Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG
PRECISE-AI
Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial
1 other identifier
interventional
11,492
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2025
CompletedFirst Posted
Study publicly available on registry
October 15, 2025
CompletedStudy Start
First participant enrolled
November 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
December 12, 2025
September 1, 2025
12 months
October 12, 2025
December 5, 2025
Conditions
Outcome Measures
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).
Within 180 days after randomization
Secondary Outcomes (6)
Number of High-Grade Atrioventricular Block
Within 90 days after randomization
Number of Complete Atrioventricular Block
Within 90 days after randomization
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
Within 90 days after randomization.
- +1 more secondary outcomes
Study Arms (2)
AI-ECG prediction
EXPERIMENTALUsual care
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- At least one 12-lead ECG within 1 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tri-Service General Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 12, 2025
First Posted
October 15, 2025
Study Start
November 1, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
December 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share