Clinical trial NCT03227848: eMurmur ID - Clinical Performance Evaluation
Official title: eMurmur ID - Clinical Performance Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Murmurs
Pathologic Murmurs
Innocent Murmurs
Congenital Heart Defect
Systolic Murmurs
Diastolic Murmurs
Lead sponsor: CSD Labs GmbH
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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).

Primary outcomes:
measure: eMurmur ID sensitivity and specificity
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
Study officials:
affiliation: Children's Hopsital of Eastern Ontario, Canada
name: Lillian Lai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai LS, Redington AN, Reinisch AJ, Unterberger MJ, Schriefl AJ. Computerized Automatic Diagnosis of Innocent and Pathologic Murmurs in Pediatrics: A Pilot Study. Congenit Heart Dis. 2016 Sep;11(5):386-395. doi: 10.1111/chd.12328. Epub 2016 Mar 15.