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

UltraSight

Status: Enrolling

Conditions: Obstructive Cardiomyopathy, Hypertrophic; Mavacamten; Echocardiography; Cardiac Imaging; Hypertrophic Cardiomyopathy (HCM)

Study type: Observational

Funder types: Industry

Identifiers

NCT07155434

ULTRA-HCM-100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

75 participants in 1 patient group

Hypertrophic obstructive cardiomyopathy (HOCM) Patients Undergoing two Echo Exams

Description:

Hypertrophic obstructive cardiomyopathy (HOCM) patients who are eligible for or currently receiving Camzyos™ (mavacamten) will undergo two limited transthoracic echocardiography (LTTE) exams on the same day: one performed by a trained sonographer, and the other by a non-sonographer healthcare provider using the UltraSight Guidance Software. The study will compare the image quality and diagnostic agreement between the two sets of scans to evaluate the software's ability to support non-experts in performing cardiac ultrasound.