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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

About this trial

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

Qualifiers

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;

mitral valve disease requiring surgical disease

Disqualifiers

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.);

Trial design

Treatments tested in this trial

  • valve prosthetics

Treatment groups

500 Participants
are divided into 1 treatment group