NCT06099249

Validation of ECG Measurement and Atrial Fibrillation Detection

Validation of ECG Measurement and Atrial Fibrillation Detection Function of ASUS ECG App

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 602 (estimated)
• Sponsor: ASUSTek Computer INC. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

Atrial fibrillation (AFib) is a common type of cardiac arrhythmia in clinical practice, affecting millions of people worldwide. Early detection and treatment of atrial fibrillation are crucial in preventing serious complications such as stroke and heart failure. In recent years, with the flourishing development of wearable devices and mobile technology, electrocardiogram (ECG) measurement applications embedded in smartwatches have gradually become a non-invasive and convenient method for heart rate monitoring. However, the accuracy of these devices has not yet been fully determined. This study aims to verify the ECG measurement and atrial fibrillation detection function of the ASUS ECG App. The accuracy of the ECG application in detecting atrial fibrillation and measuring ECG will be evaluated by comparison with standard 12-lead ECGs.

Detailed description

This study plans to recruit 602 adults over the age of 18. All participants will undergo heart rate measurements using both the smartwatch ECG application and the 12-lead ECG. The heart rate measurement using the ECG application will be operated by the participants themselves under the guidance of the testing personnel. The 12-lead ECG will be operated by trained medical professionals. The results of the heart rate measurement from both devices will be recorded synchronously, and the consistency of heart rate interpretation and ECG waveforms between the smartwatch ECG application and the 12-lead ECG measurement will be compared to verify the accuracy of the ECG application.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	ASUS ECG App	The procedure will commence with instructing the participants to become acquainted with the ASUS ECG App. Following this introduction, participants will be asked to sit quietly for a 5-minute resting period before undergoing a 12-lead ECG recording, which will last for approximately 30 seconds. The participant will be guided to simultaneously record a separate single-lead ECG using the ASUS ECG App. Both data streams will be synced together by the Study Staff. Each participant will undergo a total of three trials involving the simultaneous recording of a 12-lead ECG and a single-lead ECG using the ASUS ECG App.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-06-30
• Completion: 2024-12-31
• First posted: 2023-10-25
• Last updated: 2023-10-25