Development of an Algorithm to Differentiate Heart Murmurs Using Electronic Stethoscopes

NCT04400513 | Completed

• 1 other identifier: 2020.3
• Study Type: observational
• Target: 1,145
• Locations: 1 country
• Sites: 1

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.

Conditions

Murmur, Heart; Aortic Valve Stenosis; Tricuspid Regurgitation; Mitral Regurgitation; Innocent Murmurs; Heart Murmurs

Keywords

artificial intelligence; machine learning

Outcome Measures

Primary Outcomes (1)

• Murmur Timing

  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.

  Within two minutes of device use

Secondary Outcomes (2)

• Systolic Murmur Type Classification

  Within two minutes of device use

• Systolic Murmur Severity Classification

  Within two minutes of device use

Study Arms (6)

Aortic Stenosis

Subjects with echo-confirmed AS graded moderate-to-severe or worse

Device: Use of Eko CORE and Eko DUO 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

Tricuspid Regurgitation

Subjects with echo-confirmed TR graded moderate-to-severe or worse

Device: Use of Eko CORE and Eko DUO electronic stethoscopes

Innocent Murmur

Subjects with echo-confirmed trace/trivial valve disease severity

Device: Use of Eko CORE and Eko DUO 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

Continuous Murmur

Subjects with pathology associated with continuous murmur (e.g. congenital shunts, PDA)

Device: Use of Eko CORE and Eko DUO electronic stethoscopes

Interventions

Use of Eko CORE and Eko DUO electronic stethoscopes DEVICE

Auscultation of heart sounds using electronic stethoscopes

Aortic Stenosis; Continuous Murmur; Diastolic Murmur; Innocent Murmur; Mitral Regurgitation; Tricuspid Regurgitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (1)

CoxHealth

Springfield, Missouri, 65807, United States

Location

MeSH Terms

Conditions

Heart Murmurs; Aortic Valve Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 22, 2020
• Study Start: June 25, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (1)