Status:
COMPLETED
: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
Lead Sponsor:
Nemours Children's Clinic
Conditions:
Heart Murmurs
Eligibility:
All Genders
2-18 years
Brief Summary
The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity to record heart sounds. This study will utilize these devices to see if they can differentiate between pat...
Detailed Description
It is estimated that 50-70% of all children will have had a detectable heart murmur at some point in early life, but fortunately, the vast majority of these murmurs are benign asymptomatic "innocent" ...
Eligibility Criteria
Inclusion
- Patients aged 0 to 17 years, who are able to read and speak English, and/or with parents or legal guardians who are able to read and speak English
- New patients referred to the Nemours Cardiac Center for a heart murmur, chest pain, syncope, or arrhythmia. This could include children with suspected murmurs (but ultimately found to have no murmur by a cardiologist), innocent murmurs, and pathologic murmurs.
- Patients with previously diagnosed heart condition, if they have not had any corrective surgeries and had a detectable murmur at their last clinic visit (for pathological and innocent murmurs) or had no detectable murmur at their last clinic visit (for no murmurs).
Exclusion
- Patients aged 18 and over
- Patients and/or parents who are unable to read or speak English
- Patients who have had corrective heart surgery for a heart defect
- Auscultation cannot be performed properly at all locations
- Patients not wishing to participate in study recordings
Key Trial Info
Start Date :
October 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 11 2022
Estimated Enrollment :
315 Patients enrolled
Trial Details
Trial ID
NCT04317521
Start Date
October 24 2020
End Date
March 11 2022
Last Update
March 15 2022
Active Locations (1)
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1
Nemours Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803