RECRUITING

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

Description

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.

Conditions

Hypertrophic Cardiomyopathy (HCM)Cardiac ImagingEchocardiographyMavacamtenObstructive Cardiomyopathy, Hypertrophic
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Related Conditions:

Hypertrophic Cardiomyopathy (HCM)Cardiac ImagingEchocardiographyMavacamtenObstructive Cardiomyopathy, Hypertrophic

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hypertrophic Cardiomyopathy (HCM)
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cardiovascular Medicine Department, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UltraSight,

Milind Desai, MD., PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Cardiovascular Medicine Department

Study Record Dates

2026-03