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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-ECG prediction | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-ECG driven ECG monitoring | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CIED implantation | 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). | Within 180 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of High-Grade Atrioventricular Block | Within 90 days after randomization | |
| Number of Complete Atrioventricular Block | Within 90 days after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chin Lin | Contact | +886-2-8792-3100 | 18574 | xup6fup0629@gmail.com |
| Wen-Yu Lin | Contact | +886-2-87923311 | 16118 | salmon.lin1019@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Number of Sick Sinus Syndrome |
| Within 90 days after randomization |
| Number of Ventricular Arrhythmia | Within 90 days after randomization |
| Adverse Events Related to Continuous ECG Monitoring | 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. | Within 90 days after randomization. |
| Number of CIED-Related Complications | Within 90 days after randomization. |