Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data

Sponsor
HUINNO Co., Ltd
Study ID
NCT07722078
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Atrial Fibrillation New Onset

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using single-lead electrocardiogram data. A total of 797 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. The performance of SMD-AFECG will be evaluated separately for new-onset atrial fibrillation in patients without a previous history of atrial fibrillation (NOAF) and atrial fibrillation episodes in patients with a previous history of atrial fibrillation (RAF). Two physicians blinded to the software results will review the electrocardiogram data and relevant medical records to establish the reference-standard classification. The blinded electrocardiogram datasets will then be analyzed using SMD-AFECG, and the software-generated predictions will be compared with the reference standard to evaluate the area under the receiver operating characteristic curve for NOAF and RAF.

Key Dates

First listed
Jul 23, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
797 participants (estimated)

Arms

  • Arm: NOAF Positive Group
    Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation that include the first atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.
  • Arm: NOAF Negative Group
    Single-lead electrocardiogram datasets from patients without a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.
  • Arm: RAF Positive Group
    Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation that include an atrial fibrillation episode. The datasets include an atrial fibrillation-free electrocardiogram period before the onset of atrial fibrillation and electrocardiogram data following its onset. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.
  • Arm: RAF Negative Group
    Single-lead electrocardiogram datasets from patients with a previous history of atrial fibrillation and without an atrial fibrillation episode during the predefined assessment period. The datasets include a continuous atrial fibrillation-free electrocardiogram period before a selected index time and electrocardiogram data following the index time. SMD-AFECG will be retrospectively applied to estimate the risk of atrial fibrillation occurring within 2 hours.

Primary Outcome Measure

AUROC of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours [ Time Frame: During the AF-free ECG window immediately preceding AF onset for positive cases or the selected index time for negative cases (up to 2 hours) ]

Central Contacts

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