[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659960":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":26,"studyPopulation":18,"armGroups":27,"interventions":34,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":116,"collaborators":118,"id":121,"slug":122,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":123,"sex":129,"minAge":130,"maxAge":18,"enrollmentInfo":131,"targetDuration":18,"studyType":134,"phases":135,"briefSummary":136,"conditions":137,"keywords":152,"overallStatus":169,"whyStopped":18,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"iRhythm Technologies, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Clinically actionable arrhythmias through the end of indicated wear duration","Yield of clinically actionable arrhythmias through the end of indicated wear duration for Zio monitor and Heartnote patch ECG.","Enrollment through day 14",[14],{"measure":15,"description":16,"timeFrame":17},"Clinically actionable arrhythmias through 7 days","Clinically actionable arrhythmias through 7 days of wear for Zio monitor and Heartnote patch ECG.","Enrollment through day 7",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"NA","SINGLE_GROUP","Simultaneous wear study of Zio monitor and Heartnote patch ECG devices.","DIAGNOSTIC",{"masking":25,"maskingDescription":18,"whoMasked":18},"NONE","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:\n\n* To evaluate the yield of clinically actionable arrhythmias between Zio monitor (≤14 days) and Heartnote (≤7 days) over their respective labeled wear durations.\n* To evaluate the yield of clinically actionable arrhythmias between Zio monitor and Heartnote over an aligned 7-day monitoring period.\n\nParticipants will be instructed to wear each device for the indicated wear period (7 days for Heartnote and 14 days for Zio monitor).\n\nParticipant 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\u002Fremoval, and AE assessments.\n\nThe enrollment period is approximately 7 months.\n\nSafety measures will include the assessment of skin irritation or adverse skin reactions and other adverse events (AEs). All AEs for the device\u002Fprocedure will be assessed for severity and causality.\n\nThe 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.",[28],{"label":29,"type":30,"description":31,"interventionNames":32},"Simultaneous wear of ECG patches","EXPERIMENTAL","Single arm involving two simultaneously worn ambulatory ECG patch monitoring systems on patients; Zio® monitor and Heartnote®.",[33],"Diagnostic Test: Application of ambulatory cardiac monitor",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":18},"DIAGNOSTIC_TEST","Application of ambulatory cardiac monitor","Application of a second ambulatory cardiac monitor to be worn simultaneously with the standard of care monitor.",[29],[41],{"name":42,"affiliation":43,"role":44},"Eiichi Watanabe, MD","Fujita University Bandane Hospital","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":18,"email":50},"Ranae Hoeft","CONTACT","(224) 543-4243","ranae.hoeft@irhythmtech.com",{"name":52,"role":48,"phone":18,"phoneExt":18,"email":53},"Chevy Brown","chevy.brown@irhythmtech.com",[55,74,87,103],{"facility":56,"status":18,"city":57,"state":18,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Gifu Heart Center","Gifu","5008384","Japan","JP",{"type":62,"coordinates":63},"Point",[64,65],136.76039,35.42291,{"lat":65,"lon":64},[68,72],{"name":69,"role":48,"phone":70,"phoneExt":18,"email":71},"Taiji Miyake, Physician","058-213-0489","miyake@heart-center.or.jp",{"name":73,"role":44,"phone":18,"phoneExt":18,"email":18},"Taiji Maiyake, cardiology",{"facility":75,"status":18,"city":57,"state":18,"zip":76,"country":59,"countryCode":60,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Ogaki City Hospital","5038502",{"type":62,"coordinates":78},[64,65],{"lat":65,"lon":64},[81,85],{"name":82,"role":48,"phone":83,"phoneExt":18,"email":84},"Itsuro Morishima, Physician","0584-81-3341","morishima-i@muc.biglobe.ne.jp",{"name":86,"role":44,"phone":18,"phoneExt":18,"email":18},"Itsuro Morishima, Cardiology",{"facility":88,"status":18,"city":89,"state":18,"zip":90,"country":59,"countryCode":60,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Fujita Health University Bantane Hospital","Nagoya","4548509",{"type":62,"coordinates":92},[93,94],136.90641,35.18147,{"lat":94,"lon":93},[97,101],{"name":98,"role":48,"phone":99,"phoneExt":18,"email":100},"Eiichi Watanabe, Physician","052-321-8171","enwatan@fujita-hu.ac.jp",{"name":102,"role":44,"phone":18,"phoneExt":18,"email":18},"Eiichi Watanabe, Cardiology",{"facility":104,"status":18,"city":89,"state":18,"zip":105,"country":59,"countryCode":60,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Nagoya Heart Center","4610045",{"type":62,"coordinates":107},[93,94],{"lat":94,"lon":93},[110,114],{"name":111,"role":48,"phone":112,"phoneExt":18,"email":113},"Koyo Sato, Physician","052-719-0810","ksatoh425@gmail.com",{"name":115,"role":44,"phone":18,"phoneExt":18,"email":18},"Koyo Sato, cardiology",{"type":117,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[119],{"name":120,"class":6},"A2 Healthcare Taiwan Corporation","100659960","head-to-head-h2h-comparison-of-ambulatory-cardiac-ecg-monitors-in-japan-100659960",false,"NCT07870837","Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan","Head-to-Head Comparison of Ambulatory Cardiac ECG Monitors in Japan","Japan H2H","Inclusion Criteria:\n\n1. Participant is 18 years of age and older\n2. Participant has reported symptoms that would prompt ambulatory ECG monitoring (i.e. palpitations, dizziness or lightheadedness, syncope or presyncope, shortness of breath, or asymptomatic)\n3. Participant is prescribed Heartnote device as part of clinical care\n4. Participant is willing and able to provide informed consent and able to complete all visits for this study\n\nExclusion Criteria:\n\n1. Participant has known permanent or persistent (i.e., 100% burden) atrial fibrillation (AF)\n2. Participants in whom inpatient monitoring should be prescribed.\n3. Participant has a known allergy to adhesives.\n4. Participant has a current skin infection or injury at location for study device placement.\n5. 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.\n6. Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.\n7. Participant with implantable cardiac defibrillator, pacemaker, or implantable loop recorders.\n8. Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.\n9. Participant is a member of a vulnerable population.\n10. Participant is a current or prior employee of iRhythm.\n11. 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\u002For follow-up visits.\n12. Participant does not have the competency to wear the device for the prescribed monitoring period.\n13. Participant does not have the ability to consent for themselves (i.e., no LARs)\n14. Participant is unable or unwilling to participate or comply with study protocol.","ALL","18 Years",{"count":132,"type":133},130,"ESTIMATED","INTERVENTIONAL",[20],"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.",[138,139,140,141,142,143,144,145,146,147,148,149,150,151],"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",[153,154,59,155,156,157,158,159,160,161,162,163,164,165,166,167,168],"ECG Monitor Comparison","ECG Monitor","Zio Monitor","Heartnote","ECG Monitoring","palpitations","dizziness","lightheadedness","syncope","presyncope","shortness of breath","asymptomatic cardiac","cardiac","device","ECG device","Cardiac Device","NOT_YET_RECRUITING","2026-10-06",{"date":172,"type":173},"2026-10-13","ACTUAL",{"date":175,"type":133},"2026-09-30",{"date":177,"type":133},"2027-12-31",{"name":5,"class":6},4]