NCT04442100 The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
| NCT ID | NCT04442100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Condition | Heart Valve Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2016-11-29 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2016-11-29 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Boris N. Kozlov, MD
PRINCIPAL INVESTIGATOR
Tomsk National Research Medical Center of the Russian Academy of Sciences
Frequently Asked Questions
Who can join the NCT04442100 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Heart Valve Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04442100 currently recruiting?
Yes, NCT04442100 is actively recruiting participants. Contact the research team at katekorovina93@gmail.com for enrollment information.
Where is the NCT04442100 trial being conducted?
This trial is being conducted at Tomsk, Russia.
Who is sponsoring the NCT04442100 clinical trial?
NCT04442100 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences. The principal investigator is Boris N. Kozlov, MD at Tomsk National Research Medical Center of the Russian Academy of Sciences. The trial plans to enroll 500 participants.