Clinical trial NCT06873828: 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
Official title: Evaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter Monitoring : A Prospective Superiority Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Detailed description: Prospective, sequential, superiority test Patients diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter monitoring.

* 48-hour Holter vs ATP-C75 (48-hour comparison/total time comparison)
* 48-hour Holter vs ATP-C135 (48-hour comparison/total time comparison)
* Comparison between IDs

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. Those with sensitive or allergic skin, skin diseases such as skin cancer or rashes
3. Those with pacemakers, implantable cardioverter-defibrillators, or other implantable electrical devices
4. Pregnant women

Primary outcomes:
measure: Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials
timeFrame: ATP-C75 : 7day , ATP-C135 : 14day
Secondary outcomes:
measure: Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device
timeFrame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
measure: 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
timeFrame: ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)
measure: User response evaluation (satisfaction) in the test group and control group after using the clinical trial medical device
timeFrame: ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days
measure: Arrhythmia detection rate in the test group and control group by hypertrophic cardiomyopathy subtype (Apical HCM, Non-apical HCM)
timeFrame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
measure: Arrhythmia detection rate by test group (ATP-C75, ATP-C135)
timeFrame: ■ATP-C75 vs ATP-C135 ( 7days vs 14days )
Other outcomes:
Locations:
Study officials:
References:
citation: 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. 2024 Sep 20:S1547-5271(24)03368-X. doi: 10.1016/j.hrthm.2024.09.040. Online ahead of print.
citation: 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.
citation: 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.