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Not yet recruitingNCT07870837Japan H2HUpdated Oct 19, 2026

Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan

An interventional study of Application of ambulatory cardiac monitor in Atrial Fibrillation (AF), Atrial Flutter and Supraventricular Tachycardia (SVT), sponsored by iRhythm Technologies, Inc.. Not yet recruiting at 4 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by iRhythm Technologies, Inc. · Not applicable, Interventional, and Diagnostic

Updated Oct 19, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Atrial Fibrillation (AF)
  • Atrial Flutter
  • Supraventricular Tachycardia (SVT)
  • Ventricular Tachycardia (VT)
  • Ventricular Fibrillation
  • Atrioventricular Block, Second and Third Degree
  • Complete Heart Block
  • Arrhythmias Cardiac
  • Cardiac Pause
  • Syncope and Collapse
  • Dizzyness
  • Fainting
  • Bradycardia
  • Sinus Bradycardia

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
03

In context

Atrial Fibrillation

3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.

This study's planned enrollment of 130 is below the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

iRhythm Technologies, Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participant is 18 years of age and older
  2. Participant has reported symptoms that would prompt ambulatory ECG monitoring (i.e. palpitations, dizziness or lightheadedness, syncope or presyncope, shortness of breath, or asymptomatic)
  3. Participant is prescribed Heartnote device as part of clinical care
  4. Participant is willing and able to provide informed consent and able to complete all visits for this study

Exclusion criteria

Exclusion Criteria:

  1. Participant has known permanent or persistent (i.e., 100% burden) atrial fibrillation (AF)
  2. Participants in whom inpatient monitoring should be prescribed.
  3. Participant has a known allergy to adhesives.
  4. Participant has a current skin infection or injury at location for study device placement.
  5. 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.
  6. Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.
  7. Participant with implantable cardiac defibrillator, pacemaker, or implantable loop recorders.
  8. Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
  9. Participant is a member of a vulnerable population.
  10. Participant is a current or prior employee of iRhythm.
  11. 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.
  12. Participant does not have the competency to wear the device for the prescribed monitoring period.
  13. Participant does not have the ability to consent for themselves (i.e., no LARs)
  14. Participant is unable or unwilling to participate or comply with study protocol.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Simultaneous wear of ECG patches

    Single arm involving two simultaneously worn ambulatory ECG patch monitoring systems on patients; Zio® monitor and Heartnote®.

    Diagnostic Test: Application of ambulatory cardiac monitor

Interventions

  • Diagnostic testApplication of ambulatory cardiac monitor

    Application of a second ambulatory cardiac monitor to be worn simultaneously with the standard of care monitor.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Enrollment through day 7

07

Study locations

4 sites
  • Gifu Heart Center
    Gifu, 5008384, Japan
    • Taiji Miyake, Physician · Contact · miyake@heart-center.or.jp · 058-213-0489
    • Taiji Maiyake, cardiology · Principal investigator
  • Ogaki City Hospital
    Gifu, 5038502, Japan
  • Fujita Health University Bantane Hospital
    Nagoya, 4548509, Japan
    • Eiichi Watanabe, Physician · Contact · enwatan@fujita-hu.ac.jp · 052-321-8171
    • Eiichi Watanabe, Cardiology · Principal investigator
  • Nagoya Heart Center
    Nagoya, 4610045, Japan
    • Koyo Sato, Physician · Contact · ksatoh425@gmail.com · 052-719-0810
    • Koyo Sato, cardiology · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 242 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's planned 6 months is below that.

Counting every sponsor, half of 1,031 studies reached it within 34 months; a quarter within 18 and three quarters within 54.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2026
First posted
Oct 13, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Also revised
primary outcomes
Registered
First appeared on the registry
Oct 13, 2026
Show all 2 updates
  1. Oct 19, 2026
    Primary outcomes Revised (2 changes)
    + 2 other changes: responsible party and secondary outcomes
  2. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07870837
Lead sponsor
iRhythm Technologies, Inc.
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 19, 2026

Study contacts

Ranae Hoeft
Contact
ranae.hoeft@irhythmtech.com
(224) 543-4243
Chevy Brown
Contact
chevy.brown@irhythmtech.com
Eiichi Watanabe, MD
principal investigator · Fujita University Bandane Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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iRhythm Technologies, Inc.

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