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Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis
Sponsor: Closed Joint-Stock Company NeoCor
Summary
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.
Official title: Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis "ТiAra" (T-ara)
Key Details
Gender
All
Age Range
60 Years - 70 Years
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2021-06-01
Completion Date
2026-08-10
Last Updated
2024-09-25
Healthy Volunteers
No
Locations (1)
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, Russia