The Study of Biological Prosthetic Heart Valves With the Easy Change System

Study Overview
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Brief Summary
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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

Detailed Description
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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. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.

Official Title
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The Study of Biological Prosthetic Heart Valves With the Easy Change System

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Procedure: valve prosthetics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis) mitral valve disease requiring surgical disease Exclusion Criteria: 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.); the diameter of the ascending aorta is more than 45 mm; unwillingness of the patient to participate in the study.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioprosthesis<br>prosthetics of heart valves with dentures MedEng-Bio | Procedure: valve prosthetics<br>* prosthetics of heart valves with dentures MedEng-Bio<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | death from any cause | 10 years after surgery | 
| prosthetic complications | thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration | 10 years after surgery |