Actively Recruiting
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
Led by Eko Devices, Inc. · Updated on 2025-10-01
125
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a machine learning model designed to detect murmurs that suggest structural heart disease by analyzing heart sound waveforms recorded from multiple chest locations. This study focuses on adults with documented structural heart disease who have recently undergone or are undergoing echocardiograms, which serve as the gold standard for confirming the diagnosis. Expert cardiologists will review the diagnostic results to validate the model's accuracy. The study uses two types of digital stethoscopes, the Eko CORE 500 and 3M Littmann CORE Digital Stethoscope, to record phonocardiogram and, when available, electrocardiogram waveforms during heart sound recording sessions. Participants will have heart recordings taken with both devices to gather the necessary data. This observational study does not involve drug treatments but focuses on device-based data collection for algorithm assessment. Participants will undergo heart sound recordings at multiple auscultation points using the digital stethoscopes. Researchers will collect and analyze these recordings alongside echocardiogram results and expert cardiologist evaluations. The main outcome measure is assessed over a 6-month period, during which the machine learning algorithm's performance in detecting structural murmurs will be monitored. The total participation duration and additional follow-up details are not specified.
CONDITIONS
Brief Title
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Patient or legal healthcare proxy consents to participate
- Documented history of structural heart disease
- Undergoing or has completed a full echocardiogram within the last 30 days
- Willing to have heart recordings done with two different electronic stethoscopes
You will not qualify if you...
- Patient or proxy unwilling or unable to give written informed consent
- Unable to complete a full echocardiogram or no recent echocardiogram within 30 days
- No documented history of structural heart disease
- Experiencing a known or suspected acute cardiac event
- Has mechanical ventricular support devices such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, or Jarvik 2000
- Unwilling or unable to follow or complete study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants have heart recordings done using two different electronic stethoscopes to collect cardiac phonocardiogram and electrocardiogram waveforms.
1 to 2 visits depending on participant availability
Duration - 6 months
Participants are monitored for outcomes related to structural heart murmurs over the study period.
Follow-up assessments may occur during this time
Trial Site Locations
Total: 1 location
1
Cox Medical Centers
Springfield, Missouri, United States, 65807
Actively Recruiting
Research Team
C
Clinical Research Associate
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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