Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO

Study Overview
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Brief Summary
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This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.

Official Title
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Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO

Conditions
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Atrial Fibrillation, Arrhythmias, Cardiac

Intervention / Treatment
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* Device: EZYPRO®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed written informed consent before enrollment into the study Are able to communicate with the investigators With suspected arrhythmia related signs and symptoms, judged by the investigators Patients intend to wear ECG moniotrs Males and females, 20 years of age or older Exclusion Criteria: Patients with skin allergies or injury, judged by investigators Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators Pregnant women Currently participating in another trial or who participated in a previous clinical trial

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 24-hour Holter and 14-day EZYPRO®<br>This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. One arm included. | Device: EZYPRO®<br>* Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance<br>* Other names: 24-hour Holter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the detection difference of any type of arrhythmia between 14-day continuous ECG patch and 24-hour Holter monitor device among patients with suspected cardiac arrhythmia events over total wearing time | The arrhythmia events of 14-day continuous ECG patch monitor (investigational device) and 24-hour Holter monitor will be analyzed by the qualified ECG technicians and determined by physician investigators at the study sites. Arrhythmia events are defined as detection of any 1 of 6 arrhythmias, including: Supraventricular tachycardia (>4 beats, not including atrial fibrillation or flutter) Atrial fibrillation/flutter (>4 beats) Pause >3 seconds Atrioventricular block (Second-degree, 2:1 or third-degree atrioventricular block, need an advanced determination by the investigators) Ventricular tachycardia (>4 beats) Polymorphic ventricular tachycardia/ventricular fibrillation In the end, all the detection will be confirmed by the investigators. McNemar's tests will be used to compare the matched pairs of proportion data. | Up to14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The wearing time of 14-day continuous ECG patch (Study Compliance) | The wearing time will be recorded as the day of 14-day continuous ECG patch removal after stating monitoring. Kaplan-Meier method will be reported for total wearing time. The mean value along with two-sided 95% confidence intervals will be report as well. | Up to14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor