Status:
RECRUITING
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Lead Sponsor:
Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions:
Heart Valve Diseases
Eligibility:
All Genders
60+ years
Phase:
NA
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 implanta...
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 implanta...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04442100
Start Date
November 29 2016
End Date
December 31 2026
Last Update
May 6 2023
Active Locations (1)
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1
Tomsk National Research Medical Center of the Russian Academy of Sciences
Tomsk, Tomsk Oblast, Russia, 634012