Evaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter MonitoringEvaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter Monitoring

NCT06873828 | Not Yet Recruiting Phase 3

• 1 other identifier: 2024-3479-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Validation of validity, superiority, and safety of data analysis results using AT-Patch compared to 48-hour Holter test results
• Number of subjects: 100 (including 10% dropout rate)
• Performance and safety were verified by simultaneously attaching a 48-hour Holter and a wearable Holter device (ATP-C75 or ATP-C135).

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials

  * 48-hour Holter vs ATP-C75 (48-hour comparison/7days) * 48-hour Holter vs ATP-C135 (48-hour comparison/14days)

  ATP-C75 : 7day , ATP-C135 : 14day

Secondary Outcomes (5)

• Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device

  ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)

• Comparison of the concordance rate of the analysis results of the simultaneous attachment time in the test group and control group after using the clinical trial medical device

  ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)

• User response evaluation (satisfaction) in the test group and control group after using the clinical trial medical device

  ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days

• Arrhythmia detection rate in the test group and control group by hypertrophic cardiomyopathy subtype (Apical HCM, Non-apical HCM)

  ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)

• Arrhythmia detection rate by test group (ATP-C75, ATP-C135)

  ■ATP-C75 vs ATP-C135 ( 7days vs 14days )

Interventions

ATP-C135 DEVICE

A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 14 days.

ATP-C75 DEVICE

A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 7 days.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 19 years or older
• Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination

You may not qualify if:

• Those judged by the investigator to be unsuitable for this clinical trial or those who may increase the risk due to participation in the clinical trial
• Those with sensitive or allergic skin, skin diseases such as skin cancer or rashes
• Those with pacemakers, implantable cardioverter-defibrillators, or other implantable electrical devices
• Pregnant women

Sponsors & Collaborators

• Yonsei University: lead

Related Publications (3)

• Rowin EJ, Das G, Madias C, Hsu M, Crosson L, Turakhia MP, Maron BJ, Maron MS. Extended ambulatory ECG monitoring enhances identification of higher-risk ventricular tachyarrhythmias in patients with hypertrophic cardiomyopathy. Heart Rhythm. 2025 Jul;22(7):1696-1704. doi: 10.1016/j.hrthm.2024.09.040. Epub 2024 Sep 20.

  PMID: 39307380 BACKGROUND

• Weissler-Snir A, Chan RH, Adler A, Care M, Chauhan V, Gollob MH, Ziv-Baran T, Fourey D, Hindieh W, Rakowski H, Spears DA. Usefulness of 14-Day Holter for Detection of Nonsustained Ventricular Tachycardia in Patients With Hypertrophic Cardiomyopathy. Am J Cardiol. 2016 Oct 15;118(8):1258-1263. doi: 10.1016/j.amjcard.2016.07.043. Epub 2016 Jul 29.

  PMID: 27567133 BACKGROUND

• Bansal A, Joshi R. Portable out-of-hospital electrocardiography: A review of current technologies. J Arrhythm. 2018 Feb 23;34(2):129-138. doi: 10.1002/joa3.12035. eCollection 2018 Apr.

  PMID: 29657588 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Central Study Contacts

Ik-Seong Cho, MD,PhD

CONTACT

82-10-8975-2413; IKSUNGCHO@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 13, 2025
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share