Status:
COMPLETED
Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes
Lead Sponsor:
Eko Devices, Inc.
Conditions:
Murmur, Heart
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Brief 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 th...
Detailed Description
Valvular heart disease (VHD), a subclass of structural heart disease (SHD), is a major cause of mortality and reduced quality of life for tens of millions of patients worldwide. Detecting VHD early al...
Eligibility Criteria
Inclusion
- Adults aged 18 years and older
- Patient or patient's legal healthcare proxy consents to participation
- Have an audible heart murmur in at least one auscultation position, as heard by a clinician
- Undergoing or have undergone a complete (i.e., not limited) echocardiogram
- Willing to have heart recordings done with two different electronic stethoscopes
Exclusion
- Patient or proxy is unwilling or unable to give written informed consent
- Unable to complete a full clinical echocardiogram
- No audible heart murmur in at least one auscultation position, as heard by a clinician
- 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
Key Trial Info
Start Date :
June 25 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1145 Patients enrolled
Trial Details
Trial ID
NCT04400513
Start Date
June 25 2020
End Date
December 31 2021
Last Update
February 15 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CoxHealth
Springfield, Missouri, United States, 65807