Status:
RECRUITING
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
Lead Sponsor:
UltraSight
Conditions:
Hypertrophic Cardiomyopathy (HCM)
Cardiac Imaging
Eligibility:
All Genders
18+ years
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 echocardiograph...
Detailed Description
This study is evaluating whether healthcare providers without specialized ultrasound training can use UltraSight's Guidance Software to perform heart ultrasound exams (limited transthoracic echocardio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.).
Key Trial Info
Start Date :
July 25 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07155434
Start Date
July 25 2025
End Date
March 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
Cleveland Clinic, Cardiovascular Medicine Department
Cleveland, Ohio, United States, 44195