RecruitingNot ApplicableNCT07217236

Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG

Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial


Sponsor

National Defense Medical Center, Taiwan

Enrollment

11,492 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether an artificial intelligence-enhanced electrocardiogram (AI-ECG) strategy improves timely intervention of patients requiring cardiac implantable electronic devices (CIEDs), compared with standard clinical care.


Eligibility

Min Age: 65 YearsMax Age: 90 Years

Inclusion Criteria1

  • At least one 12-lead ECG within 1 year

Exclusion Criteria5

  • Diagnosis of sick sinus syndrome
  • Diagnosis of high-grade or complete atrioventricular block
  • Diagnosis of ventricular tachycardia or ventricular fibrillation
  • Post CIED implant
  • Heart rate below 40 beats per minute by 12-lead ECG

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Interventions

DIAGNOSTIC_TESTAI-ECG driven ECG monitoring

Participants identified as high-risk for CIED implantation by the AI-ECG system will receive a continuous cardiac rhythm monitor for up to 7 days.


Locations(1)

Tri-Service General Hospital

Taipei, Taiwan

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NCT07217236


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