Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, 634012, Russia
Location status: Recruiting
NCT Number: NCT04442100
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
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Tomsk, Tomsk Oblast, 634012, Russia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
Exclusion criteria
prosthetics of heart valves with dentures "MedEng-Bio"
Time frame: 10 years after surgery
death from any cause
Time frame: 10 years after surgery
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Interested in participating?
Request InfoTomsk National Research Medical Center of the Russian Academy of Sciences
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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