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Prospective, sequential, superiority test Patients diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter monitoring.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials |
| ATP-C75 : 7day , ATP-C135 : 14day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ik-Seong Cho, MD,PhD | Contact | 82-10-8975-2413 | IKSUNGCHO@yuhs.ac |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39307380 | Background | Rowin EJ, Das G, Madias C, Hsu M, Crosson L, Turakhia MP, Maron BJ, Maron MS. Extended ambulatory ECG monitoring enhances identification of higher-risk ventricular tachyarrhythmias in patients with hypertrophic cardiomyopathy. Heart Rhythm. 2025 Jul;22(7):1696-1704. doi: 10.1016/j.hrthm.2024.09.040. Epub 2024 Sep 20. | |
| 27567133 |
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The individual data of the subjects will be pseudonymized/anonymized in accordance with ICH GCP and recorded in the case record sheet, and only the participating researchers will be able to access the data. Monitoring will be conducted by a monitor designated by the client to conduct SDV, and the CRF for which SDV has been completed will be collected at the end of the study with the signature of the PI.
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| 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 | ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison) |
| 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 | ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days |
| 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 | ■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) | Comparison of control and test period (48hrs vs total time) Comparison by disease type Comparison of test period | ■ATP-C75 vs ATP-C135 ( 7days vs 14days ) |
| Weissler-Snir A, Chan RH, Adler A, Care M, Chauhan V, Gollob MH, Ziv-Baran T, Fourey D, Hindieh W, Rakowski H, Spears DA. Usefulness of 14-Day Holter for Detection of Nonsustained Ventricular Tachycardia in Patients With Hypertrophic Cardiomyopathy. Am J Cardiol. 2016 Oct 15;118(8):1258-1263. doi: 10.1016/j.amjcard.2016.07.043. Epub 2016 Jul 29. |
| 29657588 | Background | Bansal A, Joshi R. Portable out-of-hospital electrocardiography: A review of current technologies. J Arrhythm. 2018 Feb 23;34(2):129-138. doi: 10.1002/joa3.12035. eCollection 2018 Apr. |
| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
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