Prospective Validation Study of AI-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation (PROVISION-AF)

Ewha Womans University

Status: Invitation-only

Conditions: Atrial Fibrillation Paroxysmal

Treatments: Device: MobiCare

Study type: Observational

Funder types: Other

Identifiers

NCT05725187

PROVISION-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be above 20 in age
• Participants are patients with symptom of arrhythmia who visited outpatient clinic or who have been hospitalized

Exclusion criteria

• Excluding patients with cardiac implantable electronic device such as pacemakers, implantable defibrillators (ICD), or cardiac resynchronization therapy (CRT).
• Excluding pregnant women and lactating women.

Trial design

600 participants in 2 patient groups

Low risk group for paroxysmal atrial fibrillation

Description:

Subject patients are above 20 in age who are hospitalized in our hospital or outpatients with arrhythmia symptoms after the clinical research approval. The sinus rhythm electrocardiogram at the time of the patient's participation in the study is put into the artificial intelligence prediction algorithm, and the risk stratification results are blinded and are not informed to both the research director and the subjects. For the low-risk group, after attaching the wearable electrocardiogram to the subject, the electrocardiogram recorded a week later is analyzed to confirm the occurrence of atrial fibrillation.

Treatment:

Device: MobiCare

High risk group for paroxysmal atrial fibrillation

Description:

Subject patients are above 20 in age who are hospitalized in our hospital or outpatients with arrhythmia symptoms after the clinical research approval. The sinus rhythm electrocardiogram at the time of the patient's participation in the study is put into the artificial intelligence prediction algorithm, and the risk stratification results are blinded and are not informed to both the research director and the subjects. For the highrisk group, after attaching the wearable electrocardiogram to the subject, the electrocardiogram recorded a week later is analyzed to confirm the occurrence of atrial fibrillation.

Treatment:

Device: MobiCare