Status:
COMPLETED
eMurmur ID - Clinical Performance Evaluation
Lead Sponsor:
CSD Labs GmbH
Conditions:
Heart Murmurs
Pathologic Murmurs
Eligibility:
All Genders
1+ years
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 experie...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03227848
Start Date
January 4 2017
End Date
April 30 2018
Last Update
July 18 2018
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Canada