[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"failed-prosthetic-atrioventricular-valve-annulus-repair\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:failed-prosthetic-atrioventricular-valve-annulus-repair":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Atrioventricular Annular Calcification","Failed Prosthetic Atrioventricular Valve\u002F Annulus Repair","RECRUITING","2023-11-14",{"date":31,"type":32},"2023-11-18","ACTUAL",{"date":34,"type":32},"2022-03-09",{"date":36,"type":20},"2028-06-10",{"name":38,"class":39},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY"]