Study to validate the accuracy of the application to diagnosis the arrhythmia

JRCT ID: jRCT1052220115

Registered date:17/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Atrial Fibrillation
• Date of first enrollment: 13/02/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Patients who wear the wearable sensors and apple watch to diagnosis arrhythmia during measurement of 12-lead electrocardiogram.

Outcome(s)

• Primary Outcome: The accuracy of the application to diagnosis the severity of arrhythmia for arrhythmia detected by 12-lead electrocardiogram
• Secondary Outcome: The comparison of diagnostic performance between tthe application to diagnosis the severity of arrhythmia and apple watch

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients who received 12-lead electrocardiogram during January 1st in 2023 and December 31st in 2023.

Exclude criteria

Patients who are disable to perform 12-lead electrocardiogram and wearable sensors
Patients with pacemakers implantation
Patients who are regarded as not suitable for this study by the attending physicians

Related Information

• Primary Sponsor: Ono Koh
• Source(s) of Monetary Support: Kyoto innovative medical technology research and development furtherance business