Condition: Aortic Valve Disease · Artificial Heart Valves · Sponsor: Closed Joint-Stock Company NeoCor
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. Main research objectives: 1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis. 2. 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. 3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis. This study does not presuppose implementation of comparison groups.
This description comes directly from the study's public registry record.
Alexey Evtushenko, MD,PhD · +7 (3842) 64-33-08 · ave@kemcardio.ru
Denis Lebedev, MD · +79138456592 · mdlebedevd@mail.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/NCT05998694