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RECRUITING
NCT07215715

US Benchmarking Clinical Study

Sponsor: eMyosound SAS

View on ClinicalTrials.gov

Summary

The goal of this observational study is to measure shear wave velocity (SWV) in patients with non-reduced left ventricular ejection fraction (LVEF) heart failure and left ventricular hypertrophy, with or without transthyretin amyloidosis with cardiomyopathy (ATTR-CM), and in control subjects without heart failure or cardiomyopathy. The main question it aims to answer is: • Can SWV be used to measure myocardial and liver stiffness in the study's target populations? Researchers will compare patients with ATTR-CM, patients without ATTR-CM, and a control group to determine the distributions of SWV in each population. Participants will: * Have a standard cardiology assessment, including a physical exam, blood work, and an echocardiogram. * Undergo an investigational assessment with the eMyosound LYRA device to measure SWV in their myocardium and liver. * Have the investigational assessment repeated by a second observer to assess measurement reliability.

Official title: Myocardial & Hepatic Shear Wave Velocity Measurements in Patients With Non-Reduced-Ejection Fraction Heart Failure and Control Subjects - US Benchmarking Clinical Study

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

OBSERVATIONAL

Enrollment

150

Start Date

2025-09-16

Completion Date

2026-07

Last Updated

2025-10-20

Healthy Volunteers

Yes

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States