NCT05089435

An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients

An Open-label Study to Evaluate the Effectiveness and Safety of EZYPRO® in Atrial Fibrillation Detection in Nearly Embolic Stroke of Undetermined Source (ESUS) Patient

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Sigknow Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effectiveness and safety of the 14-day continuous ECG patch monitor (EZYPRO®) compared with a 24-hour Holter monitor in the detection of atrial fibrillation (AF) among ESUS patients.

Conditions

• Atrial Fibrillation
• Embolic Stroke of Undetermined Source

Interventions

Type	Name	Description
DEVICE	EZYPRO® ECG Recorder	EZYPRO is an ECG monitoring patch designed to enhance the arrhythmia detection rate by applying 14 days in a home setting environment.

Timeline

• Start date: 2022-03-28
• Primary completion: 2023-03-01
• Completion: 2023-12-01
• First posted: 2021-10-22
• Last updated: 2022-05-10

Locations

1 site across 1 country: Taiwan