ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imagi… (NCT07155434) | Clinical Trial Compass
TerminatedNot Applicable
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
Stopped: The sponsor terminated the study following an internal review of program priorities.
United States36 participantsStarted 2025-07-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Emergency (non-elective) admission within 24 hours prior to participating in the study.
. Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement in Left Ventricular Ejection Fraction (LVEF)
. 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 experiencing a known or suspected acute cardiac event.
. Subjects with severe chest wall deformities as per previous medical records and physical examination.
. Subjects who have undergone pneumonectomy.
. 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.).