NCT06873828

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertrophic Cardiomyopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-03-13
• Last updated: 2025-03-13