The VALVE-AI Trial

National Defense Medical Center, Taiwan

Status: Enrolling

Conditions: Valvular Heart Disease Patients

Treatments: Diagnostic Test: AI-ECG driven echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT07023510

VALVE-AI RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,648 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,648 participants in 2 patient groups

AI-ECG

Experimental group

Description:

Participants whose electrocardiogram is classified as high-risk for moderate or severe valvular heart disease (VHD) by the artificial intelligence-powered electrocardiogram (AI-ECG) system will receive additional transthoracic echocardiography, regardless of whether the treating physician suspects VHD based on symptoms or physical examination. Low-risk participants continue with routine care without additional intervention.

Treatment:

Diagnostic Test: AI-ECG driven echocardiography

Usual care

No Intervention group

Description:

Participants whose electrocardiogram is classified as high-risk for moderate or severe valvular heart diseases (VHD) by the artificial intelligence-powered electrocardiogram (AI-ECG) system receive standard care according to routine clinical practice. Transthoracic echocardiography is arranged only if the treating physician deems it clinically necessary based on the symptoms, physical examination, , or other non-AI findings. Low-risk participants continue with routine care without additional intervention.