Clinical trial Recruiting at 1 site Interventional Ages 60 to 85

VALVE-AI: AI-ECG screening to find moderate or severe heart valve disease.

Official title: VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial

Run by National Defense Medical Center, Taiwan · NCT07023510 · Data updated 2026-11-12

This project will see if an AI-powered 12-lead ECG can help find moderate or severe valvular heart disease in adults aged 60–85 who get a routine ECG.

More Valvular Heart Disease trials

Quick facts

Study typeInterventional
Ages60 Years to 85 Years
SexAll
Enrollment8648 (estimated)
SponsorNational Defense Medical Center, Taiwan
Academic / other
Locations1 site (Taipei)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedJuly 1, 2026
Study endsJuly 1, 2026
Registry record updatedJune 26, 2025
Trial IDNCT07023510 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 60–85 who have had a 12-lead ECG within the past year, with no echocardiogram in the prior three years, no known valvular disease, no prior valve surgery, and not post–heart transplant.

Probably not a fit

People with a recent echocardiogram, known valvular disease, prior valve surgery, post–heart transplant status, or outside the 60–85 age range are unlikely to benefit from this screening approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized controlled trial, adult outpatients aged 60–85 receiving a standard 12-lead ECG have each ECG analyzed by a validated deep-learning AI that classifies risk for significant valvular heart disease. Participants flagged as high-risk by the AI are randomized to either receive transthoracic echocardiography (experimental arm) or continue usual clinical care without routine echo prompted by the AI result (control arm), while low-risk participants receive routine care. The primary outcome is the rate of newly detected moderate or severe VHD within 90 days post-randomization. Secondary outcomes include time to diagnosis, downstream management changes, and feasibility of integrating AI-ECG screening into outpatient workflows.

Why it matters

Potential benefit: If successful, AI-guided screening could detect clinically important valve disease earlier, enabling timelier treatment and reducing downstream complications.

How similar studies have gone: AI-ECG methods have shown promise detecting conditions like reduced ejection fraction and atrial fibrillation and some observational work suggests AI can flag valvular disease signals, but randomized trials of AI-ECG screening for VHD are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Tri-Service General Hospital
    Taipei, Taiwan
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.