RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-25
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07155434

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female subjects aged 18 years or over at the time of screening.
  2. 2. Willing and able to give written informed consent.
  3. 3. New York Heart Association (NYHA) Class I to III
  4. 4. Eligible to receive or currently receiving CamzyosTM per product labelling.
  1. 1. Emergency (non-elective) admission within 24 hours prior to participating in the study.
  2. 2. Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
  3. 3. Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
  4. 4. Subjects with body mass index (BMI) above 40 kg/m2.
  5. 5. Subjects experiencing a known or suspected acute cardiac event.
  6. 6. Subjects with severe chest wall deformities as per previous medical records and physical examination.
  7. 7. Subjects who have undergone pneumonectomy.
  8. 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.).

Contacts and Locations

Study Contact

Noa Avisar, PhD
CONTACT
+972-54-8886425
noa@ultrasight.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: UltraSight

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-07-25
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

  • hypertrophic cardiomyopathy
  • ultrasound
  • echocardiography
  • sonographer
  • monitoring
  • Guidance
  • software
  • UltraSight
  • image quality
  • REMS

Additional Relevant MeSH Terms

  • Hypertrophic Cardiomyopathy (HCM)
  • Cardiac Imaging
  • Echocardiography
  • Mavacamten
  • Obstructive Cardiomyopathy, Hypertrophic