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

NCT03602742 | Unknown

• 1 other identifier: SIGEZYZ20170828
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Keywords

Atrial Fibrillation; Arrhythmias, Cardiac; EZYPRO ECG Recorder; ECG monitor; Long term ECG monitor; 14-day ECG monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The wearing time of 14-day continuous ECG patch (Study Compliance)

  Up to14 days

Study Arms (1)

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.

Device: EZYPRO®

Interventions

EZYPRO® DEVICE

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

Also known as: 24-hour Holter

24-hour Holter and 14-day EZYPRO®

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sigknow Biomedical Co., Ltd.: lead

Study Sites (2)

Taipei Veterans General Hospital, Taiwan

Taipei, Taiwan

RECRUITING

Chang Gung Medical Foundation, Linkou

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Shien Wen

  Chang Gung Medical Foundation, Linkou

  PRINCIPAL INVESTIGATOR

• Shih-Lin Chang

  Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sigknow Biomedical Co., LTD

CONTACT

+886 2 27612577; ethan.kao@sigknow.com.tw

Sigknow Biomedical Co., LTD

CONTACT

+886 2 27612577; casey.feng@sigknow.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 27, 2018
• Study Start: March 16, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

TW (2)