Diagnostic Validation of Wearable ECG Monitoring Patch, ATP-C120
NCT ID: NCT04857268
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
320 participants
INTERVENTIONAL
2020-11-13
2023-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Atrial Fibrillation Detection Using MEMO Patch in Patients With Stroke of Unknown Cause
NCT07295769
Electrocardiogram Clinical Validation Study
NCT04842123
WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation
NCT00129545
Atrial Fibrillation Algorithms Clinical Validation Study
NCT04699812
A Clinical Trial to Evaluate the Detection of Atrial Fibrillation for an One Day Versus More Than or Equal to Eight Days Using MEMO Patch PLUS in Individuals Aged ≥ 75 Years, or Those at High Risk of Stroke
NCT05355948
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATP-C120 application
ATP-C120 will be applied to the high patients for new-onset atrial fibrillation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. patients whose calculated CHA2DS2-VASc score is ≥ 2
Exclusion Criteria
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.
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kyungpook National University Hospital
OTHER
Seoul National University Bundang Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chang-Hwan Yoon
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chang-Hwan Yoon, MD.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National Universtiy Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B-2009/634-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.