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

Primary Purpose

Atrial Fibrillation, Arrhythmias, Cardiac

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EZYPRO®
Sponsored by
Sigknow Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taipei Veterans General Hospital, TaiwanRecruiting
  • Chang Gung Medical Foundation, LinkouRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

24-hour Holter and 14-day EZYPRO®

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 24, 2018
Last Updated
July 18, 2018
Sponsor
Sigknow Biomedical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03602742
Brief Title
Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
Official Title
Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sigknow Biomedical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrhythmias, Cardiac
Keywords
Atrial Fibrillation, Arrhythmias, Cardiac, EZYPRO ECG Recorder, ECG monitor, Long term ECG monitor, 14-day ECG monitor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24-hour Holter and 14-day EZYPRO®
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EZYPRO®
Other Intervention Name(s)
24-hour Holter
Intervention Description
Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Up to14 days
Secondary Outcome Measure Information:
Title
The wearing time of 14-day continuous ECG patch (Study Compliance)
Description
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.
Time Frame
Up to14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sigknow Biomedical Co., LTD
Phone
+886 2 27612577
Ext
102
Email
ethan.kao@sigknow.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Sigknow Biomedical Co., LTD
Phone
+886 2 27612577
Ext
134
Email
casey.feng@sigknow.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shien Wen
Organizational Affiliation
Chang Gung Medical Foundation, Linkou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shih-Lin Chang
Organizational Affiliation
Veterans General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital, Taiwan
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Kao
Phone
+886 2 2761 2577
Email
contact@sigknow.com.tw
Facility Name
Chang Gung Medical Foundation, Linkou
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ethan Kao
Phone
+886 2 2761 2577
Ext
8119
Email
contact@sigknow.com.tw

12. IPD Sharing Statement

Learn more about this trial

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

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