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eMurmur ID - Clinical Performance Evaluation

NCT03227848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2018-07-18

No results posted yet for this study

Summary

The differentiation between innocent and pathologic murmurs through traditional auscultation can often be challenging, which in the end makes the diagnosis strongly dependent on the clinitians experience and clinical expertise. With the development of technology it is now possible to help diagnose heart murmurs using computer aided auscultation systems (CAA). eMurmur ID is an investigational CAA system (not FDA cleared) and the investigators hypothesize that it can distinguish between AHA class I (pathologic murmurs) and AHA class III heart sounds (innocent murmurs and/or no murmurs) with a sensitivity and specificity not worse compared to a similar FDA cleared CAA system on market.

Conditions

  • Heart Murmurs
  • Pathologic Murmurs
  • Innocent Murmurs
  • Congenital Heart Defect
  • Systolic Murmurs
  • Diastolic Murmurs

Interventions

DEVICE

Automated Heart Murmur Detection AI

Automated AI algorithm-based analysis of digital heart sound recordings to detect and classify heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. AI algorithm results for each recording include: AHA classification (Class I (pathologic heart murmur) versus class III (innocent heart murmur or no heart murmur), murmur timing, murmur grade, heart rate and S1/S2 identification.

Sponsors & Collaborators

  • CSD Labs GmbH

    lead OTHER

Principal Investigators

  • Lillian Lai, MD · Children's Hopsital of Eastern Ontario, Canada

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-04
Primary Completion
2018-04-24
Completion
2018-04-30
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227848 on ClinicalTrials.gov