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AI heart-tracing trial of 14,665 adults finds slightly more atrial fibrillation caught, but result is fragile
Study title: Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development (LATENT): A Randomized Controlled Trial
- Evidence type
- Randomized controlled trial
- Sample
- n = 14,665
- Sources
- 1 sourcePeer-reviewed
- Published
- 2 min read
- Truvace record
- TRV-2026-2462cite or check it
Study title: Leveraging AI-ECG Technology for Early Notification and Tracking of AF Development (LATENT): A Randomized Controlled Trial
A single-center, open-label randomized trial assigned 14,665 adults aged 40 to 85 with no prior atrial fibrillation (AF) or atrial flutter to an AI-ECG-guided strategy or usual care. The primary outcome, new AF, flutter or pre-AF atrial findings within 90 days, occurred in 54 intervention participants (0.74%) versus 35 controls (0.48%).
Read the study abstract
Background Electrocardiographic analysis aided by artificial intelligence (AI) may identify atrial electrical vulnerability during sinus rhythm. The objective of this study was to determine whether AI-enabled ECG (AI-ECG) is effective for detecting atrial fibrillation (AF), atrial flutter (AFl), or prespecified pre-AF atrial findings in a randomized trial. Methods In this single-center, open-label trial, 14 665 adults 40 to 85 years of age without previous AF/AFl were randomized to an AI-ECG-guided strategy or u…
The gain
In a randomized trial of 14,665 adults, AI-ECG-guided monitoring detected new atrial fibrillation, flutter or pre-AF findings in 0.74% of intervention participants versus 0.48% of controls.
In brief
Only 84 of 7,337 intervention participants (1.1%) were flagged as high risk by the AI, and 48 of them (57.1%) underwent Holter monitoring of up to 7 days. Each was paired with an age- and sex-matched control who received identical monitoring, which was meant to reduce ascertainment bias.
The authors describe the increase in detection as modest and statistically fragile: the odds ratio was 1.54 (95% CI, 1.01-2.37; P=0.046), and reclassifying one intervention event as a nonevent moved the P value to 0.057. The trial measured detection, not patient outcomes, and the authors call for larger trials.
Main points
- The trial randomized 7,337 adults to AI-ECG-guided care and 7,328 to usual care.
- Participants were 40 to 85 years old and had no previous AF or atrial flutter.
- The AI flagged 84 intervention participants (1.1%) and 78 control participants (1.1%) as high risk.
- Of the 84 high-risk intervention participants, 48 (57.1%) completed Holter monitoring of up to 7 days.
- The primary outcome occurred in 0.74% of the intervention group versus 0.48% of controls (odds ratio 1.54; 95% CI, 1.01-2.37).
- Reclassifying one intervention event as a nonevent changed the P value from 0.046 to 0.057.
- Reporting cardiologists were blinded to AI results and randomized assignment.
The full story
The LATENT trial tested whether AI analysis of ordinary sinus-rhythm ECGs could identify people with atrial electrical vulnerability who would benefit from targeted rhythm monitoring. Adults without previous AF or flutter were randomized to an AI-ECG-guided strategy or usual care in a single-center, open-label design.
Intervention participants whose ECG from the preceding year was judged high risk by the AI were offered Holter monitoring for up to 7 days. Each monitored participant was paired with an age- and sex-matched control, chosen before control ECGs underwent AI analysis, who received identical monitoring.
The composite outcome covered newly detected AF, flutter or pre-AF findings such as frequent premature atrial complexes, short runs of them, or nonsustained AF or flutter. The intervention effect differed by baseline AI-ECG risk.
The authors conclude the result shows a clinical application of AI-ECG risk stratification for targeted surveillance and offers a foundation for larger trials of patient outcomes. The trial is registered as NCT06847932.
Talk it overFour questions for a class, a team or the dinner table
Who gets this benefit, and who was left out of the study or story?
The gain In a randomized trial of 14,665 adults, AI-ECG-guided monitoring detected new atrial fibrillation, flutter or pre-AF findings in 0.74% of intervention participants versus 0.48% of controls.
How do we know? What can this kind of evidence show, and what can’t it?
The evidence This rests on a randomized controlled trial with a sample of 14,665, from Circulation.
What does it leave open? What else would you want to know before acting on it?
The record’s own caveat The authors say the findings were statistically fragile: reclassifying a single intervention event changed the P value from 0.046 to 0.057, and larger trials are needed to assess patient outcomes.
Have you seen AI used this way where you study, work or live? Did it go the same way?
The questions are the same on every record. The details under them are taken from this record as written.
Sources
1 on file- Circulationdoi:10.1161/circulationaha.126.083540
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The debate