Trials / Terminated
TerminatedNCT07155434
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
Evaluation of Limited Trans Thoracic Echocardiography (L-TTE) by Non-Sonographers Using the UltraSight AI Guidance Software in Hypertrophic Obstructive Cardiomyopathy (HOCM) Patients Eligible for Mavacamten (Camzyos™) Treatment
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 36 (actual)
- Sponsor
- UltraSight · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is evaluating whether healthcare providers without specialized ultrasound training can use UltraSight's Guidance Software to perform heart ultrasound exams (limited transthoracic echocardiography) in patients with hypertrophic obstructive cardiomyopathy (HOCM) who are receiving or eligible for treatment with Camzyos™ (mavacamten). The study aims to determine if the software-guided images are comparable to those taken by the sonographers, in quality. Participants will receive two echocardiography scans on the same day (one by a non-sonographer using UltraSight's Guidance Software and one by a sonographer), and the image quality will be reviewed by expert cardiologists. The study aims to increase patients' access to cardiac monitoring, especially for this patient population, by enabling more healthcare professionals to perform these echocardiography exams safely and effectively.
Conditions
- Hypertrophic Cardiomyopathy (HCM)
- Cardiac Imaging
- Echocardiography
- Mavacamten
- Obstructive Cardiomyopathy, Hypertrophic
Timeline
- Start date
- 2025-07-25
- Primary completion
- 2026-02-24
- Completion
- 2026-02-24
- First posted
- 2025-09-04
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07155434. Inclusion in this directory is not an endorsement.