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.
Plain-language title generated from the registry record
Registry title: Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
Key facts
- Where
- Gifu and Nagoya, JapanSee the 4 sites
Where in Japan
- Gifu Heart CenterGifu, JapanNo longer taking part
- Ogaki City HospitalGifu, JapanNo longer taking part
- Fujita Health University Bantane HospitalNagoya, JapanNo longer taking part
- Nagoya Heart CenterNagoya, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iRhythm Technologies, Inc.
- Trial code
- NCT07870837
- Record updated
- 19 October 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.