[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100587626":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":32,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Corsano Health B.V.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients undergoing cardiac surgical intervention",null,"Patients ≥ 70 years of age who are scheduled to undergo aortic valve replacement, mitral valve repair with MitraClip, implantation of a pacemaker or percutaneous coronary intervention (PCI) at the Reinier de Graaf Gasthuis Cardiology department.",[13],"Device: Corsano CardioWatch 287-2",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Corsano CardioWatch 287-2","Eligible patients are asked to wear the Corsano CardioWatch 287-2 for 6 days, of which 3 days approximately 2 weeks before the procedure and 3 days approximately 2 months after the procedure.",[9],[21],{"name":22,"affiliation":23,"role":24},"Mariska van Vliet, MD, PhD","Reinier de Graaf Groep","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Eelko Ronner, MD, PhD","CONTACT","015-2603320","+31","eronner@rdgg.nl",[33],{"facility":34,"status":10,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Reinier de Graaf Gasthuis","Delft","South Holland","2625AD","Netherlands","NL",{"type":41,"coordinates":42},"Point",[43,44],4.35556,52.00667,{"lat":44,"lon":43},[47,49],{"name":27,"role":28,"phone":48,"phoneExt":30,"email":31},"015 - 260 33 20",{"name":22,"role":24,"phone":10,"phoneExt":10,"email":10},{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100587626","frailty-classification-algorithm-for-the-corsano-cardiowatch-287-2-a-development-and-validation-study-100587626",false,"NCT06930833","FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study","FRAILTY-CW2","Inclusion Criteria:\n\n* ≥ 70 years old\n* Be able to provide consent\n* Be scheduled to undergo one of the following procedures:\n\n  * Aortic valve replacement\n  * Mitral valve repair with MitraClip\n  * Implantation of a pacemaker\n  * Percutaneous coronary intervention (PCI)\n\nExclusion Criteria:\n\n* Unable to wear the Corsano CardioWatch 287-2 due to reasons such as allergic reactions, wounds, amputations etc.;\n* Unable or unwilling to sign informed consent;\n* Significant mental or cognitive impairment;\n* Cardiovascular disease where heart rate is not measurable (e.g. LVAD)","ALL","70 Years",{"count":62,"type":63},20,"ESTIMATED","OBSERVATIONAL","The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation.\n\nThe study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm.\n\nThe main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.",[67,68,69],"Cardiac Arrythmias","Valve Heart Disease","Cardiac Ischemia",[71,72,73,74,75,76,77],"Frailty","6-minute walking test","G8-score","wristband","wearable","remote monitoring","cardiac surgical interventions","NOT_YET_RECRUITING","2025-04-16",{"date":81,"type":82},"2025-04-20","ACTUAL",{"date":84,"type":63},"2025-05",{"date":86,"type":63},"2026-10",{"name":5,"class":6},1]