Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorNational Defense Medical Center, Taiwan

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

11,492 Participants
are divided into 2 treatment groups
Group A: AI-ECG predictionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Within 180 days after randomization

Secondary outcomes

1

Number of High-Grade Atrioventricular Block

Time frame
Within 90 days after randomization
2

Number of Complete Atrioventricular Block

Time frame
Within 90 days after randomization
3

Number of Sick Sinus Syndrome

Time frame
Within 90 days after randomization
4

Number of Ventricular Arrhythmia

Time frame
Within 90 days after randomization

Other outcomes

Sponsors and contacts

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