[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460397":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":31,"studyPopulation":24,"armGroups":32,"interventions":39,"overallOfficials":24,"centralContacts":24,"locations":45,"responsibleParty":67,"collaborators":69,"id":73,"slug":24,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":24,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":24,"enrollmentInfo":81,"targetDuration":24,"studyType":84,"phases":85,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Technical success","Definition:\n\n1. Freedom from death;\n2. Successful vascular delivery and retrieval of transcatheter valve delivery system;\n3. Correct position of transcatheter valve;\n4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related);\n5. Adequate performance of prosthesis (mean pressure gradient (MVG) \\\u003C10mmHg, valve regurgitation \\\u003C2+).","30 days",[14,18,21],{"measure":15,"description":16,"timeFrame":17},"Procedural Success","1. Device success;\n2. No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs\u002For cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.","30 days,1 year",{"measure":19,"description":20,"timeFrame":17},"Device success","Definitions:\n\n1. Freedom from stroke;\n2. Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis);\n3. No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related);\n4. No atrioventricular valve stenosis (mean pressure gradient \\\u003C10mmHg);\n5. Atrioventricular valve regurgitation \\\u003C2+ (including central leakage and paravalvular leakage), and no related hemolysis;\n6. LVOT pressure gradient increased \\\u003C20mmHg.",{"measure":22,"description":23,"timeFrame":17},"All-cause mortality","All-cause mortality included cardiac and non-cardiac death.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":24,"primaryPurpose":28,"observationalModel":24,"timePerspective":24,"maskingInfo":29},"NA","SINGLE_GROUP","TREATMENT",{"masking":30,"maskingDescription":24,"whoMasked":24},"NONE","The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Treatment","EXPERIMENTAL","Transcatheter atrioventricular valve replacement with the Prizvalve® system",[38],"Device: Prizvalve® system",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":24},"DEVICE","Prizvalve® system","Transcatheter atrioventricular valve replacement",[34],[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Zhongshan Hospital","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Wang chunsheng, Chief","CONTACT","(86)021-64041990","2512","cswang@medmail.com.cn",{"type":68,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[70],{"name":71,"class":72},"Shanghai Zhongshan Hospital","OTHER","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":82,"type":83},15,"ESTIMATED","INTERVENTIONAL",[26],"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.",[88,89],"Atrioventricular Annular Calcification","Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair","2023-11-14",{"date":92,"type":93},"2023-11-18","ACTUAL",{"date":95,"type":93},"2022-03-09",{"date":97,"type":83},"2028-06-10",{"name":5,"class":6},1]