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

NCT07155434 | Terminated

• 1 other identifier: ULTRA-HCM-100
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Agreement in Left Ventricular Ejection Fraction (LVEF)

  To demonstrate agreement in echocardiography data between limited transthoracic echocardiography (LTTE) exams performed by non-sonographer healthcare professionals (HCPs) using the UltraSight Software and exams performed by trained sonographers. LVEF will be assessed using Simpson's Method and categorized into predefined groups. The expert cardiologists evaluating the LVEF will be blinded to the exam performer's identity.

  1 day

Secondary Outcomes (2)

• Agreement in Quality level of Specific Echocardiographic Views Between Non-Sonographer HCPs and Sonographers, using ACEP echocardiography images' quality scale

  1 day

• Number of participants with adverse events (AEs) as assessed by CTCAE v4.0

  1 day

Other Outcomes (1)

• Agreement in Left Ventricular Outflow Tract (LVOT) Gradient Categories Between Non-Sonographer HCPs and Sonographers

  1 day

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hypertrophic obstructive cardiomyopathy (HOCM) patients eligible for mavacamten (Camzyos™) treatment

You may qualify if:

• 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.

You may not qualify if:

• Emergency (non-elective) admission within 24 hours prior to participating in the study.
• Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
• Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
• Subjects with body mass index (BMI) above 40 kg/m2.
• Subjects experiencing a known or suspected acute cardiac event.
• Subjects with severe chest wall deformities as per previous medical records and physical examination.
• Subjects who have undergone pneumonectomy.
• 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.).

Sponsors & Collaborators

• UltraSight: lead

Study Sites (1)

Cleveland Clinic, Cardiovascular Medicine Department

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Milind Desai, MD.

  Cleveland Clinic, Cardiovascular Medicine Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: September 4, 2025
• Study Start: July 25, 2025
• Primary Completion: February 24, 2026
• Study Completion: February 24, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)