NCT05725187

Prospective Validation Study of AI-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation

Prospective Validation Study of Artificial Intelligence-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to predict the occurrence of paroxysmal atrial fibrillation by finding high-risk group from normal sinus rhythm ECG through artificial intelligence-based prediction algorithm.

Detailed description

This study is a multi-center, prospective observational validation study. Patients aged 18 or above who are hospitalized at our hospital or who visited the outpatient clinic with arrhythmia symptoms (such as palpitation) after the clinical research approval will be enrolled. The normal sinus rhythm electrocardiogram (ECG) at the time of participation in the study is recorded and put into the artificial intelligence prediction algorithm. The result of risk stratification is blinded and will not be informed to both the research director and subjects. After applying wearable devices to the subject, the ECG recorded for the first week is analyzed to confirm the occurrence of paroxysmal atrial fibrillation (the gold standard for diagnosis of atrial fibrillation). When the wearable devices are removed, the 12 lead electrocardiogram will be taken again, and if it shows normal sinus rhythm electrocardiogram, then it will be put into the artificial intelligence prediction algorithm to calculate the result as well.

Conditions

• Atrial Fibrillation Paroxysmal

Interventions

Type	Name	Description
DEVICE	MobiCare	It is a 9.2g wearable electrocardiogram device, mobiCARE, in the form of a patch, and the model name is MC200M.

Timeline

• Start date: 2022-10-14
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2023-02-13
• Last updated: 2024-09-26

Locations

11 sites across 1 country: South Korea