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

NCT07155434 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2026-03-09

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • UltraSight

    lead INDUSTRY

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2026-02-24
Completion
2026-02-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07155434 on ClinicalTrials.gov