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NCT07155434 · ClinicalTrials.gov registry record
ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access
A clinical trial, sponsored by UltraSight.
- Terminated
- Registry status
- 36
- Enrollment target
NCT07155434: Clinical Trial study, sponsored by UltraSight.
NCT07155434 is a clinical trial that was terminated before completion, run by UltraSight. The registered enrollment target is 36 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07155434 was terminated before completion, sponsored by UltraSight.
- TERMINATED
- Registry status
- 36 participants
- Enrollment target
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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-07-25 |
| Est. Completion | 2026-02-24 |
Why NCT07155434 stopped before completion
NCT07155434 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 36 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07155434 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07155434 about?
NCT07155434 is a clinical study titled "ENABLE-HCM - AI-ENabled Echocardiography With Ultrasound Beyond the Echo Lab for Better HCM Imaging and Expanded Access". 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...
What is the current status of trial NCT07155434?
This trial is currently terminated. The enrollment target is 36 participants. The study started on 2025-07-25. Estimated completion is 2026-02-24.
Who is sponsoring clinical trial NCT07155434?
This trial is sponsored by UltraSight, which has 4 total clinical trials registered on ClinicalTrials.gov.
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