Under construction – not a live service
Sign in
Not yet taking people in JapanNo phase

Comparing two wearable heart rhythm monitors for detecting irregular heartbeats in Japan

Compares two wearable patch heart monitors for finding abnormal heart rhythms in adults.

Key facts

Who runs it
iRhythm Technologies, Inc.
Where
Gifu and Nagoya, JapanSee the 4 sites
Trial code
Registry title
Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Status
Not yet recruiting
People taking part
130 people, planned
Started
30 Sept 2026
Expected to end
31 Dec 2027
Type of study
Interventional
Treatments tested
  • Application of ambulatory cardiac monitor
Record updated
19 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have symptoms that call for a heart rhythm patch monitor and who are prescribed the Heartnote device as part of their care.

Age
18 years and older
Sex
All sexes can join.

Main reasons for not taking part

  • Known permanent or persistent atrial fibrillation (100% burden)
  • Needs inpatient monitoring
  • Known allergy to adhesives, or a skin infection or injury where the device goes
  • Implanted defibrillator, pacemaker or loop recorder, or a neuro-stimulator
  • Cannot give consent for themselves, or cannot wear the device for the full monitoring period

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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 take part

  • Participant is a current or prior employee of iRhythm
  • 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
  • Participant with implantable cardiac defibrillator, pacemaker, or implantable loop recorders
  • 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 has known permanent or persistent (i.e., 100% burden) atrial fibrillation (AF)
  • Participants in whom inpatient monitoring should be prescribed
  • Participant has a neuro-stimulator, as it may disrupt the quality of ECG data
  • Participant is a member of a vulnerable population
  • 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

Where in Japan

  • Gifu Heart CenterGifu, JapanContact: Taiji Miyake, PhysicianNo longer taking part
  • Ogaki City HospitalGifu, JapanContact: Itsuro Morishima, PhysicianNo longer taking part
  • Fujita Health University Bantane HospitalNagoya, JapanContact: Eiichi Watanabe, PhysicianNo longer taking part
  • Nagoya Heart CenterNagoya, JapanContact: Koyo Sato, PhysicianNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • Simultaneous wear of ECG patchesTreatment being tested

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

    Treatment: Application of ambulatory cardiac monitor

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Head-to-Head Comparison of Ambulatory Cardiac ECG Monitors in Japan
Plain-language title
Comparing two wearable heart rhythm monitors for detecting irregular heartbeats in JapanGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 October 2026