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

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Enrolling

Conditions: Heart Valve Diseases

Treatments: Procedure: valve prosthetics

Study type: Interventional

Funder types: Other

Identifiers

NCT04442100

Easy Change

Details and patient eligibility

About

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

Full 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 implantation, and general mortality. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.

Enrollment: 500 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

bioprosthesis

Experimental group

Description:

prosthetics of heart valves with dentures "MedEng-Bio"

Treatment:

Procedure: valve prosthetics