The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

  • STATUS
    Recruiting
  • End date
    Dec 31, 2026
  • participants needed
    500
  • sponsor
    Tomsk National Research Medical Center of the Russian Academy of Sciences
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Updated on 19 February 2024
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stenosis
aortic valve stenosis
mitral valve disease
bypass graft
aortic stenosis
aortic valve disease
mitral disease

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

Details
Condition Heart disease, Heart disease, VALVULAR HEART DISEASE
Age 60years - 100years
Treatment valve prosthetics
Clinical Study IdentifierNCT04442100
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
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