About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least one 12-lead ECG within 1 year
Disqualifiers
Diagnosis of sick sinus syndrome
Diagnosis of high-grade or complete atrioventricular block
Diagnosis of ventricular tachycardia or ventricular fibrillation
Post CIED implant
Trial design
Parallel
Treatments tested in this trial
AI-ECG driven ECG monitoring
Diagnostic testParticipants identified as high-risk for CIED implantation by the AI-ECG system will receive a continuous cardiac rhythm monitor for up to 7 days.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Number of High-Grade Atrioventricular Block
Number of Complete Atrioventricular Block
Number of Sick Sinus Syndrome
Number of Ventricular Arrhythmia
Sponsors and contacts
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