NCT06873828尚未招募3 期
Evaluation of the Efficacy and Safety of Wearable ECG (AT-Patch) in Patients With Hypertrophic Cardiomyopathy Requiring 48-Hour Holter Monitoring : A Prospective Superiority Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials
研究概览
简要总结
- 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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 19 years or older
- •Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination
排除标准
- •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
结局指标
主要结局
Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials
时间窗: 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)
次要结局
- 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))
- 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 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))
- 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))
- Arrhythmia detection rate by test group (ATP-C75, ATP-C135)(■ATP-C75 vs ATP-C135 ( 7days vs 14days ))
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