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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
ATP-C135
DeviceA wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 14 days.
ATP-C75
DeviceA wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 7 days.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials
* 48-hour Holter vs ATP-C75 (48-hour comparison/7days) * 48-hour Holter vs ATP-C135 (48-hour comparison/14days)
Secondary outcomes
Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Comparison of the concordance rate of the analysis results of the simultaneous attachment time in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
User response evaluation (satisfaction) in the test group and control group after using the clinical trial medical device
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Arrhythmia detection rate in the test group and control group by hypertrophic cardiomyopathy subtype (Apical HCM, Non-apical HCM)
Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period ATP-C135 : 14day / No f/u ■ Safety Issue ATP-C75 : 7day ATP-C135 : 14day
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: