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The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Sponsor: Closed Joint-Stock Company NeoCor
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2018-09-01
Completion Date
2035-01-31
Last Updated
2024-09-25
Healthy Volunteers
No
Conditions
Locations (1)
Research Institute for Complex Problems of Cardiovascular Diseases, Russia
Kemerovo, Kemerovo Oblast, Russia