Artificial Intelligence (AI)PRECISE-AINCT07217236
Proactive Risk Evaluation for Cardiac Implantable Electronic Device Strategy Using AI-ECG
A study testing AI-ECG driven ECG monitoring in people with Artificial Intelligence (AI) and Cardiac Implantable Electrical Devices, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Artificial Intelligence (AI), Cardiac Implantable Electrical Devices, Conduction Disorder of the Heart
- What is being tested?
- AI-ECG driven ECG monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,492 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least one 12-lead ECG within 1 year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei
Yuan-Hao Chen, +886-2-87923311, chenyh178@gmail.com
About this study
Official title: Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Artificial Intelligence (AI), Cardiac Implantable Electrical Devices, Conduction Disorder of the Heart
- Being tested
- AI-ECG driven ECG monitoring
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-ECG driven ECG monitoringDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AI-ECG prediction | Experimental | Not described Receives: Diagnostic Test: AI-ECG driven ECG monitoring |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 180 days after randomization
Secondary outcomes (6)
Number of High-Grade Atrioventricular Block
Measured: Within 90 days after randomization
Number of Complete Atrioventricular Block
Measured: Within 90 days after randomization
Number of Sick Sinus Syndrome
Measured: Within 90 days after randomization
Number of Ventricular Arrhythmia
Measured: 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.
Measured: Within 90 days after randomization.
Number of CIED-Related Complications
Measured: Within 90 days after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start1 Nov 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11,492 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Yu Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217236
- Sponsor's protocol ID
- TSGH-AIECG-CIED
- Acronym
- PRECISE-AI
- Status last verified
- Sep 2025
- First submitted
- 12 Oct 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Artificial Intelligence-Enhanced Electrocardiogram Strategy Versus Standard Care to Identify Patients Requiring Cardiac Implantable Electronic Devices: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07217236
- Acronym / sponsor ID
- PRECISE-AI / TSGH-AIECG-CIED
- Conditions
- Artificial Intelligence (AI), Cardiac Implantable Electrical Devices, Conduction Disorder of the Heart
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,492 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-ECG prediction | Experimental | Diagnostic Test: AI-ECG driven ECG monitoring |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- At least one 12-lead ECG within 1 year
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-ECG driven ECG monitoringParticipants identified as high-risk for CIED implantation by the AI-ECG system will receive a continuous cardiac rhythm monitor for up to 7 days. | Diagnostic test | AI-ECG prediction |
Primary outcome
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).
6 secondary outcomes
Number of High-Grade Atrioventricular Block
Time frame: Within 90 days after randomization
Number of Complete Atrioventricular Block
Time frame: Within 90 days after randomization
Number of Sick Sinus Syndrome
Time frame: Within 90 days after randomization
Number of Ventricular Arrhythmia
Time frame: Within 90 days after randomization
Adverse Events Related to Continuous ECG Monitoring
Time frame: Within 90 days after randomization.
Number of CIED-Related Complications
Time frame: Within 90 days after randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-ECG driven ECG monitoring in people with Artificial Intelligence (AI) and Cardiac Implantable Electrical Devices, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin Lin (+886-2-8792-3100 ext. 18574, xup6fup0629@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIED implantation (time frame: Within 180 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.