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

Ki vehet részt

• 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

Ki nem vehet részt

• 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