The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
1 other identifier
interventional
500
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2016
CompletedFirst Submitted
Initial submission to the registry
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
May 6, 2023
May 1, 2023
10.1 years
June 18, 2020
May 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
death
death from any cause
10 years after surgery
prosthetic complications
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
10 years after surgery
Study Arms (1)
bioprosthesis
EXPERIMENTALprosthetics of heart valves with dentures "MedEng-Bio"
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, 634012, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris N. Kozlov, MD
Tomsk National Research Medical Center of the Russian Academy of Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ekaterina Alekseevna Kosovskikh
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 22, 2020
Study Start
November 29, 2016
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 6, 2023
Record last verified: 2023-05