Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-ECG driven ECG monitoring.
- Who it may be relevant to
- Registry conditions: Artificial Intelligence (AI), Cardiac Implantable Electrical Devices, Conduction Disorder of the Heart. Basic parameters: 65 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial
Overview
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.
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.
Primary outcome measures
- CIED implantation [Time frame: Within 180 days after randomization]
Secondary outcome measures (6)
- Number of High-Grade Atrioventricular Block [Time frame: Within 90 days after randomization]
- Number of Complete Atrioventricular Block [Time frame: Within 90 days after randomization]
- Number of Sick Sinus Syndrome [Time frame: Within 90 days after randomization]
- Number of Ventricular Arrhythmia [Time frame: Within 90 days after randomization]
- Adverse Events Related to Continuous ECG Monitoring [Time frame: Within 90 days after randomization.]
- Number of CIED-Related Complications [Time frame: Within 90 days after randomization.]
Eligibility criteria
Inclusion criteria
- At least one 12-lead ECG within 1 year
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Taiwan · 1 center
- Tri-Service General Hospital — Taipei
Identifiers
NCT: NCT07217236 · TSGH-AIECG-CIED