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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorYonsei University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • ATP-C135

    Device

    A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 14 days.

  • ATP-C75

    Device

    A wearable long-term electrocardiogram monitoring device that monitors electrocardiograms by attaching it for up to 7 days.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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)

Time frame
ATP-C75 : 7day , ATP-C135 : 14day

Secondary outcomes

1

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

Time frame
■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
2

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

Time frame
■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)
3

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

Time frame
■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days
4

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

Time frame
■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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