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Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04400513
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Eko Devices, Inc.

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 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.

Condition or disease Intervention/treatment
Murmur, Heart Aortic Valve Stenosis Tricuspid Regurgitation Mitral Regurgitation Innocent Murmurs Heart Murmurs Device: Use of Eko CORE and Eko DUO electronic stethoscopes

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Study Type : Observational
Estimated Enrollment : 1145 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Development of an Algorithm to Differentiate Heart Murmurs by Timing, Disease Type, and Severity in Adult Patients Using Electronic Stethoscopes
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Aortic Stenosis
Subjects with echo-confirmed AS graded moderate-to-severe or worse
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes

Mitral Regurgitation
Subjects with echo-confirmed MR graded moderate-to-severe or worse
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes

Tricuspid Regurgitation
Subjects with echo-confirmed TR graded moderate-to-severe or worse
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes

Innocent Murmur
Subjects with echo-confirmed trace/trivial valve disease severity
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes

Diastolic Murmur
Subjects with pathology associated with diastolic murmur (e.g. AR, PR, MS, TS)
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes

Continuous Murmur
Subjects with pathology associated with continuous murmur (e.g. congenital shunts, PDA)
Device: Use of Eko CORE and Eko DUO electronic stethoscopes
Auscultation of heart sounds using electronic stethoscopes




Primary Outcome Measures :
  1. Murmur Timing [ Time Frame: Within two minutes of device use ]
    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.


Secondary Outcome Measures :
  1. Systolic Murmur Type Classification [ Time Frame: Within two minutes of device use ]
    Develop a model that can classify systolic murmurs into disease categories including aortic stenosis (AS), mitral regurgitation (MR), tricuspid regurgitation (TR), other (O), and innocent murmurs (I).

  2. Systolic Murmur Severity Classification [ Time Frame: Within two minutes of device use ]
    Develop a model that can grade the severity of AS, MR, and TR following the American Society of Echocardiography (ASE) guidelines as mild, moderate, or severe.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be screened for eligibility from cardiology clinics, echocardiogram clinics, and inpatient areas. Alternatively, potential subjects will be identified in the echocardiography clinic the day of their echocardiogram appointment and approached for participation once eligibility is confirmed.
Criteria

Inclusion Criteria:

  1. Adults aged 18 years and older
  2. Patient or patient's legal healthcare proxy consents to participation
  3. Have an audible heart murmur in at least one auscultation position, as heard by a clinician
  4. Undergoing or have undergone a complete (i.e., not limited) echocardiogram
  5. Willing to have heart recordings done with two different electronic stethoscopes

Exclusion Criteria:

  1. Patient or proxy is unwilling or unable to give written informed consent
  2. Unable to complete a full clinical echocardiogram
  3. No audible heart murmur in at least one auscultation position, as heard by a clinician
  4. Experiencing a known or suspected acute cardiac event
  5. Mechanical ventricular support (such as ECMO, LVAD, RVAD, BiVAD, Impella, intra-aortic balloon pumps, TAH, VentrAssist, DuraHeart, HVAD, EVAHEART LVAS, HeartMate, Jarvik 2000)
  6. Unwilling or unable to follow or complete study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400513


Locations
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United States, Missouri
CoxHealth Recruiting
Springfield, Missouri, United States, 65807
Contact: Amy Weatherfield    417-269-0599    amy.weatherfield@coxhealth.com   
Sponsors and Collaborators
Eko Devices, Inc.
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Responsible Party: Eko Devices, Inc.
ClinicalTrials.gov Identifier: NCT04400513    
Other Study ID Numbers: 2020.3
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eko Devices, Inc.:
artificial intelligence
machine learning
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Aortic Valve Stenosis
Tricuspid Valve Insufficiency
Heart Murmurs
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction