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

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.

Eligibility

Inclusion Criteria:

1. Male and female subjects aged 18 years or over at the time of screening.
2. Willing and able to give written informed consent.
3. New York Heart Association (NYHA) Class I to III
4. Eligible to receive or currently receiving CamzyosTM per product labelling.

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 hours prior to participating in the study.
2. Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
3. Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
4. Subjects with body mass index (BMI) above 40 kg/m2.
5. Subjects experiencing a known or suspected acute cardiac event.
6. Subjects with severe chest wall deformities as per previous medical records and physical examination.
7. Subjects who have undergone pneumonectomy.
8. 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.).

Conditions6

Locations1 site

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