The VALVE-AI Trial

ConditionValvular Heart Disease Patients

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60-85

SponsorNational Defense Medical Center, Taiwan

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

At least one 12-lead ECG within 1 year

Age 60-85 years of age

Disqualifiers

Documented echocardiography within 3 years before indexed ECG

Any known valvular heart disease

History of any valvular surgery

Post-heart transplant

Trial design

Design model

Parallel

Treatments tested in this trial

AI-ECG driven echocardiography
Diagnostic test
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.

Treatment groups

8,648 Participants

are divided into 2 treatment groups

Group A: AI-ECGExperimental treatment 1 intervention

Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

Composite of Any Moderate or Severe VHD by Echocardiography

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).

Time frame