Study to Validate Portable Electronic Stethoscopes and AI for Detecting Heart Valve Disease in Adults

What this Trial Is About

This research aims to evaluate how accurately portable electronic stethoscopes combined with machine learning-based diagnostic algorithms can detect valvular heart disease. It compares the algorithms predictions with clinicians diagnoses to see if these new methods provide reliable results. The study includes people diagnosed with heart valve diseases and healthy individuals for comparison. Two portable electronic stethoscopes, BPM Core and BeamO, will be used to collect heart auscultation data. Participants will undergo echocardiograms and electrocardiograms, and their heart sounds will be recorded using these devices. The study involves 100 patients with valvular heart diseases and 25 healthy controls, with data collected at a single hospital. Participants will have heart scans and tests including echocardiogram, electrocardiogram, and electronic stethoscope recordings. Researchers will assess the accuracy of the diagnostic algorithms by comparing them to clinicians assessments. The main outcome measured is how well the portable stethoscope and algorithms detect valvular heart disease within about an hour. The study runs until the end of 2026.

Clinical Validation of Portable Electronic Stethoscope for Detecting VHD