Artificial Intelligence (AI), Cardiac Implantable Electrical Devices, Conduction Disorder of the Heart
Conditions
Brief 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.
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.
Sponsors
National Defense Medical Center, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIED implantation | Within 180 days after randomization | The number of participants who undergo CIED implantation within the study period. The CIEDs include conventional transvenous pacemakers, leadless pacemakers, and implantable cardioverter-defibrillators (encompassing transvenous, subcutaneous, and extravascular systems). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complete Atrioventricular Block | Within 90 days after randomization | — |
| Number of Sick Sinus Syndrome | Within 90 days after randomization | — |
| Number of High-Grade Atrioventricular Block | Within 90 days after randomization | — |
| Adverse Events Related to Continuous ECG Monitoring | Within 90 days after randomization. | The number of adverse events associated with continuous ECG monitoring, including mild to moderate skin irritation, contact dermatitis, or discomfort at the site of patch application, as well as other procedure-related minor complications arising from extended ECG monitoring. |
| Number of CIED-Related Complications | Within 90 days after randomization. | — |
| Number of Ventricular Arrhythmia | Within 90 days after randomization | — |
Countries
Taiwan
Contacts
Primary ContactChin Lin
Backup ContactWen-Yu Lin
Outcome results
None listed