[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Closed Joint-Stock Company NeoCor\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100518023","the-study-on-the-use-of-uniline-bioprosthesis-in-the-treatment-of-isolated-aortic-and-mitral-valve-diseases-100518023",false,"NCT06025149","The Study on the Use of \"UniLine\" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases","Open, Prospective, Multicenter Study of the Safety and Efficacy of \"UniLine\" Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases","Uniline","Inclusion Criteria:\n\n1. Provided informed consent to participate in the study.\n2. Must be aged 18 years and older.\n3. Patients with isolated acquired mitral or aortic valve disease.\n4. No prior heart valve replacement, current replacement must be planned (not conducted in an urgent\u002F emergency manner), using the \"UniLine\" biological prosthesis made from xenopericardium.\n5. Patient must be able to visit the Research Center.\n\nExclusion Criteria:\n\n1. Mechanical or biological prosthesis in another position. Patients with tricuspid valve repair may be included in the study.\n2. Prior heart valve replacement.\n3. Concomitant interventions on the heart (coronary artery bypass grafting, coronary heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and thoracic aorta.\n4. Patients with cancer in history.\n5. Patients with musculoskeletal conditions with severe movement disorders and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).\n6. Acute or subacute stages of infective endocarditis.\n7. Class IV heart failure according to the New York Heart Association Functional Classification with ongoing therapy, left ventricular ejection fraction less than 40%, myocardial infarction less than 90 days old, angina pectoris grade 4.\n8. The presence of severe somatic, neurological, mental and infectious diseases that worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular Filtration Rate less than 30 mL\u002F min \u002F 1.73 m²), chronic lung diseases requiring constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%, prior and planned interventions on the abdominal aorta, carotid arteries or arteries of the lower extremities).","ALL","18 Years","80 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic\u002Fmitral valve replacement using the \"UniLine\" bioprosthesis in patients with acquired aortic or mitral valve diseases.\n\nMain research objectives:\n\nTo analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the \"UniLine\" bioprosthesis.\n\nTo study the hemodynamic characteristics of normally functioning \"UniLine \" prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data.\n\nTo assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment.\n\nTo analyze the frequency of major serious adverse events associated with the \"UniLine\" bioprosthesis or procedure.",[26,27],"Aortic Valve Disease","Mitral Valve Disease",[29,30,31,32],"UniLine biological prosthesis","Acquired valve disease","Acquired aortic valve disease","Acquired mitral valve disease","RECRUITING","2024-09-24",{"date":36,"type":37},"2024-09-25","ACTUAL",{"date":39,"type":37},"2018-09-01",{"date":41,"type":22},"2035-01-31",{"name":43,"class":44},"Closed Joint-Stock Company NeoCor","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":45},"100515990","post-market-clinical-monitoring-of-the-safety-and-efficacy-of-the-aortic-valve-bioprothesis-100515990","NCT05998694","Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis","Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis \"ТiAra\" (T-ara)","TiAra","Inclusion Criteria:\n\n1. The patient's written consent to participate in the study and the absence of restrictions on physical movement (diseases of the musculoskeletal system and diseases of the central nervous system, accompanied by cognitive disorders (disorientation, inability to independently reach the destination).\n2. The patient is a resident of the city\\* (suburb) where the institution is conducting study.\n\n   \\* - participation is also possible for those living in the rural areas, but they have to be able to make visits to the Research Center.\n3. Age: 60-70 years old with a life expectancy of 3 years or more. Or a person younger than 60 with contraindications to taking anticoagulants, or with increased risk of their use, consciously choosing a biological prosthesis for valve replacement.\n4. Isolated aortic valve disease.\n5. Real intervention on the heart valve is primary.\n6. Absence of concomitant interventions on the heart and thoracic aorta\\*\\*.\n\n   \\*\\* - Coronary artery bypass grafting, correction of tricuspid valve disease, previously treated congenital heart defects, aortic intervention\n7. The intervention on the valve is planned (that is, it is not carried out in expedited\u002Furgent manner or is not a \"rescue\" operation).\n8. Absence of acute and subacute infective endocarditis.\n9. The following factors should not be present before surgery: high pulmonary hypertension (pulmonary arterial systolic pressure more than 60 mmHg), functional class 4 (according to the New York Heart Association Functional Classification) while in ongoing treatment, left ventricular ejection fraction less than 30%.\n\nExclusion Criteria:\n\n1. The presence of severe somatic, neurological, mental diseases and infectious diseases that worsen the prognosis of long-term survival (ischemic heart disease, tuberculosis, human immunodeficiency viruses, Alzheimer's disease, epilepsy, insulin-requiring diabetes, kidney disease with creatinine clearance less than 85 mL\u002Fmin, chronic lung disease requiring chronic corticosteroids and bronchodilators, multifocal atherosclerosis (intermittent claudication, carotid arteries stenosis of more than 50%, prior and planned interventions on abdominal area, carotid arteries or arteries of the lower extremities).\n2. The patient has any not related to the underlying cardiovascular system disease pathology that will lead to the death of the patient in less than 1 year.\n3. The patient is currently participating in a study of a new drug or other medical devices.","60 Years","70 Years",{"count":57,"type":22},2000,"The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the \"TiAra\" prosthesis with or without concomitant procedures.\n\nMain research objectives:\n\n1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the \"TiAra\" prosthesis.\n2. To study the hemodynamic characteristics of normally functioning \"TiAra\" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation.\n3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the \"TiAra\" prosthesis.\n\nThis study does not presuppose implementation of comparison groups.",[26,60],"Artificial Heart Valves",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"aortic valve","aortic valve bioprothesis TiAra","valve bioprosthesis","hemolysis","hemolytic anemia","a heart stroke","myocardial infarction","hemorrhaging and bleeding","heart arrhythmia","nonstructural dysfunction","pannus","prosthesis-patient mismatch","dislocation","paraprosthetic and transprosthetic regurgitation","heart failure","breast-pang","structural deterioration","valve thrombosis","thromboembolism","encarditis","a reoperation",{"date":36,"type":37},{"date":85,"type":37},"2021-06-01",{"date":87,"type":22},"2026-08-10",{"name":43,"class":44},{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":97,"conditions":98,"keywords":104,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":45},"100508060","study-on-efficacy-safety-and-durability-of-the-uniline-prosthesis-in-the-treatment-of-aortic-and-mitral-valve-disease-100508060","NCT05895487","Study on Efficacy, Safety and Durability of the UniLine Prosthesis in the Treatment of Aortic and Mitral Valve Disease","Multicentered Observational Cohort Study on the Efficacy, Safety and Durability of the \"UniLine\" Epoxy-treated Prosthesis Made With Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Disease (UniLine RetroFit)","Inclusion Criteria:\n\n* Patients of both sexes aged 18 years and older who underwent isolated mitral or aortic valve replacement using the \"UniLine\" bioprosthesis\n* No prior heart valve replacement\n\nExclusion Criteria:\n\n* The presence of a mechanical or biological prosthesis in another position\n* Prior valve repair\n* Aortic aneurysm repair (ascending aorta)\n* Resection of a left ventricular aneurysm\n* Patients with active cancer and patients with history of cancer",{"count":57,"type":22},"Acquired heart diseases continue to remain one of the most common causes of cardiac mortality and morbidity. In the Russian Federation, open surgery treatment of acquired valvular heart diseases (AVHD) is performed in more than 40 regions by specialists from 92 healthcare organizations.\n\nTreating aortic or mitral valve disease using the \"UniLine\" biological prosthesis is expected to improve survival rates. Supposedly, in vivo the \"UniLine\" biological prosthesis will show optimal hemodynamic characteristics and high resistance to structural valve degeneration and infectious damage, thus lowering the risk of dysfunction. Moreover, the risk of repeated intervention due to dysfunction of the \"UniLine\" bioprosthesis should not exceed the risk of the primary implantation. Supposedly, in the case of dysfunction of \"UniLine\" bioprosthesis it would be possible to perform repeated replacement using valve-in-valve technique.\n\nThe aim of the study is to assess the effectiveness, safety, durability of the \"UniLine\" epoxy-treated prosthesis and the long-term outcome of the treatment of isolated mitral and aortic valve diseases using this prosthesis.\n\nIn accordance with the objectives and hypothesis, the following data will be analyzed: actuarial and linear survival rates (general and cardiac), non-lethal prosthesis-associated complications, prosthetic dysfunction and repeated interventions.\n\nMoreover, in vivo hemodynamic parameters of the prosthesis will be assessed: the area of the effective opening surface, peak and mean gradient of pressure and blood flow velocity.\n\nThe study will be conducted at the Research Institute of Complex Issues of Cardiovascular Diseases. Study protocol received sponsorship approval and approval by Local Ethics Committee of the Research Institute and Research Coordinating Committee. The study will enroll patients who underwent isolated mitral or aortic valve replacement; transthoracic echocardiography will be conducted in all patients available for in-person visit.",[99,100,101,102,103],"Diseases of Mitral and Aortic Valves","Rheumatic Disorders of Mitral and Aortic Valves","Other Congenital Malformations of Aortic and Mitral Valves","Valvular Heart Disease (Aortic and Mitral Valves)","Mitral Valve Insufficiency and Aortic Valve Insufficiency",[105,106,62,107,108,109],"acquired heart diseases","mitral valve","prosthetic heart valves","bioprosthetic valves \"UniLine\"","bioprosthetic valve dysfunction",{"date":111,"type":37},"2024-09-26",{"date":113,"type":37},"2022-11-01",{"date":115,"type":22},"2026-05-01",{"name":43,"class":44},""]