Arrhythmias, Cardiac, Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor
Brief summary
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.
Interventions
DEVICEEZYPRO®
Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance
Sponsors
Sigknow Biomedical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The wearing time of 14-day continuous ECG patch (Study Compliance) | Up to14 days | 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. |
Countries
Taiwan
Contacts
Primary ContactSigknow Biomedical Co., LTD
Backup ContactSigknow Biomedical Co., LTD
Outcome results
None listed