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NCT Number: 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

* 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).

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: ■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

  2. 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

    Time frame: ■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

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

    Time frame: ■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

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

    Time frame: ■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

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

    Time frame: ■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

Study contacts

Contact information is provided by the study sponsor or research team.

Ik-Seong Cho, MD,PhD

CONTACT

[email protected]

82-10-8975-2413

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Acronym: ATP-HCM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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