Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG
NCT ID: NCT07217236
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
11492 participants
INTERVENTIONAL
2025-11-01
2026-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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AI-ECG prediction
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.
Usual care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
65 Years
90 Years
ALL
No
Sponsors
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National Defense Medical Center, Taiwan
OTHER
Responsible Party
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Wen-Yu Lin
Associate Professor
Locations
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Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSGH-AIECG-CIED
Identifier Type: -
Identifier Source: org_study_id
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