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

Phase 3

Not yet recruiting

• Conditions: Hypertrophic Cardiomyopathy

• Registration Number: NCT06873828
• Lead Sponsor: Yonsei University

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

Study Timeline

• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-13
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials	ATP-C75 : 7day , ATP-C135 : 14day	* 48-hour Holter vs ATP-C75 (48-hour comparison/7days); * 48-hour Holter vs ATP-C135 (48-hour comparison/14days)

Secondary Outcome Measures

Name	Time	Method
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 control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u; ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
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	Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u; ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
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)	Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u; ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
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)	Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u; ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Arrhythmia detection rate by test group (ATP-C75, ATP-C135)	■ATP-C75 vs ATP-C135 ( 7days vs 14days )	Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period