Clinical Trial

The VALVE-AI Trial

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated June 26, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-08.
Trial Details
NCT Number NCT07023510
Lead Sponsor National Defense Medical Center, Taiwan
Conditions Valvular Heart Disease Patients
Enrollment 8,648 participants
Start Date 2025-07-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-26