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

Not Applicable

• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Interventions: Device: EZYPRO®

• Registration Number: NCT03602742
• Lead Sponsor: Sigknow Biomedical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-16
• Study First Submitted: 2018-05-24
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-18
• Last Update Submitted: 2018-07-18
• Study First Posted: 2018-07-27
• Last Update Posted: 2018-07-27
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
24-hour Holter and 14-day EZYPRO®	EZYPRO®	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Chang Gung Medical Foundation, Linkou; 🇨🇳 Taoyuan, Taiwan

Taipei Veterans General Hospital, Taiwan; 🇨🇳 Taipei, Taiwan