Clinical Validation of Portable Electronic Stethoscope for Detecting VHD

April 28, 2026 updated by: Wong Chun Ka, The University of Hong Kong

Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chun Ka Wong, Clinical Assistant Professor
  • Phone Number: 852 2255 3597
  • Email: wongeck@hku.hk

Study Locations

  • Hong Kong
    • Pok Fu Lam Rd.
      • Hong Kong, Pok Fu Lam Rd., Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

25 with aortic stenosis, 25 with mitral stenosis, 25 with mitral regurgitation, 25 with tricuspid regurgitation, and 25 without valvular heart disease

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Device: BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core
Aortic stenosis
Device: BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core
Mitral stenosis
Device: BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core
Mitral regurgitation
Device: BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core
Tricuspid regurgitation
Device: BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from admission to discharge, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

August 21, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PESVAH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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