NCT06386016

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 24, 2024

Last Update Submit

April 24, 2024

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients with valvular heart disease

Other: artificial intelligence-based stethoscope

patients without valvular heart disease

Other: artificial intelligence-based stethoscope

Interventions

artificial intelligence-based stethoscopeOTHER

artificial intelligence-based stethoscope

patients with valvular heart diseasepatients without valvular heart disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with and without valvular heart disease assessed by echocardiography

You may qualify if:

  • age\>18 years
  • In the past 1 month, echocardiography was performed to diagnose valvular heart disease (positive group) and echocardiography to exclude valvular heart disease (negative group).
  • Consent to study and be able to sign informed consent

You may not qualify if:

  • After prosthetic valve replacement
  • Congenital heart disease (except bilobal aortic valve)
  • Hypertrophic Cardiomyopathy（HCM）
  • Pregnant, lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 24, 2024

First Posted

April 26, 2024

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

September 1, 2024

Last Updated

April 26, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Locations

CN(1)