OPEN PROSPECTIVE MULTICENTER STUDY OF THE SAFETY AND EFFICACY OF THE “UNILINE” EPOXY-TREATED PROSTHESIS MADE FROM XENOPERICARDIUM IN THE TREATMENT OF ISOLATED AORTIC AND MITRAL VALVE DISEASES (UNILINE): RATIONALE, OBJECTIVES AND DESIGN OF THE STUDY

Highlights

• The “UniLine” study is a major domestic prospective, multicenter medical device investigation focusing on devices used in the surgery of valvular heart disease. This study is designed to provide a comprehensive assessment of the safety and efficacy of the domestic epoxy-treated xenopericardial prosthesis “UniLine” for treating isolated aortic and mitral valve defects, based on the long-term results of the use of this bioprosthesis in real clinical practice.

Abstract

The number of valve replacements using biological prostheses has been increasing in Russia and other countries. Primarily this is due to the development of domestic cardiac surgery, which has made it possible to soften age limits and increase the number of surgeries in people over 65 years old. In order to assess the effectiveness of the “UniLine” prosthesis in treatment of aortic and mitral valve defects, an open prospective multicenter study of the safety and efficacy of the “UniLine” epoxy-treated prosthesis made from xenopericardium in the treatment of isolated aortic and mitral valve defects was planned and initiated, the study design and rationale are presented.

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