Condition: Aortic Valve Disease · Mitral Valve Disease · Sponsor: Closed Joint-Stock Company NeoCor
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases. Main research objectives: To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis. To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data. To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment. To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.
This description comes directly from the study's public registry record.
Evgeny Bazdyrev, MD, PhD · +7-3842-64-42-40 · clinicresearch@kemcardio.ru
Michael Karelin · 8 (913) 433 7669 · karelin@ctmedical.ru
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| Research Institute for Complex Problems of Cardiovascular Diseases, Russia | Kemerovo, Kemerovo Oblast, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06025149