NCT04857268

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

April 20, 2021

Last Update Submit

April 22, 2021

Conditions

Atrial Fibrillation New Onset

Keywords

ArrhythmiaAtrial FibrillationWearable Electronic Device

Outcome Measures

Primary Outcomes (1)

  • Rate of new-onset atrial fibrillation

    new-onset atrial fibrillation recognized by ATP-C120 patch device

    11 days

Secondary Outcomes (1)

  • Rate of new-onset atrial fibrillation

    6 month

Study Arms (1)

ATP-C120 application

EXPERIMENTAL

ATP-C120 will be applied to the high patients for new-onset atrial fibrillation

Device: wearable continuous ECG monitoring patch, ATP-C120

Interventions

wearable continuous ECG monitoring patch, ATP-C120DEVICE

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.

ATP-C120 application

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National Universtiy Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Related Publications (9)

  • Choi W, Kim SH, Lee W, Kang SH, Yoon CH, Youn TJ, Chae IH. Comparison of Continuous ECG Monitoring by Wearable Patch Device and Conventional Telemonitoring Device. J Korean Med Sci. 2020 Nov 16;35(44):e363. doi: 10.3346/jkms.2020.35.e363.

    PMID: 33200590BACKGROUND

  • Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.

    PMID: 24963566RESULT

  • Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

    PMID: 11343485RESULT

  • Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007.

    PMID: 17577005RESULT

  • Potpara TS, Lane DA, Lip GY. Optimizing stroke prevention in atrial fibrillation: better adherence and compliance from patients and physicians leads to better outcomes. Europace. 2015 Apr;17(4):507-8. doi: 10.1093/europace/euv041. No abstract available.

    PMID: 25833879RESULT

  • Waks JW, Buxton AE. Risk Stratification for Sudden Cardiac Death After Myocardial Infarction. Annu Rev Med. 2018 Jan 29;69:147-164. doi: 10.1146/annurev-med-041316-090046.

    PMID: 29414264RESULT

  • Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.

    PMID: 22236222RESULT

  • Camm AJ, Corbucci G, Padeletti L. Usefulness of continuous electrocardiographic monitoring for atrial fibrillation. Am J Cardiol. 2012 Jul 15;110(2):270-6. doi: 10.1016/j.amjcard.2012.03.021. Epub 2012 Apr 12.

    PMID: 22503584RESULT

  • Kwun JS, Lee JH, Park BE, Park JS, Kim HJ, Kim SH, Jeon KH, Cho HW, Kang SH, Lee W, Youn TJ, Chae IH, Yoon CH. Diagnostic Value of a Wearable Continuous Electrocardiogram Monitoring Device (AT-Patch) for New-Onset Atrial Fibrillation in High-Risk Patients: Prospective Cohort Study. J Med Internet Res. 2023 Sep 18;25:e45760. doi: 10.2196/45760.

    PMID: 37721791DERIVED

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial Fibrillation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chang-Hwan Yoon, MD.,Ph.D.

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ju-Seung Kwun, MD.

CONTACT

+82-10-9279-5372jkwun0413@gmail.com

Ga-hyun Lee, RN

CONTACT

+82-10-2534-3761R2631@snubh.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 23, 2021

Study Start

November 13, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)