[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100417983":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":277,"collaborators":279,"id":310,"slug":311,"hasResults":312,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":42,"eligibilityCriteria":316,"healthyVolunteers":312,"sex":317,"minAge":318,"maxAge":42,"enrollmentInfo":319,"targetDuration":42,"studyType":322,"phases":323,"briefSummary":325,"conditions":326,"keywords":329,"overallStatus":148,"whyStopped":42,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAVR with Supra-annular sizing strategy","EXPERIMENTAL","Experimental: Supra-annular sizing strategy (Hangzhou Solution).\n\nPre-dilation with balloon size (20\u002F23\u002F26mm Z-MED) just below the annular size.\n\nWaist sign with less than mild contrast regurgitation: Venus A plus Valve down size and Target implant depth 0-2mm.\n\nNo waist sign and\u002For contrast regurgitation or unable to finish supra-annular sizing: annular sizing Venus A plus Valve with implant depth 4-6mm.",[13],"Device: TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)",{"label":15,"type":6,"description":16,"interventionNames":17},"TAVR with Annulus based sizing strategy","Control: Traditional sizing strategy (Annulus based sizing strategy).\n\nPre-dilation with balloon size (20\u002F23\u002F26mm Z-MED) just below the annular size.\n\nAnnular sizing Venus A plus Valve with implant depth 4-6mm.",[18],"Device: TAVR with Venus A plus using annular sizing and THV implantation technique",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)","Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)",[9],[26],"Hangzhou solution",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"TAVR with Venus A plus using annular sizing and THV implantation technique","Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)",[15],[32],"Traditional sizing strategy (Annulus based sizing strategy)",[34],{"name":35,"affiliation":36,"role":37},"Jian'an Wang, PhD, MD","2nd Affiliated Hospital, School of Medicine, Zhejiang University, China","STUDY_CHAIR",[39],{"name":35,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+86057187783777",null,"wja@zju.edu.cn",[45,62,74,88,100,113,127,136,146,161,174,188,202,211,225,238,251,264],{"facility":46,"status":47,"city":48,"state":49,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"The First affiliated hospital of bengbu medical college","NOT_YET_RECRUITING","Bengbu","Anhui","China","CN",{"type":53,"coordinates":54},"Point",[55,56],117.36083,32.94083,{"lat":56,"lon":55},[59],{"name":60,"role":40,"phone":42,"phoneExt":42,"email":61},"Shili Wu","chinawsl@126.com",{"facility":63,"status":47,"city":64,"state":65,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"The General Hospital of the People's Liberation Army","Beijing","Beijing Municipality",{"type":53,"coordinates":67},[68,69],116.39723,39.9075,{"lat":69,"lon":68},[72],{"name":73,"role":40,"phone":42,"phoneExt":42,"email":42},"Yundai Chen",{"facility":75,"status":47,"city":76,"state":77,"zip":78,"country":50,"countryCode":51,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Fujian Medical University Union Hospital","Fuzhou","Fujian","350001",{"type":53,"coordinates":80},[81,82],119.30611,26.06139,{"lat":82,"lon":81},[85],{"name":86,"role":40,"phone":42,"phoneExt":42,"email":87},"Lianglong Cheng","lianglongchen@126.com",{"facility":89,"status":47,"city":90,"state":77,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Xiamen University Affiliated Cardiovascular Hospital","Xiamen",{"type":53,"coordinates":92},[93,94],118.08187,24.47979,{"lat":94,"lon":93},[97],{"name":98,"role":40,"phone":42,"phoneExt":42,"email":99},"Yan Wang","wy@medmail.com.cn",{"facility":101,"status":47,"city":102,"state":103,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Guangdong People's Hospital","Guangzhou","Guangdong",{"type":53,"coordinates":105},[106,107],113.25,23.11667,{"lat":107,"lon":106},[110],{"name":111,"role":40,"phone":42,"phoneExt":42,"email":112},"Jianfang Luo","jianfangluo@sina.com",{"facility":114,"status":47,"city":115,"state":116,"zip":117,"country":50,"countryCode":51,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Zhengzhou Cardiovascular Hospital","Zhengzhou","Henan","450016",{"type":53,"coordinates":119},[120,121],113.64861,34.75778,{"lat":121,"lon":120},[124],{"name":125,"role":40,"phone":42,"phoneExt":42,"email":126},"Shenwei Zhang","zhangsw214@163.com",{"facility":128,"status":47,"city":115,"state":116,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":129,"geoPoint":131,"contacts":132},"The First Affiliated Hospital of Zhengzhou University",{"type":53,"coordinates":130},[120,121],{"lat":121,"lon":120},[133],{"name":134,"role":40,"phone":42,"phoneExt":42,"email":135},"Jianzeng Dong","jz_dong@126.com",{"facility":137,"status":47,"city":115,"state":138,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"Hennan Provincial Chest Hospital","Hennan",{"type":53,"coordinates":140},[120,121],{"lat":121,"lon":120},[143],{"name":144,"role":40,"phone":42,"phoneExt":42,"email":145},"Yiqiang Yuan","zzqyuanyiqiang@126.com",{"facility":147,"status":148,"city":149,"state":150,"zip":151,"country":50,"countryCode":51,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology","RECRUITING","Wuhan","Hubei","430022",{"type":53,"coordinates":153},[154,155],114.26667,30.58333,{"lat":155,"lon":154},[158],{"name":159,"role":40,"phone":42,"phoneExt":42,"email":160},"Xiaoke Shang","14236338@qq.com",{"facility":162,"status":47,"city":163,"state":164,"zip":42,"country":50,"countryCode":51,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"The Second XIANGYA Hospital Of Central South University","Changsha","Hunan",{"type":53,"coordinates":166},[167,168],112.97087,28.19874,{"lat":168,"lon":167},[171],{"name":172,"role":40,"phone":42,"phoneExt":42,"email":173},"Zhengfei Fang","fangzhenfei@csu.edu.cn",{"facility":175,"status":47,"city":176,"state":177,"zip":178,"country":50,"countryCode":51,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Northern Jiangsu People's Hospital","Yangzhou","Jiangsu","225001",{"type":53,"coordinates":180},[181,182],119.43583,32.39722,{"lat":182,"lon":181},[185],{"name":186,"role":40,"phone":42,"phoneExt":42,"email":187},"Shenghu He","yzhshys@163.com",{"facility":189,"status":47,"city":190,"state":191,"zip":192,"country":50,"countryCode":51,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330006",{"type":53,"coordinates":194},[195,196],115.85306,28.68396,{"lat":196,"lon":195},[199],{"name":200,"role":40,"phone":42,"phoneExt":42,"email":201},"Xiaoping Peng","cdyfypxp@163.com",{"facility":203,"status":47,"city":190,"state":191,"zip":192,"country":50,"countryCode":51,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"The Second Affiliated Hospital of Nanchang University",{"type":53,"coordinates":205},[195,196],{"lat":196,"lon":195},[208],{"name":209,"role":40,"phone":42,"phoneExt":42,"email":210},"Yanqing Wu","wuyanqing01@sina.com",{"facility":212,"status":47,"city":213,"state":214,"zip":215,"country":50,"countryCode":51,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"The Affiliated Hospital of Qingdao University","Qingdao","Shandong","266000",{"type":53,"coordinates":217},[218,219],120.38042,36.06488,{"lat":219,"lon":218},[222],{"name":223,"role":40,"phone":42,"phoneExt":42,"email":224},"Lei Jiang","anjianer@126.com",{"facility":226,"status":47,"city":227,"state":228,"zip":229,"country":50,"countryCode":51,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Shanxi Cardiovascular Hospital","Taiyuan","Shanxi","030024",{"type":53,"coordinates":231},[232,233],112.56028,37.86944,{"lat":233,"lon":232},[236],{"name":237,"role":40,"phone":42,"phoneExt":42,"email":224},"Jian An",{"facility":239,"status":47,"city":240,"state":240,"zip":241,"country":50,"countryCode":51,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"tianjin Chest Hospital","Tianjing","300222",{"type":53,"coordinates":243},[244,245],120.77196,31.46583,{"lat":245,"lon":244},[248],{"name":249,"role":40,"phone":42,"phoneExt":42,"email":250},"Nan Jiang","tjxkcs2@163.com",{"facility":252,"status":148,"city":253,"state":254,"zip":255,"country":50,"countryCode":51,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"The Second Affiliated Hospital Zhejiang University School of Medicine.","Hangzhou","Zhejiang","310006",{"type":53,"coordinates":257},[258,259],120.16142,30.29365,{"lat":259,"lon":258},[262],{"name":263,"role":40,"phone":42,"phoneExt":42,"email":43},"Jian'an Wang, MD",{"facility":265,"status":148,"city":266,"state":254,"zip":267,"country":50,"countryCode":51,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Ning Bo First Hospital","Ningbo","315010",{"type":53,"coordinates":269},[270,271],121.54945,29.87819,{"lat":271,"lon":270},[274],{"name":275,"role":40,"phone":42,"phoneExt":42,"email":276},"Xiaomin Cheng","chxmin@hotmail.com",{"type":278,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[280,283,285,287,288,290,292,294,295,297,299,301,302,303,305,306,307,309],{"name":281,"class":282},"Venus MedTech (HangZhou) Inc.","INDUSTRY",{"name":284,"class":6},"The First Affiliated Hospital of Bengbu Medical University",{"name":286,"class":6},"Chinese PLA General Hospital",{"name":75,"class":6},{"name":89,"class":289},"UNKNOWN",{"name":291,"class":6},"The Second People's Hospital of GuangDong Province",{"name":293,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital",{"name":128,"class":6},{"name":296,"class":6},"Henan Provincial Chest Hospital",{"name":298,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":300,"class":6},"Central South University",{"name":175,"class":6},{"name":189,"class":6},{"name":304,"class":6},"Second Affiliated Hospital of Nanchang University",{"name":212,"class":6},{"name":226,"class":6},{"name":308,"class":6},"Tianjin Chest Hospital",{"name":265,"class":289},"100417983","hangzhou-solution-in-bicuspid-as-undergoing-tavr-100417983",false,"NCT04722796","HANGZHOU Solution in Bicuspid AS Undergoing TAVR","HANGZHOU Solution for Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement by Using Supra-annular Structure Based Balloon Sizing Strategy","Inclusion Criteria:\n\n* Age ≥ 65 years\n* Age \\\u003C65 years and age ≥ 60 years with high surgical risk after combing STS Risk Estimate, Katz activities of Daily Living, major Organ System Dysfunction and Procedure-Specific Impediment;\n* Severe, bicuspid aortic stenosis:\n* Mean gradient ≥40 mmHg\n* Maximal aortic valve velocity ≥4.0 m\u002Fsec\n* Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2\u002Fm2)\n* NYHA classification ≥ II;\n* Type 0, type 1 (Sievers classification) by MDCT\n* Perimeter-derived annulus diameter ranges from 20.0 mm to 29.0 mm;\n* Transfemoral TAVR\n* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FEthics Committee (EC) of the respective clinical site.\n\nExclusion Criteria:\n\n* Any contra-indication for Self-expanding bioprosthetic aortic valve deployment\n* Leukopenia (WBC \\\u003C 3000 cell\u002FmL), acute anemia (Hgb \\\u003C 9 g\u002FdL), Thrombocytopenia (Plt\\\u003C 50,000 cell\u002FmL).\n* Active sepsis, including active bacterial endocarditis with or without treatment;\n* Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment \\[(defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and\u002For troponin level elevation (WHO definition)\\].\n* Stroke or transient ischemic attack (TIA) within 3 months (90 days) of the procedure.\n* Estimated life expectancy \\\u003C 12 months (365 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease.\n* Any Emergent surgery required before TAVR procedure.\n* A known hypersensitivity or contraindication to any of the following that cannot be adequately medicated:aspirin or heparin (HIT\u002FHITTS) and bivalirudin, clopidogrel,Nitinol (titanium or nickel),contrast media\n* Gastrointestinal (GI) bleeding that would preclude anticoagulation.\n* Subject refuses a blood transfusion.\n* Severe dementia (resulting in either inability to provide informed consent for the study\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits).\n* Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams.\n* Currently participating in an investigational drug or another device study (excluding registries).\n* Hypertrophic cardiomyopathy (HCM with myocardium more than 1.5cm without an identifiable cause) with obstruction (HOCM).\n* Echocardiographic evidence of intracardiac mass, thrombus or vegetation.\n* Severe mitral stenosis amenable to surgical replacement or repair.\n* Aortic valve type cannot be determined (Sievers classification).\n* Significant aortic disease, including marked tortuosity (hyperacute bend), aortic arch atheroma \\[especially if thick (\\> 5 mm), protruding or ulcerated\\] or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe\"unfolding\" and horizontal aorta(Annular Angulation\\>70°).\n* Ascending aorta diameter \\> 50 mm.\n* Aortic or iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.\n* Patient is considered high risk for TAVR by CT corelab, including coronary obstruction, annular rupture and other severe TAVR-Related complications.\n* Previous pacemaker implantation.","ALL","60 Years",{"count":320,"type":321},508,"ESTIMATED","INTERVENTIONAL",[324],"NA","To compare supra-annular sizing and THV implantation technique (Hangzhou solution) versus annular sizing and THV implantation technique (control group) in bicuspid aortic stenosis (AS) patients undergoing transcatheter aortic valve replacement (TAVR) with self-expanding valves (SEVs): a randomized superiority trial",[327,328],"Aortic Stenosis","Aortic Stenosis With Bicuspid Valve",[330,331,332],"Transcatheter aortic valve replacement","Aortic Stenosis with Bicuspid Valve","supra-annular sizing","2021-05-28",{"date":335,"type":336},"2021-06-02","ACTUAL",{"date":338,"type":336},"2021-04-12",{"date":340,"type":321},"2028-04-01",{"name":5,"class":6},18]