[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100397365":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":34,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SMART watch",null,"Medical records from patients aged 18 years or older undergoing Transcatheter Aortic Valve Replacement",[13],"Device: HUAWEI watch",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","HUAWEI watch","HUAWEI Watch will be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P waves after triggering.",[9],[21],{"name":22,"affiliation":5,"role":23},"Jian-an Wang, MD, PhD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Jiaqi Fan, MD","CONTACT","+86-15267029492","fanjiaqi@zju.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Xianbao Liu, MD, PhD","+86-13857173887","liuxb2009@hotmail.com",[35],{"facility":5,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.16142,30.29365,{"lat":46,"lon":45},[49,50,51],{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":22,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100397365","smart-watch-facilitated-early-discharge-in-patients-undergoing-transcatheter-aortic-valve-replacement-100397365",false,"NCT04454177","SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement","SMART TAVR: SMART Watch Facilitated Early Discharge in Patients Undergoing Transcatheter Aortic Valve Replacement","SMART TAVR","Inclusion Criteria:\n\n* At least 18 years old;\n* Be willing and able to provide informed consent to participate in the study;\n* Not share HUAWEI Watch, HUAWEI phone with anyone else;\n* Patient has severe aortic stenosis with echocardiographically derived criteria: mean gradient \\> 40mmHg or maximum velocity greater than 4.0 m\u002Fs or an initial aortic valve area of \\\u003C 1.0 cm2;\n* Patient who undergoing elective transfemoral transcatheter aortic valve replacement.\n\nExclusion Criteria:\n\n* Severe complications of TAVR, such as death, and conversion to SAVR;\n* Life expectancy is less than 12 months due to non-heart disease (such as cancer, chronic liver disease, chronic kidney disease, or chronic end-stage lung disease, etc.);\n* Severe dementia (cannot sign research informed consent, cannot take care of themselves or complete the study visit);\n* The investigator believes that the patient is not suitable to participate in the study or complete the follow-up prescribed by the protocol from other medical, social and psychological aspects;\n* The patient is currently participating in another randomized study.","ALL","18 Years",{"count":65,"type":66},100,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to observe conduction disturbance, daily activity level, heart rates, oxygen saturation in patients who underwent Transcatheter Aortic Valve Replacement (TAVR) and to evaluate the utility of the HUAWEI Watch (HUAWEI Technologies Co., Ltd., Shenzhen, China) for the potential early warning sign of changes in multiple biometric parameters including heart rate, rhythm, oxygen saturation, activity, and sleep in patients following TAVR. This will be evaluated in the context of a recently implemented early discharge protocol.",[70,71,72],"Aortic Stenosis","Valvular Heart Disease","Transcatheter Aortic Valve Replacement","2020-10-25",{"date":75,"type":76},"2020-10-27","ACTUAL",{"date":78,"type":76},"2020-07-15",{"date":80,"type":66},"2031-07-01",{"name":5,"class":6},1]