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

NCT07217236 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11492

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • National Defense Medical Center, Taiwan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217236 on ClinicalTrials.gov