The VALVE-AI Trial

Not Applicable

Recruiting

• Conditions: Valvular Heart Disease Patients

• Registration Number: NCT07023510
• Lead Sponsor: National Defense Medical Center, Taiwan

Brief 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.

Detailed Description

This randomized controlled trial investigates the effectiveness of an artificial intelligence-powered electrocardiogram (AI-ECG) system for early screening of moderate or severe valvular heart disease (VHD) in adults receiving routine ECG examinations. The study population consists of adult outpatients undergoing a standard 12-lead ECG for any clinical indication. Each ECG is analyzed by a validated deep learning algorithm that automatically classifies the patient's risk for significant VHD.

Participants identified as high-risk by the AI-ECG system are randomized into either an experimental group or a control group. In the experimental group, high-risk participants undergo transthoracic echocardiography to confirm or exclude moderate or severe VHD. In the control group, high-risk participants continue with usual clinical care without additional echocardiographic screening based solely on the AI-ECG result. Low-risk participants in both groups receive routine care without additional intervention.

The primary aim is to determine whether AI-guided ECG screening, coupled with targeted echocardiography in the experimental group, increases the detection rate of clinically significant VHD compared to usual care. Secondary objectives include evaluating the impact on timely diagnosis, downstream clinical management, and the feasibility of integrating AI-ECG screening into routine outpatient workflows.

The study will follow participants for up to 90 days post-randomization to assess the detection rate and related outcomes.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-06-08
• Study First Posted: 2025-06-17
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 8648

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of Any Moderate or Severe VHD by Echocardiography	Within 90 days after randomization.	The composite endpoint is defined as detecting any moderate or severe VHD by echocardiography, including mitral regurgitation (MR), aortic regurgitation (AR), aortic stenosis (AS), and tricuspid regurgitation (TR).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Moderate or Severe MR by Echocardiography	Within 90 days after randomization.
Number of Participants with Moderate or Severe AR by Echocardiography	Within 90 days after randomization.
Number of Participants with Moderate or Severe AS by Echocardiography	Within 90 days after randomization.
Number of Participants with Moderate or Severe TR by Echocardiography	Within 90 days after randomization.
Number of Participants with Other Cardiac Diseases by Echocardiography	Within 90 days after randomization.	The endpoint measures the number and proportion of atrial septal defect, ventricular septal defect, cardiac tamponade, and large pericardial effusion.

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan