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eMurmur ID - Clinical Performance Evaluation

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ClinicalTrials.gov Identifier: NCT03227848
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
CSD Labs GmbH

Brief 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.

Condition or disease Intervention/treatment
Heart Murmurs Pathologic Murmurs Innocent Murmurs Congenital Heart Defect Systolic Murmurs Diastolic Murmurs Device: Automated Heart Murmur Detection AI

Study Type : Observational [Patient Registry]
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: eMurmur ID - Clinical Performance Evaluation
Actual Study Start Date : January 4, 2017
Actual Primary Completion Date : April 24, 2018
Actual Study Completion Date : April 30, 2018

Intervention Details:
  • 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.
    Other Name: eMurmur ID


Primary Outcome Measures :
  1. eMurmur ID sensitivity and specificity [ Time Frame: 1 day ]

    The primary endpoints of the study are sensitivity and specificity. The clinical reference gold standard diagnosis is defined as expert physicians' diagnosis confirmed by independently interpreted echocardiogram diagnosis.

    True positive (TP), true negative (TN), false positive (FP) and false negative (FN) will be determined via comparison of the heart murmur classification results with the clinical gold standard (echocardiogram) diagnosis.




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be chosen based on the heart murmur types required to meet a specified target patient population. Pre-selection of AHA class I and AHA class III patients will be done to achieve a reasonably similar distribution of murmur types compared to a US patient population. All major pathological and innocent murmur types will be included and their occurrence depending on age will be considered. Number of participants drawn: 120 participants across all ages will be included, 75% pediatric and 25% adult.
Criteria

Inclusion Criteria:

  • All age groups of patients will be included from 1day old
  • Patients who are being followed for known congenital heart disease and are returning for follow up
  • Patients referred for a suspected heart murmur

Exclusion Criteria:

  • Mismatch between the expert physician's diagnosis (auscultation based) and the diagnosis resulting from echocardiography (independently read by a cardiologist blinded to the auscultation results). Note: both, the expert physician and echocardiography results must independently reach the same diagnosis, which is then accepted as the gold standard reference diagnosis to which both devices are compared to. This is necessary because not every pathology visible on an echocardiogram causes an audible murmur, and not every murmur heard by a medical expert might correlate to pathology.
  • Patient whose behaviour does not allow for a standard auscultation by the physician (e.g. a screaming fit).

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): NCT03227848


Locations
Canada
Children's Hospital of Eastern Ontario
Ottawa, Canada
Sponsors and Collaborators
CSD Labs GmbH
Investigators
Principal Investigator: Lillian Lai, MD Children's Hopsital of Eastern Ontario, Canada

Additional Information:
Publications:
Responsible Party: CSD Labs GmbH
ClinicalTrials.gov Identifier: NCT03227848     History of Changes
Other Study ID Numbers: OTT03
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:
Heart Defects, Congenital
Heart Murmurs
Systolic Murmurs
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Signs and Symptoms