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NCT06386016 Clinical Trial

Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope

Valvular Heart Disease Clinical Trial

Official title:
Detection of Valvular Heart Disease Using Artificial Intelligence-based Stethoscope

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06386016
Other study ID # Stethoscope study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2024
Est. completion date September 1, 2024

Study information
Verified date April 2024
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to develop a deep learning-based application of heart sounds in the diagnosis of valvular heart disease, which can be used to screen patients with valvular heart disease and promote earlier clinical monitoring and intervention.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date September 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. age>18 years 2. In the past 1 month, echocardiography was performed to diagnose valvular heart disease (positive group) and echocardiography to exclude valvular heart disease (negative group). 3. Consent to study and be able to sign informed consent Exclusion Criteria: 1. After prosthetic valve replacement 2. Congenital heart disease (except bilobal aortic valve) 3. Hypertrophic Cardiomyopathy(HCM) 4. Pregnant, lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• artificial intelligence-based stethoscope
artificial intelligence-based stethoscope

Locations
Country Name City State
China First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Xiao-dong Zhuang

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary valvular heart disease Reports therefore graded VHD as none, mild, moderate, severe, or critical, with additional borderline categories (eg, moderate to severe) also allowed 10 months
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