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

ConditionHypertrophic Cardiomyopathy

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age19+

SponsorYonsei University

About this trial

* 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

Qualifiers

Male and female subjects aged 19 years or older

Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination

Disqualifiers

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

Trial design

Treatments tested in this trial

ATP-C135
ATP-C75

Treatment groups

No treatment groups listed

Locations

This trial has no locations

Sponsors and collaborators

Yonsei University

Lead sponsor

Source ClinicalTrials.gov