Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120

April 22, 2021 updated by: Chang-Hwan Yoon, Seoul National University Bundang Hospital

Diagnostic Validation of Wearable Continuous ECG Monitoring Patch, ATP-C120, in High Risk Patients for New-onset Atrial Fibrillation

A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. This study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The prevention of stroke associated with atrial fibrillation is a leading global health concern. This devastating event is largely preventable with anticoagulant therapy. Therefore, the early detection and accurate diagnosis of arrhythmia are crucial for prevention of adverse outcome. However, because atrial fibrillation is often intermittent and mostly asymptomatic, it is difficult to capture an excise event.

Conventional electrocardiogram (ECG) monitoring devices including multi-lead portable ECG monitoring device, event-detection monitoring device, and implantable ECG monitoring device are useful for early detection of atrial fibrillation, but these devices have various drawbacks such as requirement of multiple out-patient visits and need of invasive implantation of devices.

A new wearable patch-type device, ATP-C120 (ATsens, Seongnam, Korea) is a novel, single-lead ECG monitoring device and can continuously monitor the ECG signal for upto 11 days. It has recently demonstrated its diagnostic capability and safety compared to the conventional ECG monitoring systems . Yet, it has not widely used in real-world. So, this study is designed to experiment its diagnostic capability of new-onset atrial fibrillation in high risk patients. Several studies reported that validated CHA2DS2-VASc score has high performance in predicting new-onset atrial fibrillation and there are over 10 percent of new-onset atrial fibrillation in patients whose calculated CHA2DS2-VASc scores are ≥ 2. Thus, through this study, the investigators sought to evaluate the validation of early detection of new-onset atrial fibrillation by ATP-C120.

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ga-hyun Lee, RN
  • Phone Number: +82-10-2534-3761
  • Email: R2631@snubh.org

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National Universtiy Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients who provide written and informed consent to participate
  2. patients whose calculated CHA2DS2-VASc score is ≥ 2

Exclusion Criteria:

  1. subjects previously diagnosed with atrial fibrillation
  2. subjects implanted pacemaker, cardioverter-defibrillator, or any electrical devices
  3. subjects had skin problems such as allergic contact dermatitis
  4. female patients who are pregnant, or lactating status.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATP-C120 application
ATP-C120 will be applied to the high patients for new-onset atrial fibrillation
Device: wearable continuous ECG monitoring patch, ATP-C120

ATP-C120 is a novel, single-lead ECG monitoring device which can continuously monitor the ECG signal as long as 14 days (11 days if the device is connected to the smartphone via Bluetooth) when attached to skin adjacent to the heart of patients. It weighs about 8.3 g, with a size of 84 × 39 × 8.3 mm.

When the device is attached to the patient, several predefined methods were utilized to prevent the occurrence of noise or signal loss. First, the skin was cleansed and disinfected using a 70% ethanol solution. Skin hair was removed if needed. Then the protection film was removed from the patient-side surface of the device. The device is placed at the left 3rd intercostal space 45 degrees tilted toward the inside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of new-onset atrial fibrillation
Time Frame: 11 days
new-onset atrial fibrillation recognized by ATP-C120 patch device
11 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of new-onset atrial fibrillation
Time Frame: 6 month
new-onset atrial fibrillation recognized by conventional ECG monitoring device
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Kyungpook National University Hospital

Investigators

  • Principal Investigator: Chang-Hwan Yoon, MD.,Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2020

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 20, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 23, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2009/634-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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