NCT07217236

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 11,492 (estimated)
• Sponsor: National Defense Medical Center, Taiwan · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized controlled trial designed to evaluate the impact of an AI-ECG strategy on the identification of patients requiring CIEDs. The ECGs of eligible participants will be analyzed by a previously validated deep learning algorithm. Those classified as high-risk by the AI-ECG system will be allocated at random into either the intervention group or the control group. In the intervention group, the physicians will be alerted by the AI-ECG system, and the participants will be proactively contacted to receive ambulatory continuous ECG monitoring for up to 7 days. In the control group, the participants will continue with usual clinical care, and treating physicians will not have access to the AI-ECG results before the end of this study. To ensure accuracy, the reference standards for device indications will be performed by a panel of experienced cardiologists without access to the AI-generated reports.

Conditions

• Artificial Intelligence (AI)
• Cardiac Implantable Electrical Devices
• Conduction Disorder of the Heart

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	AI-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.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2025-10-15
• Last updated: 2025-12-12

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study