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

Not Applicable

Recruiting

• Conditions: Heart Valve Diseases
• Interventions: Procedure: valve prosthetics

• Registration Number: NCT04442100
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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 implantation, and general mortality

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 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.

Study Timeline

• Study Start: 2016-11-29
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bioprosthesis	valve prosthetics	prosthetics of heart valves with dentures "MedEng-Bio"

Primary Outcome Measures

Name	Time	Method
prosthetic complications	10 years after surgery	thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
death	10 years after surgery	death from any cause

Trial Locations

Locations (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences; 🇷🇺 Tomsk, Tomsk Region, Russian Federation