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 (ATP-HCM)
March 6, 2025 updated by: Yonsei University
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
- 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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ik-Seong Cho, MD,PhD
- Phone Number: 82-10-8975-2413
- Email: IKSUNGCHO@yuhs.ac
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male and female subjects aged 19 years or older
- Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: ATP-C75 : 7day , ATP-C135 : 14day
|
|
ATP-C75 : 7day , ATP-C135 : 14day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arrhythmia detection rate by test time in the test group and control group after using the clinical trial medical device
Time Frame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
|
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)
|
|
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
Time Frame: ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)
|
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
Time Frame: ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days
|
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)
Time Frame: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)
|
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)
Time Frame: ■ATP-C75 vs ATP-C135 ( 7days vs 14days )
|
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 )
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. 2024 Sep 20:S1547-5271(24)03368-X. doi: 10.1016/j.hrthm.2024.09.040. Online ahead of print.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2025
Primary Completion (Estimated)
October 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
February 26, 2025
First Submitted That Met QC Criteria
March 6, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 6, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-3479-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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