NCT07155434Terminated
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
Source: ClinicalTrials.gov · Last updated 9 Mar 2026
Reason given: The sponsor terminated the study following an internal review of program priorities.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 36 (actual)
- First submitted
- 1 Aug 2025
- Start date
- 25 Jul 2025
- Primary completion date
- 24 Feb 2026
- Lead sponsor
- UltraSight
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT07155434
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency (non-elective) admission within 24 hours prior to participating in the study.
- Subjects with severe chest wall deformities as per previous medical records and physical examination.
Other illness
- Subjects experiencing a known or suspected acute cardiac event.
- Subjects whose anatomy does not lend itself to yield diagnosable echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.).
Other
- Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
- Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
- Subjects with body mass index (BMI) above 40 kg/m2.
- Subjects who have undergone pneumonectomy.
Who the study is looking for
- Male and female subjects aged 18 years or over at the time of screening.
- Willing and able to give written informed consent.
- New York Heart Association (NYHA) Class I to III
- Eligible to receive or currently receiving CamzyosTM per product labelling.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic, Cardiovascular Medicine Department | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.