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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

NCT06873828 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-03-13

No results posted yet for this study

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).

Conditions

Interventions

DEVICE

ATP-C135

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

DEVICE

ATP-C75

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2025-10-31
Completion
2025-10-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873828 on ClinicalTrials.gov