Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120

Study Overview
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Brief Summary
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A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. This study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

Detailed Description
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The prevention of stroke associated with atrial fibrillation is a leading global health concern. This devastating event is largely preventable with anticoagulant therapy. Therefore, the early detection and accurate diagnosis of arrhythmia are crucial for prevention of adverse outcome. However, because atrial fibrillation is often intermittent and mostly asymptomatic, it is difficult to capture an excise event. Conventional electrocardiogram (ECG) monitoring devices including multi-lead portable ECG monitoring device, event-detection monitoring device, and implantable ECG monitoring device are useful for early detection of atrial fibrillation, but these devices have various drawbacks such as requirement of multiple out-patient visits and need of invasive implantation of devices. A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. It has recently demonstrated its diagnostic capability and safety compared to the conventional ECG monitoring systems . Yet, it has not widely used in real-world. So, this study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

Official Title
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Diagnostic Validation of Wearable Continuous ECG Monitoring Patch, ATP-C120, in High Risk Patients for New-onset Atrial Fibrillation

Conditions
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Atrial Fibrillation New Onset

Intervention / Treatment
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* Device: wearable continuous ECG monitoring patch, ATP-C120


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who provide written and informed consent to participate patients whose calculated CHA2DS2-VASc score is ≥ 2 Exclusion Criteria: subjects previously diagnosed with atrial fibrillation subjects implanted pacemaker, cardioverter-defibrillator, or any electrical devices subjects had skin problems such as allergic contact dermatitis female patients who are pregnant, or lactating status.

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Experimental: ATP-C120 application<br>ATP-C120 will be applied to the high patients for new-onset atrial fibrillation | Device: wearable continuous ECG monitoring patch, ATP-C120<br>* ATP-C120 is a novel, single-lead ECG monitoring device which can continuously monitor the ECG signal as long as 14 days (11 days if the device is connected to the smartphone via Bluetooth) when attached to skin adjacent to the heart of patients. It weighs about 8.3 g, with a size of 84 × 39 × 8.3 mm. When the device is attached to the patient, several predefined methods were utilized to prevent the occurrence of noise or signal loss. First, the skin was cleansed and disinfected using a 70% ethanol solution. Skin hair was removed if needed. Then the protection film was removed from the patient-side surface of the device. The device is placed at the left 3rd intercostal space 45 degrees tilted toward the inside.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new-onset atrial fibrillation | new-onset atrial fibrillation recognized by ATP-C120 patch device | 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new-onset atrial fibrillation | new-onset atrial fibrillation recognized by conventional ECG monitoring device | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Wearable Electronic Device, Arrhythmia