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: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic, Cardiovascular Medicine Department
RECRUITING
Cleveland
Contact Information
Primary
Noa Avisar, PhD
noa@ultrasight.com
+972-54-8886425
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2026-03
Participants
Target number of participants: 75
Treatments
Hypertrophic obstructive cardiomyopathy (HOCM) Patients Undergoing two Echo Exams
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.
Sponsors
Leads: UltraSight

This content was sourced from clinicaltrials.gov