Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120

Atrial Fibrillation New Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857268
• Other study ID #: B-2009/634-003
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2021
• Source: Seoul National University Bundang Hospital
• Contact: Ju-Seung Kwun, MD.
• Phone: +82-10-9279-5372
• Email: jkwun0413[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Seoul National Universtiy Bundang Hospital	Seongnam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Kyungpook National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Côté 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 — View Citation

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 ( — View Citation

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. — View Citation

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 M — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of new-onset atrial fibrillation	new-onset atrial fibrillation recognized by ATP-C120 patch device	11 days
Secondary	Rate of new-onset atrial fibrillation	new-onset atrial fibrillation recognized by conventional ECG monitoring device	6 month