Clinical Validation of Portable Electronic Stethoscope for Detecting VHD

NCT07568795 | Recruiting

• 1 other identifier: PESVAH
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (5)

Aortic stenosis

Device: BPM Core

Mitral stenosis

Device: BPM Core

Mitral regurgitation

Device: BPM Core

Tricuspid regurgitation

Device: BPM Core

Control

Device: BPM Core

Interventions

BPM Core DEVICE

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

Aortic stenosis; Control; Mitral regurgitation; Mitral stenosis; Tricuspid regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Mechanical heart valve
• Adult congenital heart disease

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Pok Fu Lam Rd., Hong Kong

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Chun Ka Wong, Clinical Assistant Professor

CONTACT

852 2255 3597; wongeck@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 6, 2026
• Study Start: July 3, 2024
• Primary Completion: August 21, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-12

Locations

HK (1)