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

NCT07202104 | Withdrawn FDA Device

• 1 other identifier: 2025.1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

structural heart disease; structural murmur

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  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 review by an expert panel of cardiologists.

  6 months

Interventions

Eko digital stethoscopes DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential research subjects will be screened for eligibility from cardiology clinics, echocardiogram clinics, and inpatient areas. In order to be eligible, a patient must be 18+ years of age, have a documented history of structural heart disease, and has undergone an echocardiogram within the last 30 days. If a patient meets all of the specified inclusion criteria, and none of the specified exclusion criteria, the patient or their proxy will be approached to discuss participation in the study.

You may qualify if:

• + years old
• Patient or patient's legal healthcare proxy consents to participation
• Documented history of SHD
• Undergoing (or has undergone, within 30 days) a complete echocardiogram
• Willing to have heart recordings done with two different electronic stethoscopes

You may not qualify if:

• Patient or proxy is unwilling/unable to give written informed consent
• Unable to complete a complete echocardiogram, or none recent completed within the last 30 days
• No documented history of SHD
• Experiencing a known or suspected acute cardiac event
• Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000)
• Unwilling or unable to follow or complete study procedures

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

Cox Medical Centers

Springfield, Missouri, 65807, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: June 29, 2026
• Primary Completion: June 29, 2026
• Study Completion: June 29, 2026
• Last Updated: July 15, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)