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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2025-10-31

Brief Summary

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* 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).

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Detailed Description

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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

Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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ATP-C135

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

Intervention Type DEVICE

ATP-C75

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No