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RecruitingNot ApplicableNCT07023510

The VALVE-AI Trial

VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial

Sponsor

National Defense Medical Center, Taiwan

Enrollment

8,648 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Valvular Heart Disease Patients

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.

Eligibility

Min Age: 60 YearsMax Age: 85 Years

Inclusion Criteria2

  • At least one 12-lead ECG within 1 year
  • Age 60-85 years of age

Exclusion Criteria4

  • Documented echocardiography within 3 years before indexed ECG
  • Any known valvular heart disease
  • History of any valvular surgery
  • Post-heart transplant

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Interventions

DIAGNOSTIC_TESTAI-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

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NCT07023510