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The VALVE-AI Trial

NCT07023510 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8648

Last updated 2025-06-26

No results posted yet for this study

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.

Conditions

  • Valvular Heart Disease Patients

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • National Defense Medical Center, Taiwan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-07-01
Completion
2026-07-01

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07023510 on ClinicalTrials.gov