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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation Arrhythmias, Cardiac

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

EZYPRO®

Intervention Type DEVICE

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

Interventions

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EZYPRO®

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

Intervention Type DEVICE

Other Intervention Names

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24-hour Holter

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No