Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Yonsei University
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
19+ years
Phase:
PHASE3
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 a...
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 compari...
Eligibility Criteria
Inclusion
- Male and female subjects aged 19 years or older
- Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06873828
Start Date
March 1 2025
End Date
October 1 2025
Last Update
March 13 2025
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