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 (ATP-HCM)

Yonsei University

Status and phase: Not yet enrolling; Phase 3

Conditions: Hypertrophic Cardiomyopathy

Treatments: Device: ATP-C75; Device: ATP-C135

Study type: Interventional

Funder types: Other

Identifiers

NCT06873828

2024-3479-001

Details and patient eligibility

About

• 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).

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)