goal of expanding access to heart monitoring for HCM patients.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-26.
Status change: Recruiting → Terminated 2026-03-05
Trial Details
NCT Number NCT07155434
Lead Sponsor UltraSight
Conditions Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography, Mavacamten, Obstructive Cardiomyopathy, Hypertrophic
Enrollment 36 participants
Start Date 2025-07-25
Primary Completion 2026-02-24 (estimated)
Study Completion 2026-02-24 (estimated)
Updated on ClinicalTrials.gov 2026-03-09