[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396438":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":54,"collaborators":19,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":19,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":19,"enrollmentInfo":65,"targetDuration":19,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":19,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Tomsk National Research Medical Center of the Russian Academy of Sciences","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"bioprosthesis","EXPERIMENTAL","prosthetics of heart valves with dentures \"MedEng-Bio\"",[13],"Procedure: valve prosthetics",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"PROCEDURE","valve prosthetics",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Boris N. Kozlov, MD","PRINCIPAL_INVESTIGATOR",[25,29],{"name":26,"role":27,"phone":19,"phoneExt":19,"email":28},"Elena B. Kim","CONTACT","ekim@cardio-tomsk.ru",{"name":30,"role":27,"phone":31,"phoneExt":19,"email":32},"Konstantin A. Petlin, PhD","+79138259164","kpetlin@yandex.ru",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Tomsk","Tomsk Oblast","634012","Russia","RU",{"type":42,"coordinates":43},"Point",[44,45],84.98216,56.50049,{"lat":45,"lon":44},[48,49,51],{"name":26,"role":27,"phone":19,"phoneExt":19,"email":28},{"name":50,"role":23,"phone":19,"phoneExt":19,"email":19},"Boris N Kozlov, MD",{"name":52,"role":53,"phone":19,"phoneExt":19,"email":19},"Konstantin A Petlin, PhD","SUB_INVESTIGATOR",{"type":23,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Boris N. Kozlov","Professor","100396438","the-study-of-biological-prosthetic-heart-valves-with-the-easy-change-system-100396438",false,"NCT04442100","The Study of Biological Prosthetic Heart Valves With the \"Easy Change\" System","Inclusion Criteria:\n\n1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 \u002F m2, average gradient more than 40 mm RT. Art;\n\n   o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 \u002F m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)\n2. mitral valve disease requiring surgical disease\n\nExclusion Criteria:\n\n1. the need for prosthetics of two or more valves\n2. patients with a decrease in LVEF of less than 45%;\n3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death\n4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);\n5. the diameter of the ascending aorta is more than 45 mm;\n6. unwillingness of the patient to participate in the study.","ALL","60 Years",{"count":66,"type":67},500,"ESTIMATED","INTERVENTIONAL",[70],"NA","The study of new biological heart valves with the \"easy change\" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality",[73],"Heart Valve Diseases","2026-06-25",{"date":76,"type":77},"2026-06-26","ACTUAL",{"date":79,"type":77},"2016-11-29",{"date":81,"type":67},"2026-12-31",{"name":5,"class":6},1]