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Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
NCT04400513 · View on ClinicalTrials.gov ↗
Study Summary
The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.
Conditions Studied
Interventions
- DEVICE Use of Eko CORE and Eko DUO electronic stethoscopes
Study Locations (1)
Missouri
- CoxHealth — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,145 participants |
| Start Date | 2020-06-25 |
| Est. Completion | 2021-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04400513
The ClinicalTrials.gov registry entry for NCT04400513 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eko Devices, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 1 intervention — of which Use of Eko CORE and Eko DUO electronic stethoscopes is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04400513 reports 1 study location spanning 1 distinct geographic area — top geographies include Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04400513 about?
NCT04400513 is a clinical study titled "Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes". The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs....
What is the current status of trial NCT04400513?
This trial is currently completed. The enrollment target is 1,145 participants. The study started on 2020-06-25. Estimated completion is 2021-12-31.
What conditions does trial NCT04400513 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Mitral Regurgitation, Tricuspid Regurgitation, Heart Murmurs, Murmur, Heart. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04400513?
The interventions under investigation include: Use of Eko CORE and Eko DUO electronic stethoscopes (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04400513?
This trial is sponsored by Eko Devices, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04400513 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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