The VALVE-AI Trial

National Defense Medical Center, Taiwan

Status: Enrolling

Conditions: Valvular Heart Disease Patients

Treatments: Diagnostic Test: Transthoracic 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 (VHDs) 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 VHDs.

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.

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

Treatment:

Diagnostic Test: Transthoracic echocardiography

Usual care

No Intervention group