[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594377":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":60,"collaborators":62,"id":67,"slug":11,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":11,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":91,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"KARDI AI Technologies s.r.o.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Group with potential heart rythm disorder","EXPERIMENTAL",null,[13],"Device: Medical device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Medical device","Adding Kardi Ai medical device for detection of heart rythm disorders",[9],[21],{"name":22,"affiliation":23,"role":24},"Jiří Plášek, doc. MUDr. PhD. FESC","University Hospital Ostrava","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"David Skála","CONTACT","+420 779 998 100","david@kardi.ai",[32,48],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":36,"countryCode":11,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Fakultní nemocnice Olomouc","RECRUITING","Olomouc","Czechia","779 00",{"type":39,"coordinates":40},"Point",[41,42],17.25175,49.59552,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":29,"phoneExt":11,"email":47},"Jan Vácha, MUDr.","Jan.vacha@fnol.cz",{"facility":49,"status":34,"city":50,"state":36,"zip":51,"country":36,"countryCode":11,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"Fakultní nemocnice Ostrava","Ostrava","708 52",{"type":39,"coordinates":53},[54,55],18.28204,49.83465,{"lat":55,"lon":54},[58],{"name":22,"role":28,"phone":29,"phoneExt":11,"email":59},"jiri.plasek@fno.cz",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[63,65],{"name":33,"class":64},"UNKNOWN",{"name":23,"class":66},"OTHER","100594377",false,"NCT07018648","Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System","Clinical Safety and Efficacy Testing of a Medical Device Kardi Ai, an ECG Telemetry Monitoring System Using Artificial Intelligence to Evaluate ECGs Measured by Hardware Component (POLAR H10 Chest Strap)","Kardi Ai","Inclusion Criteria:\n\n* Age above 18 years\n* Signed informed consent\u002Fwillingness to cooperate\n* Confirmed or suspected heart rhythm disorder of a cardiac rhythm disorder\n* Ability to use a smartphone and mobile app Kardi Ai\n* The subject's mobile phone meets the minimum requirements for the Kardi Ai app to work\n\nExclusion Criteria:\n\n* Confirmed pregnancy\n* Allergic reactions to standard substances used in manufacture of clothing or other textiles\n* Superficial wound or skin irritation at the site of the chest belt attachment","ALL","18 Years",{"count":77,"type":78},115,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this clinical trial is to evaluate the safety and efficacy of medical device Kardi Ai, an ECG telemetry monitoring device in adult population.\n\nThe main questions it aims to answer are:\n\n* What is the sensitivity and specificity of Kardi Ai device for all monitored heart rythm disorders (combined)\n* What is the sensitivity and specificity of Kardi Ai device for each of the monitored heart rythm disorders\n* What is the quality of the ECG recordings\n\nParticipants will receive Kardi Ai medical device. They will use it to collect ECG recordings from at least 5 different days and in total collect records of at least 10 hours duration.",[84,85,86,87,88,89,90],"Atrial Fibrillation (AF)","Atrial Premature Complexes","Ventricular Premature Complexes","Bradycardia","Tachycardia","Supraventricular Tachycardia","Wide QRS Tachycardia",[92,93,94,95,96],"AI","heart rhythm disorders","ECG","EKG","atrial fibrillation","2025-06-10",{"date":99,"type":100},"2025-06-12","ACTUAL",{"date":102,"type":100},"2025-05-19",{"date":104,"type":78},"2025-08-30",{"name":5,"class":6},2]