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

Launched by YONSEI UNIVERSITY · Mar 6, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a wearable heart monitoring device called the AT-Patch in patients with hypertrophic cardiomyopathy, a condition where the heart muscle becomes thickened. The trial will compare the data from the AT-Patch to the traditional 48-hour Holter monitor, which is a device that records the heart's electrical activity over two days. The goal is to see if the AT-Patch can provide similar or better results while being more convenient for patients.

To participate, individuals must be 19 years or older and have a diagnosis of hypertrophic cardiomyopathy that requires a 48-hour Holter exam. However, some people may not be eligible, such as those with certain skin conditions, those who have implantable devices like pacemakers, or pregnant women. Participants will wear both the AT-Patch and the Holter monitor at the same time for 48 hours. This trial is currently not recruiting participants, but once it begins, it will involve about 100 individuals, with a small dropout rate expected.

Gender

ALL

Eligibility criteria

• 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