Hypertrophic Cardiomyopathy (HCM)NCT07155434
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
An observational study of Hypertrophic Cardiomyopathy (HCM) and Cardiac Imaging, run by UltraSight at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2025to 24 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hypertrophic obstructive cardiomyopathy (HOCM) patients eligible for mavacamten (Camzyos™) treatment
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Cardiovascular Medicine Department
Cleveland, Ohio, 44195
About this study
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
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.
Read the 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 echocardiography) in patients with hypertrophic obstructive cardiomyopathy (HOCM) who are receiving or eligible for treatment with Camzyos™ (mavacamten). The study aims to determine if the software-guided images are comparable to those taken by the sonographers, in quality. Participants will receive two echocardiography scans on the same day (one by a non-sonographer using UltraSight's Guidance Software and one by a sonographer), and the image quality will be reviewed by expert cardiologists. The study aims to increase patients' access to cardiac monitoring, especially for this patient population, by enabling more healthcare professionals to perform these echocardiography exams safely and effectively.
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography, Mavacamten, Obstructive Cardiomyopathy, Hypertrophic
- Keywords
- hypertrophic cardiomyopathy, ultrasound, echocardiography, sonographer, monitoring, Guidance, software, UltraSight, image quality, REMS
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To demonstrate agreement in the quality of specific echocardiographic views obtained by non-sonographer healthcare professionals (HCPs) using the UltraSight Software compared to those obtained by trained sonographers. Quality will be assessed by blinded expert cardiologists using the 5-point American College of Emergency Physicians [ACEP] scale), for each of the following views: Parasternal Long-Axis (PLAX), Apical 2-Chamber (Apical 2C), Apical 3-Chamber (Apical 3C), Apical 4-Chamber (Apical 4C), Apical 5-Chamber (Apical 5C).
Measured: 1 day
Number of participants with adverse events (AEs) as assessed by CTCAE v4.0
The number of AEs, SAEs, and device related AEs will be captured as well as the number of subjects who discontinue due to an AE.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start25 Jul 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Why it stopped: The sponsor terminated the study following an internal review of program priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy (HCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- UltraSight
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milind Desai, MD., Principal investigator, Cleveland Clinic, Cardiovascular Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155434
- Sponsor's protocol ID
- ULTRA-HCM-100
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2025
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share individual participant data (IPD) has not yet been finalized. While the study data will be de-identified, additional considerations such as the proprietary nature of the investigational device, regulatory strategy, and potential for future publications or secondary analyses are still being evaluated. IPD sharing may be considered after study completion and internal review.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07155434
- Acronym / sponsor ID
- ULTRA-HCM-100
- Conditions
- Hypertrophic Cardiomyopathy (HCM), Cardiac Imaging, Echocardiography, Mavacamten, Obstructive Cardiomyopathy, Hypertrophic
- Keywords
- hypertrophic cardiomyopathy, ultrasound, echocardiography, sonographer, monitoring, Guidance, software, UltraSight
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The sponsor terminated the study following an internal review of program priorities.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- UltraSightIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 echocardiography) in patients with hypertrophic obstructive cardiomyopathy (HOCM) who are receiving or eligible for treatment with Camzyos™ (mavacamten). The study aims to determine if the software-guided images are comparable to those taken by the sonographers, in quality. Participants will receive two echocardiography scans on the same day (one by a non-sonographer using UltraSight's Guidance Software and one by a sonographer), and the image quality will be reviewed by expert cardiologists. The study aims to increase patients' access to cardiac monitoring, especially for this patient population, by enabling more healthcare professionals to perform these echocardiography exams safely and effectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypertrophic obstructive cardiomyopathy (HOCM) patients eligible for mavacamten (Camzyos™) treatment
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement in Left Ventricular Ejection Fraction (LVEF)
Time frame: 1 day
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.
2 secondary outcomes
Agreement in Quality level of Specific Echocardiographic Views Between Non-Sonographer HCPs and Sonographers, using ACEP echocardiography images' quality scale
Time frame: 1 day
Number of participants with adverse events (AEs) as assessed by CTCAE v4.0
Time frame: 1 day
Results and safety
The study was stopped early (reason given: The sponsor terminated the study following an internal review of program priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided. The decision to share individual participant data (IPD) has not yet been finalized. While the study data will be de-identified, additional considerations such as the proprietary nature of the investigational device, regulatory strategy, and potential for future publications or secondary analyses are still being evaluated. IPD sharing may be considered after study completion and internal review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milind Desai, MD. principal investigator
Cleveland Clinic, Cardiovascular Medicine Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy (HCM) and Cardiac Imaging, run by UltraSight at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The sponsor terminated the study following an internal review of program priorities.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Left Ventricular Ejection Fraction (LVEF) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.