NCT07202104

Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: Eko Devices, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate a machine learning model's ability to detect murmurs indicative of structural heart disease ("structural murmur") by analyzing phonocardiogram waveforms-and simultaneous electrocardiogram waveforms when available-in multiple auscultatory positions per subject. Diagnosis of structural murmur will be confirmed by gold-standard echocardiography and reviewed by an expert panel of cardiologists.

Conditions

• Structural Heart Disease

Interventions

Type	Name	Description
DEVICE	Eko digital stethoscopes	Use of the Eko CORE 500 digital stethoscope and 3M Littmann CORE Digital Stethoscope to auscultate and record cardiac phonocardiogram and (when available) electrocardiogram waveforms, as well as heart sounds.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2025-10-01
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study