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
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
Treatments tested in this trial
- AI-ECG driven echocardiography
Treatment groups
8,648 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov