[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505674":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":33,"locations":41,"responsibleParty":55,"collaborators":57,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":20,"enrollmentInfo":72,"targetDuration":20,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":20,"overallStatus":43,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shanghai NewMed Medical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcatheter aortic valve replacement","EXPERIMENTAL","Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system",[13],"Device: Prizvalve Pro™ transcatheter aortic valve system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Prizvalve Pro™ transcatheter aortic valve system","Transcatheter Aortic Valve Replacement",[9],null,[22,26,30],{"name":23,"affiliation":24,"role":25},"Yaling Han, Professor","Principal coordinating investigator","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"Mao Chen, Professor","coordinating investigator","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":28,"role":32},"Kai Xu, Professor","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":20,"email":38},"Chunyang Wang","CONTACT","(86)-21-20788668","wang_chunyang@newmed.cn",{"name":40,"role":36,"phone":37,"phoneExt":20,"email":20},"Xuyang Xie",[42],{"facility":5,"status":43,"city":44,"state":20,"zip":20,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Shanghai","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":40,"role":36,"phone":20,"phoneExt":20,"email":20},{"type":56,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[58,61],{"name":59,"class":60},"The General Hospital of Northern Theater Command","OTHER",{"name":62,"class":60},"West China Hospital","100505674","prizvalve-pro-transcatheter-aortic-valve-replacement-study-100505674",false,"NCT05864456","Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study","Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk","Inclusion Criteria:\n\n1. Age ≥ 65 years ;\n2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m\u002Fs, or aortic Valve area\\\u003C1.0cm², or AVA \\\u003C0.5cm² \u002Fm²);\n3. Cardiac function NYHA ≥ II;\n4. Life expectancy\\> 12 months;\n5. Patients who are anatomically suitable for transcatheter aortic valve implantation;\n6. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;\n7. Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.\n\nExclusion Criteria:\n\n1. Acute myocardial infarction occurred within 1 month before this treatment;\n2. Congenital unicuspid aortic valve;\n3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);\n4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\\>3+);\n5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;\n6. Untreated severe coronary artery stenosis that requires revascularization;\n7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;\n8. Patients who need emergency surgery for any reason;\n9. Patients with hypertrophic cardiomyopathy with obstruction;\n10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \\\u003C20%;\n11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;\n12. Patients with left ventricular outflow tract obstruction;\n13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;\n14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;\n15. Patients who are unable to receive anticoagulation or antiplatelet therapy;\n16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;\n17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;\n18. Active infective endocarditis or other active infections;\n19. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;\n20. The investigator judged that patient with poor compliance and could not complete the study as required.","ALL","65 Years",{"count":73,"type":74},73,"ESTIMATED","INTERVENTIONAL",[77],"NA","The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.",[80],"Aortic Valve Stenosis","2023-11-14",{"date":83,"type":84},"2023-11-18","ACTUAL",{"date":86,"type":84},"2023-07-05",{"date":88,"type":74},"2028-05",{"name":5,"class":6},1]