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NCT04400513 · ClinicalTrials.gov registry record
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
A clinical trial of Aortic Valve Stenosis and Mitral Regurgitation, sponsored by Eko Devices.
- Completed
- Registry status
- 1,145
- Enrollment target
- 1
- Study location
NCT04400513: Completed study of Aortic Valve Stenosis and Mitral Regurgitation, sponsored by Eko Devices.
NCT04400513 is a study of Aortic Valve Stenosis and Mitral Regurgitation that has completed, run by Eko Devices. The registered enrollment target is 1,145 participants, above the 1,005-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04400513, a study of Aortic Valve Stenosis and Mitral Regurgitation, has completed, sponsored by Eko Devices.
- COMPLETED
- Registry status
- 1,145 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Develop a model that can classify murmurs based on the timing of the murmur in the cardiac cycle, allowing the algorithm to distinguish between systolic, diastolic, and continuous murmurs using time-synchronized ECG and PCG data.
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 |
What the finished NCT04400513 record still lists
NCT04400513 is an observational study that tracks outcomes without assigning an intervention. Its 1,145 participants enrollment target places it among the larger protocols in the corpus, above the 1,005-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (14% higher).
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.
NCT04400513 reports a single indexed study location in Missouri.
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.
What interventions are being tested in trial NCT04400513?
The interventions under investigation include: Use of Eko CORE and Eko DUO electronic stethoscopes (DEVICE).
Who is sponsoring clinical trial NCT04400513?
This trial is sponsored by Eko Devices, which has 16 total clinical trials registered on ClinicalTrials.gov.
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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Where NCT04400513's enrollment target sits among peer trials
1,145 6th of 30 higher than 25 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
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