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The VALVE-AI Trial

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 26, 2025 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoint revisedv2 Show 4 more changesShow less
    • Interventions: Transthoracic echocardiography (Diagnostic Test) to AI-ECG driven echocardiography (Diagnostic Test)
    • Secondary endpoints revised (5)
    • Study description expanded, about 206 words
    • Publications: details revised at 1 of 1 entry
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07023510
Lead Sponsor National Defense Medical Center, Taiwan
Conditions
(from sponsor)		 Valvular Heart Disease Patients
Enrollment 8,648 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov