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

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac
• Intervention / Treatment: Device: EZYPRO®

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Veterans General Hospital, Taiwan
    • Contact: Ethan Kao; Phone Number: +886 2 2761 2577; Email: contact@sigknow.com.tw
  • Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Medical Foundation, Linkou
    • Contact: Ethan Kao; Phone Number: 8119 +886 2 2761 2577; Email: contact@sigknow.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 24-hour Holter and 14-day 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.	Device: EZYPRO®; Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance; Other Names: 24-hour Holter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sigknow Biomedical Co., Ltd.
• Investigators: Principal Investigator: Ming-Shien Wen, Chang Gung Medical Foundation, Linkou; Principal Investigator: Shih-Lin Chang, Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Arrhythmias, Cardiac; EZYPRO ECG Recorder; ECG monitor; Long term ECG monitor; 14-day ECG monitor
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: SIGEZYZ20170828

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No