Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07217236

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Artificial Intelligence (AI) Arrhythmias, Cardiac Cardiac Implantable Electrical Devices Cardiovascular Diseases Conduction Disorder of the Heart Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. CIED implantation

    Time frame: 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 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

  5. Adverse Events Related to Continuous ECG Monitoring

    Time frame: 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.

  6. Number of CIED-Related Complications

    Time frame: Within 90 days after randomization.

Study contacts

Contact information is provided by the study sponsor or research team.

Chin Lin

CONTACT

[email protected]

+886-2-8792-3100 ext. 18574

Wen-Yu Lin

CONTACT

[email protected]

+886-2-87923311 ext. 16118

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial

Acronym: PRECISE-AI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.