Clinical Validation of Portable Electronic Stethoscope for Detecting VHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BPM Core.
- Who it may be relevant to
- Registry conditions: Heart Valve Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Validation of Portable Electronic Stethoscope for Detecting Valvular Heart Disease
Overview
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
- Device BPM Core
Heart auscultation data will be collected from the patients in 5 different groups using BPM Core
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT07568795 · PESVAH