An Open-label Study of EZYPRO® in Atrial Fibrillation Detection on ESUS Patients
NCT05089435 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2022-05-10
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
- 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.
Sponsors & Collaborators
-
Sigknow Biomedical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Li Ming Lien, PhD · Shin Kong Wu Ho-Su Memorial Hospital
-
Li Kai Tsai, PhD · National Taiwan University Hospital Hsin-Chu Branch
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-28
- Primary Completion
- 2023-03-31
- Completion
- 2023-12-31
Countries
- Taiwan
Study Locations
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