An interventional study of valve prosthetics in Heart Valve Diseases, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. Recruiting at 1 site in Russia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences · Not applicable, Interventional, and Treatment
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
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.
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 311 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Tomsk National Research Medical Center of the Russian Academy of Sciences is the lead sponsor of 73 studies on the registry; 19 are open to participants now.
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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)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
prosthetics of heart valves with dentures "MedEng-Bio"
Procedure: valve prosthetics
prosthetics of heart valves with dentures "MedEng-Bio"
death
death from any cause
Time frame: 10 years after surgery
prosthetic complications
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Time frame: 10 years after surgery
Plan to share: Yes — Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
Access criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.
No publications or documents are linked to this record.
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Tomsk National Research Medical Center of the Russian Academy of Sciences