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
Trial Information
Current as of April 26, 2025
Not yet recruiting
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
About Yonsei University
Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported