AzTrials
AzTrials

Hypertrophic CardiomyopathyPhase 3ATP-HCMNCT06873828

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

A Phase 3 study testing ATP-C135 and ATP-C75 in people with Hypertrophic Cardiomyopathy, run by Yonsei University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Hypertrophic Cardiomyopathy
What is being tested?
ATP-C135 and ATP-C75
Type of treatment
Medical device
How many people
100 participants
Where
No sites listed yet
Study dates
Mar 2025to Oct 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects aged 19 years or older
  • Subjects diagnosed with hypertrophic cardiomyopathy who require 48-hour Holter examination

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ik-Seong Cho, MD,PhD contact

82-10-8975-2413

IKSUNGCHO@yuhs.ac

About this study

Official title: 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).
Read the 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
Being tested
ATP-C135, ATP-C75
Medical subject headings
Cardiomyopathy, Hypertrophic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATP-C135Device

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

  • ATP-C75Device

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of arrhythmia detection rates between the test group and the control group after using a medical device for clinical trials

    • 48-hour Holter vs ATP-C75 (48-hour comparison/7days)
    • 48-hour Holter vs ATP-C135 (48-hour comparison/14days)

    Measured: ATP-C75 : 7day , ATP-C135 : 14day

Secondary outcomes (5)

  1. 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

    Measured: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)

  2. 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

    Measured: ■48-hour Holter vs ATP-C75 (48-hour comparison) ■48-hour Holter vs ATP-C135 (48-hour comparison)

  3. 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

    Measured: ■48-hour Holter : 48hrs ■ATP-C75 : 7days ■ATP-C135 : 14days

  4. 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

    Measured: ■48-hour Holter vs ATP-C75 (48-hour comparison/7days) ■48-hour Holter vs ATP-C135 (48-hour comparison/ 14days)

  5. 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

    Measured: ■ATP-C75 vs ATP-C135 ( 7days vs 14days )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873828
Sponsor's protocol ID
2024-3479-001
Acronym
ATP-HCM
Status last verified
Mar 2025
First submitted
26 Feb 2025
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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. 2025 Jul;22(7):1696-1704. doi: 10.1016/j.hrthm.2024.09.040. Epub 2024 Sep 20.

    PubMed 39307380

  • 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.

    PubMed 27567133

  • 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.

    PubMed 29657588

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ATP-C135 and ATP-C75 in people with Hypertrophic Cardiomyopathy, run by Yonsei University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ik-Seong Cho, MD,PhD (82-10-8975-2413, IKSUNGCHO@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06873828, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in