NCT04857268

Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120

Status unknown NA Last updated 26 April 2021

What this trial tests

NA trial testing wearable continuous ECG monitoring patch, ATP-C120 in Atrial Fibrillation New Onset in 320 participants. Status unknown.

Timeline

13 November 2020

Primary endpoint
31 December 2022

31 December 2023

Quick facts

Lead sponsor	Seoul National University Bundang Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	320
Start date	13 November 2020
Primary completion	31 December 2022
Estimated completion	31 December 2023
Sites	2 locations across South Korea

Drugs / interventions tested

• wearable continuous ECG monitoring patch, ATP-C120

Conditions studied

• Atrial Fibrillation New Onset — all drugs for Atrial Fibrillation New Onset →

Sponsor

Seoul National University Bundang Hospital

Who can join

19 and older, any sex, with Atrial Fibrillation New Onset. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Diagnostic Value of a Wearable Continuous Electrocardiogram Monitoring Device (AT-Patch) for New-Onset Atrial Fibrillation in High-Risk Patients: Prospective Cohort Study.
   Kwun JS, Lee JH, Park BE, Park JS, et al · · 2023 · cited 6× · PMID 37721791 · DOI 10.2196/45760