eMurmur ID - Clinical Performance Evaluation

CSD Labs

Status: Completed

Conditions: Pathologic Murmurs; Innocent Murmurs; Systolic Murmurs; Congenital Heart Defect; Heart Murmurs; Diastolic Murmurs

Treatments: Device: Automated Heart Murmur Detection AI

Study type: Observational

Funder types: Other

Identifiers

NCT03227848

OTT03

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 1+ day old

Volunteers: Accepts Healthy Volunteers

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).