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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • valve prosthetics

    Procedure/Surgery

    prosthetics of heart valves with dentures "MedEng-Bio"

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: bioprosthesisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

death

death from any cause

Time frame
10 years after surgery
2

prosthetic complications

thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration

Time frame
10 years after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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