[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100381764":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":10,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":10,"maxAge":10,"enrollmentInfo":55,"targetDuration":58,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Philips Clinical & Medical Affairs Global","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Suspected Sudden Cardiac Arrest",null,"All subject with suspected of a circulatory arrest for any cause.",[13],"Device: HeartStart FRX",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","HeartStart FRX","Automated External Defibrillator",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Barb Fink","CONTACT","724-708-7048","barb.fink@philips.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Philips","RECRUITING","Monroeville","Pennsylvania","15146","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-79.7881,40.42118,{"lat":39,"lon":38},[42,43],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},"Gerrit Noordergraaf, MD","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100381764","heartstart-frx-defibrillator-event-registry-100381764",false,"NCT04250857","HeartStart FRx Defibrillator Event Registry","Inclusion Criteria:\n\n* Subjects accepted into the study must: have been suspected of a circulatory arrest for any cause\n* Have had HeartStart FRx AED with electrodes: HeartStart SMART PADS II applied to their body and powered up, regardless of whether a defibrillation shock was delivered\n\nExclusion Criteria:\n\n* AED or pad use other than the HeartStart FRx AED with electrodes : HeartStart SMART PADS II\n* AED used for training purposes.","ALL",{"count":56,"type":57},1400,"ESTIMATED","1 Day","OBSERVATIONAL","This post market clinical follow-up study is a multi-center, non-randomized, unblinded, observational registry of the performance of the FRx Automated external defibrillator (AED) used in conjunction with electrodes with or without use of the infant\u002Fchild key. The registry is focused only on on post-event data collection and does not prescribe any device usage. This registry has several safeguards in place to prevent against selections bias, including enrollment of all participants who have pads placed. This registry will evaluate the safety and verify the clinical performance of the device in relation to its claims, when used in accordance with the Device Manual.",[62],"Sudden Cardiac Arrest","2025-02-25",{"date":65,"type":66},"2025-02-26","ACTUAL",{"date":68,"type":66},"2019-11-04",{"date":70,"type":57},"2027-12",{"name":5,"class":6},1]