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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03602742
• Other study ID #: SIGEZYZ20170828
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2018
• Source: Sigknow Biomedical Co., Ltd.
• Contact: Sigknow Biomedical Co., LTD
• Phone: +886 2 27612577
• Email: ethan.kao[@]sigknow.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation

Intervention

Device:
• EZYPRO®
Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital, Taiwan	Taipei
Taiwan	Chang Gung Medical Foundation, Linkou	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Sigknow Biomedical Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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