Condition: Diseases of Mitral and Aortic Valves · Rheumatic Disorders of Mitral and Aortic Valves · Other Congenital Malformations of Aortic and Mitral Valves · Sponsor: Closed Joint-Stock Company NeoCor
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. Treating 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. The 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. In 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. Moreover, in vivo hemodynamic parameters of the prosthesis will be assessed: the area of the effect…
This description comes directly from the study's public registry record.
Evgeny Bazdyrev · +7 (3842) 644240 · clinicresearch@kemcardio.ru
Michael Karelin · +7 (913) 433 7669 · karelin@ctmedical.ru
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| Federal State Budgetary Scientific Institution "Research Institute for Complex Issues of Cardiovascilar Diseases" | Kemerovo, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05895487