Heart Valve DiseasesNCT04442100
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
A study testing valve prosthetics in people with Heart Valve Diseases, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- valve prosthetics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteRussia
- Study dates
- 29 Nov 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elena B. Kim contact
Russia1 site, 1 recruiting
- Recruiting
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, 634012
Elena B. Kim, ekim@cardio-tomsk.ru
Boris N Kozlov, MD
About this study
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
Read the 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.
- Conditions
- Heart Valve Diseases
- Being tested
- valve prosthetics
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valve prostheticsProcedure or surgery
prosthetics of heart valves with dentures "MedEng-Bio"
| Study group | Role | What they receive |
|---|---|---|
| bioprosthesis | Experimental | prosthetics of heart valves with dentures "MedEng-Bio" Receives: Procedure: valve prosthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
death from any cause
Measured: 10 years after surgery
prosthetic complications
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Measured: 10 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start29 Nov 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris N. Kozlov, Tomsk National Research Medical Center of the Russian Academy of Sciences
- Investigators
- Boris N. Kozlov, MD, Principal investigator, Tomsk National Research Medical Center of the Russian Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442100
- Sponsor's protocol ID
- CRI-188
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
- ClinicalTrials.gov ID
- NCT04442100
- Acronym / sponsor ID
- CRI-188
- Conditions
- Heart Valve Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bioprosthesis | Experimental | Procedure: valve prostheticsprosthetics of heart valves with dentures "MedEng-Bio" |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valve prostheticsprosthetics of heart valves with dentures "MedEng-Bio" | Procedure or surgery | bioprosthesis |
Primary outcome
death
Time frame: 10 years after surgery
death from any cause
prosthetic complications
Time frame: 10 years after surgery
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: 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.
Related trials for Heart Valve Diseases
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Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena B. Kim contact
Boris N. Kozlov, MD principal investigator
Tomsk National Research Medical Center of the Russian Academy of Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing valve prosthetics in people with Heart Valve Diseases, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena B. Kim (ekim@cardio-tomsk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: 10 years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.