[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100428829":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":48,"responsibleParty":68,"collaborators":42,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":42,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":42,"overallStatus":51,"whyStopped":42,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Nanjing First Hospital, Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical therapy","ACTIVE_COMPARATOR","Patients in medical therapy will receive conservative care, mainly including angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors\u002Fangiotensin receptor blockers (ARBs) or beta blockers.",[13],"Drug: Medical therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Transcatheter Aortic Valve Implantation","EXPERIMENTAL","Patients in TAVR group will receive transcatheter aortic valve replacement.",[19],"Device: Transcatheter Aortic Valve Implantation",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.",[15],[26],"The VitaFlow™ system (MicroPort®, Shanghai, China)",{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors\u002Fangiotensin receptor blockers (ARBs) or beta blockers.",[9],[32],"Optimal medical therapy",[34],{"name":35,"affiliation":5,"role":36},"Shao-Liang Chen, MD, PhD","STUDY_CHAIR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Jun-Jie Zhang, MD, PhD","CONTACT","+86-25-52271350",null,"jameszll@163.com",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Jing Kan, MPH","+86-25-52271398","kanjingok@126.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Nanjing First Hospital","RECRUITING","Nanjing","Jiangsu","210006","China","CN",{"type":58,"coordinates":59},"Point",[60,61],118.77778,32.06167,{"lat":61,"lon":60},[64],{"name":65,"role":40,"phone":66,"phoneExt":42,"email":67},"Shaoliang Chen, MD","+86 13605157029","chmengx@126.com",{"type":69,"investigatorFullName":65,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital","100428829","transcatheter-self-expandable-valve-implantation-for-the-treatment-of-severe-native-aortic-regurgitation-100428829",false,"NCT04864145","Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation","Transcatheter Self-expandable Valve Implantation for the Treatment of Severe Native Aortic Regurgitation: a Prospective, Multicenter, Randomized Study","SEASON-AR","Inclusion Criteria:\n\n1. Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \\> 65mm or left ventricular end-systolic dimension (LVESD) \\> 50mm;\n2. Severe aortic valve regurgitation, and mean pressure gradient \\\u003C 20mmHg; Annular perimeter ≤ 85 mm;\n3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05;\n4. STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement:\n\n   1. Severe aorta calcification or active ascending aorta atherosclerotic plaque\n   2. History of mediastinum radiotherapy\n   3. Past mediastinitis\n   4. Presence of unobstructed coronary bypass implants\n   5. Previous more than two cardiothoracic surgeries\n   6. Liver cirrhosis\n   7. Other surgical risk factors\n\nExclusion Criteria:\n\n1. Age \\\u003C 60 years old;\n2. Ascending aorta diameter \\>45mm;\n3. Coronary multi-vessel disease (SYNTAX score \\>32);\n4. Life expectancy \\\u003C1 year;\n5. Left ventricular ejection fraction \\\u003C30%;\n6. Acute myocardial infarction within 30 days;\n7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents);\n8. Other situations judged by the researcher as unsuitable for participating in the study.","ALL","60 Years","90 Years",{"count":83,"type":84},210,"ESTIMATED","INTERVENTIONAL",[87],"NA","Prospective, multicenter, randomized trial.",[90],"Aortic Valve Disease","2026-04-07",{"date":93,"type":94},"2026-04-08","ACTUAL",{"date":96,"type":94},"2021-05-21",{"date":98,"type":84},"2031-05-30",{"name":5,"class":6},1]