Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07568795

Clinical Validation of Portable Electronic Stethoscope for Detecting VHD

The goal of this observational study is to evaluate accuracy of portable electronic stethoscope and machine learning-based diagnostic algorithms for detecting the disease in people with valvular heart disease and healthy controls. The main question it aims to answer is:

Is portable electronic stethoscope and machine learning-based diagnostic algorithms allow accurate detection of valvular heart disease?

Researchers will compare diagnostic algorithm's predictions with the clinicians' predictions to see if the diagnostic results are accurate.

Participants will

* take echocardiogram * take electrocardiogram using BPM Core * get the heart auscultation data measured via electronic stethoscope

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The study compares the diagnostic accuracy of machine learning-based algorithms for diagnosis, which utilise auscultation data obtained through electronic stethoscopes, with the diagnoses made by clinicians using the same data. Two portable electronic stethoscopes used will be evaluated in this study, including BPM Core (Withings, France) and BeamO (Withings, France). The study utilises data collected from 100 patients at Queen Mary Hospital who have been diagnosed with valvular heart diseases (including aortic stenosis, mitral and/or tricuspid regurgitation, and mitral stenosis) and 25 healthy individuals without heart conditions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntarily agrees to participate by proving written informed consent
  • Have echocardiography done within 5 years

Exclusion criteria

  • Mechanical heart valve
  • Adult congenital heart disease

Treatment and study plan

BPM Core

Device

Heart auscultation data will be collected from the patients in 5 different groups using BPM Core

Primary outcomes

  1. Accuracy of valvular heart disease diagnosis using portable electronic stethoscope and machine learning-based diagnostic algorithms.

    Time frame: from admission to discharge, up to 1 hour

    Comparison between the algorithm diagnosis to those made by the clinicians using the collected heart auscultation data and echocardiogram results

Study contacts

Contact information is provided by the study sponsor or research team.

Chun Ka Wong, Clinical Assistant Professor

CONTACT

[email protected]

852 2255 3597

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.