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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03273803
Other study ID # B-1609-361-303
Secondary ID
Status Completed
Phase N/A
First received September 3, 2017
Last updated September 5, 2017
Start date August 24, 2016
Est. completion date June 8, 2017

Study information

Verified date September 2017
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators performed a proof-of-concept study enrolling subjects with normal and pathologic heart sounds. Heart sound was recorded by auscultation on the skin of the chest wall using three smartphones: Samsung Galaxy S5 and Galaxy S6, and LG G3 . Recorded heart sounds were processed and classified by a diagnostic algorithm using convolutional neural networks.


Description:

Heart sound recording was done by researchers who were familiar with the use of the app and understand the principles of cardiac auscultation.

Reference heart sounds were recorded using an electronic stethoscope (3M™ Littmann® Electronic Stethoscope Model 3200). Study devices included Samsung Galaxy S5 (model SM-G900), Galaxy S6 (SM-G920), and LG G3 (LG-F400).


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date June 8, 2017
Est. primary completion date October 31, 2016
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- subjects who gave informed consent

- subjects who are 18 years old or older and had performed ECG and echocardiography during the previous 6 months.

Exclusion Criteria:

- subjects with impairment of cognition

Study Design


Related Conditions & MeSH terms

  • Cardiovascular Physiological Phenomena

Intervention

Diagnostic Test:
Heart sound recording using smartphone application
Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital Korea Advanced Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of "CPstethoscope" in interpretation of heart sounds specificity, sensitivity, negative predictive value, positive predictive value 0
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