eMurmur Clinical Performance Evaluation

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. Identifier: NCT03227848
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : May 15, 2018
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 is an investigational CAA system (not FDA approved) 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 equal or better compared to a similar FDA approved CAA system on market.

Condition or disease Intervention/treatment
Heart Murmurs Pathologic Murmurs Innocent Murmurs Congenital Heart Defect Systolic Murmurs Diastolic Murmurs Device: Computer Aided Auscultation

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

Intervention Details:
  • Device: Computer Aided Auscultation
    Automated digital heart sound analysis for heart murmur detection and murmur classification
    Other Name: eMurmur

Primary Outcome Measures :
  1. eMurmur 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.

Information from the National Library of Medicine

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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.

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 identifier (NCT number): NCT03227848

Contact: Andreas Schriefl, PhD

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

Additional Information:
Responsible Party: CSD Labs GmbH Identifier: NCT03227848     History of Changes
Other Study ID Numbers: eMurmur CPE
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 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: No

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