Trial reportAdvances in therapy2026
Artificial Intelligence Software for Detecting Paroxysmal Atrial Fibrillation from Sinus Rhythm Monitor ECG: Development and Clinical Trial.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
introductionDetecting paroxysmal atrial fibrillation (pAF) from sinus rhythm could enable earlier intervention and stroke prevention. We developed a deep-learning Holter electrocardiograph (ECG) algorithm and prospectively evaluated its patient-level performance against 7-day AF outcomes.
methodsWe curated 20,000 30-s sinus rhythm blocks (125 Hz) from Holter ECG data of patients with and without pAF, trained convolutional models with tenfold cross-validation, and assessed a separate validation set (n = 54; 27 pAF, 27 controls) to select the operating threshold. A multicenter prospective study then evaluated the algorithm using ten consecutive 30-s sinus rhythm blocks per patient with a 4/10 positive rule; patients with pAF underwent concurrent 7-day patch monitoring to anchor outcomes.
resultsCross-validation during development yielded mean sensitivity 84.2% and specificity 66.2%; the best tuned model achieved 84.9% sensitivity and 69.9% specificity on the separate set. In the clinical trial, among 24 patients with AF documented within 7 days and 20 controls, the device showed sensitivity 91.7% (95% confidence interval (CI) 73.0-99.0) and specificity 65.0% (40.8-84.6). No device-related adverse events occurred.
conclusionAn artificial intelligence (AI) analyzing short sinus rhythm Holter segments can identify patients who develop pAF within 7 days, supporting use as a triage tool for intensified rhythm monitoring.
trial registrationUMIN-CTR UMIN000047182.
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