Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
8648 participants
INTERVENTIONAL
2025-07-01
2026-07-01
Brief Summary
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．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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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AI-ECG
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.
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.
Usual care
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age 60-85 years of age
Exclusion Criteria
* Any known valvular heart disease
* History of any valvular surgery
* Post-heart transplant
60 Years
85 Years
ALL
No
Sponsors
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National Defense Medical Center, Taiwan
OTHER
Responsible Party
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Yu-Lan Liu
Doctor of Medicine
Locations
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Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Lin YT, Lin CS, Tsai CS, Tsai DJ, Lou YS, Fang WH, Lee YT, Lin C. Comprehensive clinical application analysis of artificial intelligence-enabled electrocardiograms for screening multiple valvular heart diseases. Aging (Albany NY). 2024 May 16;16(10):8717-8731. doi: 10.18632/aging.205835. Epub 2024 May 16.
Other Identifiers
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VALVE-AI RCT
Identifier Type: -
Identifier Source: org_study_id
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