Heart Valve Diseases
Conditions
Brief summary
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
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.
Interventions
PROCEDUREvalve prosthetics
prosthetics of heart valves with dentures "MedEng-Bio"
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. mitral valve disease requiring surgical disease
Exclusion criteria
1. the need for prosthetics of two or more valves 2. patients with a decrease in LVEF of less than 45%; 3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death 4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.); 5. the diameter of the ascending aorta is more than 45 mm; 6. unwillingness of the patient to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | 10 years after surgery | death from any cause |
| prosthetic complications | 10 years after surgery | thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration |
Countries
Russia
Contacts
CONTACTElena B. Kim
CONTACTKonstantin A. Petlin, PhD
PRINCIPAL_INVESTIGATORBoris N. Kozlov, MD
Tomsk National Research Medical Center of the Russian Academy of Sciences
Outcome results
None listed