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Clinical Validation of Portable Electronic Stethoscope for Detecting VHD

Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07568795
Enrollment
125
Registered
2026-05-06
Start date
2024-07-03
Completion date
2026-12-31
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Diseases

Brief summary

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

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.

Interventions

DEVICEBPM Core

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of valvular heart disease diagnosis using portable electronic stethoscope and machine learning-based diagnostic algorithms.from admission to discharge, up to 1 hourComparison between the algorithm diagnosis to those made by the clinicians using the collected heart auscultation data and echocardiogram results

Countries

Hong Kong

Contacts

CONTACTChun Ka Wong, Clinical Assistant Professor
wongeck@hku.hk852 2255 3597

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026