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The VALVE-AI Trial
Sponsor: National Defense Medical Center, Taiwan
Summary
The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHD) in adults. The main question it aims to answer is: ．Can AI-ECG screening identify patients with significant heart valve diseases who may benefit from early echocardiography? Researchers will compare the rate of moderate or severe VHD detection between the experimental group and the control group to see if AI-ECG improve the detection rate of significant VHD. Participants will: * Be classified as high- or low-risk for VHD using an AI-ECG system * In the experimental group, high-risk participants will receive echocardiography based on AI-ECG results * In the control group, usual clinical care will be provided without routine echocardiography for AI-ECG high-risk results.
Official title: VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
8648
Start Date
2025-07-01
Completion Date
2026-07-01
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
AI-ECG driven echocardiography
The intervention utilizes a previously validated deep learning model based on 12-lead electrocardiogram (ECG) data to screen for moderate-to-severe valvular heart diseases (VHD). The model processes raw ECG signals and integrates age and sex to enhance prediction. (doi: 10.18632/aging.205835.) Participants identified as high-risk for any moderate-to-severe VHD by the algorithm of artificial intelligence-powered electrocardiogram (AI-ECG) in this intervention arm will receive transthoracic echocardiography to confirm diagnosis and guide further management.
Locations (1)
Tri-Service General Hospital
Taipei, Taiwan