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

Last updated: March 6, 2025
Sponsor: Yonsei University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Cardiovascular Disease

Congestive Heart Failure

Cardiomyopathy

Treatment

ATP-C75

ATP-C135

Clinical Study ID

NCT06873828
2024-3479-001
  • Ages > 19
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female subjects aged 19 years or older

  2. Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holterexamination

Exclusion

Exclusion Criteria:

  1. Those judged by the investigator to be unsuitable for this clinical trial or thosewho 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 implantableelectrical devices

  4. Pregnant women

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: ATP-C75
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
October 31, 2025

Study 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