[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment","EXPERIMENTAL","Transcatheter atrioventricular valve replacement with the Prizvalve® system",[13],"Device: Prizvalve® system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Prizvalve® system","Transcatheter atrioventricular valve replacement",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Zhongshan Hospital","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":31,"coordinates":32},"Point",[33,34],121.45806,31.22222,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Wang chunsheng, Chief","CONTACT","(86)021-64041990","2512","cswang@medmail.com.cn",{"type":44,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[46],{"name":47,"class":48},"Shanghai Zhongshan Hospital","OTHER","100460397","prizvalve-transcatheter-atrioventricular-valve-replacement-study-100460397",false,"NCT05275088","Prizvalve® Transcatheter Atrioventricular Valve Replacement Study","An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair","1\\. Inclusion criteria for patients with severe atrioventricular valve annular calcification:\n\n1. Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);\n2. Patient with symptoms, and NYHA Functional Class≥Ⅱ;\n3. 18 years and older who is not in pregnancy or lactation;\n4. Life expectancy\\>12 months;\n5. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;\n6. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;\n7. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;\n8. Patient with high risk of routine surgery (STS\\>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated.\n\n2\\. Inclusion criteria for patients with failed prosthetic atrioventricular valve\u002Fannulus repair:\n\n1. The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;\n2. The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination);\n3. 18 years and older who is not in pregnancy or lactation;\n4. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;\n5. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;\n6. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;\n7. Patient with high risk of routine surgery (STS\\>8%) or severe comorbidities that is not suitable for surgery.\n\nExclusion criteria:\n\n1. Evidence of an acute myocardial infarction \\\u003C1 month(30 days) before the intended treatment;\n2. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;\n3. Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;\n4. Patient with hypertrophic cardiomyopathy with obstruction;\n5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \\\u003C20%;\n6. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n7. Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;\n8. Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;\n9. Active stage of infective endocarditis or other active infection;\n10. Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;\n11. Patient with poor compliance and could not complete the study as required.","ALL","18 Years",{"count":59,"type":60},15,"ESTIMATED","INTERVENTIONAL",[63],"NA","To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve\u002F annulus repair.",[66,67],"Atrioventricular Annular Calcification","Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair","2023-11-14",{"date":70,"type":71},"2023-11-18","ACTUAL",{"date":73,"type":71},"2022-03-09",{"date":75,"type":60},"2028-06-10",{"name":5,"class":6},1]