About this trial
The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;
mitral valve disease requiring surgical disease
Disqualifiers
the need for prosthetics of two or more valves
patients with a decrease in LVEF of less than 45%;
the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
Trial design
Single group
Treatments tested in this trial
valve prosthetics
Procedure/Surgeryprosthetics of heart valves with dentures "MedEng-Bio"
Treatment groups
Trial outcomes
Primary outcomes
death
death from any cause
prosthetic complications
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Sponsors and contacts
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