Atrial Fibrillation (AF)Japan H2HNCT07870837
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
A study testing Application of ambulatory cardiac monitor in people with Atrial Fibrillation (AF) and Atrial Flutter, run by iRhythm Technologies, Inc. at 4 sites in Japan.
Trial summary
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT)
- What is being tested?
- Application of ambulatory cardiac monitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesJapan
- Study dates
- 30 Sep 2026to 31 Dec 2027
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 18 years of age and older
- Participant has reported symptoms that would prompt ambulatory ECG monitoring (i.e. palpitations, dizziness or lightheadedness, syncope or presyncope, shortness of breath, or asymptomatic)
- Participant is prescribed Heartnote device as part of clinical care
- Participant is willing and able to provide informed consent and able to complete all visits for this study
Who cannot join
- Participant has known permanent or persistent (i.e., 100% burden) atrial fibrillation (AF)
- Participants in whom inpatient monitoring should be prescribed.
- Participant has a known allergy to adhesives.
- Participant has a current skin infection or injury at location for study device placement.
- Participant has an external cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
- Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.
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- Participant with implantable cardiac defibrillator, pacemaker, or implantable loop recorders.
- Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
- Participant is a member of a vulnerable population.
- Participant is a current or prior employee of iRhythm.
- The local Investigator deems the participant has a condition that could limit the participant's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits.
- Participant does not have the competency to wear the device for the prescribed monitoring period.
- Participant does not have the ability to consent for themselves (i.e., no LARs)
- Participant is unable or unwilling to participate or comply with study protocol.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Chevy Brown contact
Japan4 sites
Gifu Heart Center
Gifu, 5008384
Taiji Miyake, Physician, 058-213-0489, miyake@heart-center.or.jp
Taiji Maiyake, cardiology
Ogaki City Hospital
Gifu, 5038502
Itsuro Morishima, Physician, 0584-81-3341, morishima-i@muc.biglobe.ne.jp
Itsuro Morishima, Cardiology
Fujita Health University Bantane Hospital
Nagoya, 4548509
Eiichi Watanabe, Physician, 052-321-8171, enwatan@fujita-hu.ac.jp
Eiichi Watanabe, Cardiology
Nagoya Heart Center
Nagoya, 4610045
Koyo Sato, Physician, 052-719-0810, ksatoh425@gmail.com
Koyo Sato, cardiology
About this study
Official title: Head-to-Head Comparison of Ambulatory Cardiac ECG Monitors in Japan
The goal of this clinical trial is to compare the yield of clinically actionable arrhythmias through the end of indicated wear duration in Zio monitor and Heartnote patch ECG devices.
Read the detailed description
Participants include persons who are age ≥ 18 years with symptoms to prescribe the Heartnote device as part of clinical care. The main questions it aims to answer are:
- To evaluate the yield of clinically actionable arrhythmias between Zio monitor (≤14 days) and Heartnote (≤7 days) over their respective labeled wear durations.
- To evaluate the yield of clinically actionable arrhythmias between Zio monitor and Heartnote over an aligned 7-day monitoring period.
Participants will be instructed to wear each device for the indicated wear period (7 days for Heartnote and 14 days for Zio monitor).
Participant participation is up to 14 days and consists of three on-site visits which include procedures such as device(s) application, device(s) status check/removal, and AE assessments.
The enrollment period is approximately 7 months.
Safety measures will include the assessment of skin irritation or adverse skin reactions and other adverse events (AEs). All AEs for the device/procedure will be assessed for severity and causality.
The Full Analysis Set (FAS) includes all consented participants in whom both study devices are applied and for whom there is any analyzable ECG data from both devices during its prescribed wear period. Participants will remain in the FAS regardless of early termination due to device fall-off, participant removal, discomfort, or other reasons, provided that analyzable ECG data are available.
- Conditions
- Atrial Fibrillation (AF), Atrial Flutter, Supraventricular Tachycardia (SVT), Ventricular Tachycardia (VT), Ventricular Fibrillation, Atrioventricular Block, Second and Third Degree
- Being tested
- Application of ambulatory cardiac monitor
- Keywords
- ECG Monitor Comparison, ECG Monitor, Japan, Zio Monitor, Heartnote, ECG Monitoring, palpitations, dizziness, lightheadedness, syncope, presyncope, shortness of breath, asymptomatic cardiac, cardiac, device, ECG device, Cardiac Device
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Ventricular, Ventricular Fibrillation, Atrioventricular Block, Neoplasm Metastasis, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of ambulatory cardiac monitorDiagnostic test
Application of a second ambulatory cardiac monitor to be worn simultaneously with the standard of care monitor.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous wear of ECG patches | Experimental | Single arm involving two simultaneously worn ambulatory ECG patch monitoring systems on patients; Zio® monitor and Heartnote®. Receives: Diagnostic Test: Application of ambulatory cardiac monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of clinically actionable arrhythmias identified through the end of the indicated wear duration
Yield of clinically actionable arrhythmias through the end of indicated wear duration.
Measured: Enrollment through day 14
Secondary outcomes (1)
The amount of clinically actionable arrhythmias identified through 7 days of wear.
Clinically actionable arrhythmias through 7 days of wear.
Measured: Enrollment through day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Simultaneous wear study of Zio monitor and Heartnote patch ECG devices.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iRhythm Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eiichi Watanabe, MD, Principal investigator, Fujita University Bandane Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870837
- Sponsor's protocol ID
- iRTJ-002-2025
- Acronym
- Japan H2H
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No