Hypertrophic Cardiomyopathy
Conditions
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 and safety were verified by simultaneously attaching a 48-hour Holter and a wearable Holter device (ATP-C75 or ATP-C135).
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 comparison) * 48-hour Holter vs ATP-C135 (48-hour comparison/total time comparison) * Comparison between IDs
Interventions
DEVICEATP-C135
A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 14 days.
DEVICEATP-C75
A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 7 days.
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials | ATP-C75 : 7day , ATP-C135 : 14day | * 48-hour Holter vs ATP-C75 (48-hour comparison/7days) * 48-hour Holter vs ATP-C135 (48-hour comparison/14days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device | ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days) | 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 | ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison) | 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 | ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days | 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) | ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days) | 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 by test group (ATP-C75, ATP-C135) | ■ATP-C75 vs ATP-C135 ( 7days vs 14days ) | Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period |
Contacts
Primary ContactIk-Seong Cho, MD,PhD
Outcome results
None listed