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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-hour Holter and 14-day EZYPRO® | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZYPRO® | Device | Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance |
|
| 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:
McNemar's tests will be used to compare the matched pairs of proportion data. | Up to14 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sigknow Biomedical Co., LTD | Contact | +886 2 27612577 | 102 | ethan.kao@sigknow.com.tw |
| Sigknow Biomedical Co., LTD | Contact | +886 2 27612577 | 134 | casey.feng@sigknow.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ming-Shien Wen | Chang Gung Medical Foundation, Linkou | Principal Investigator |
| Shih-Lin Chang | Veterans General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital, Taiwan | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Chang Gung Medical Foundation, Linkou | Recruiting | Taoyuan | Taiwan |
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