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

NCT04442100 | Recruiting

• 1 other identifier: CRI-188
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (2)

• death

  death from any cause

  10 years after surgery

• prosthetic complications

  thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration

  10 years after surgery

Study Arms (1)

bioprosthesis

EXPERIMENTAL

prosthetics of heart valves with dentures "MedEng-Bio"

Procedure: valve prosthetics

Interventions

valve prosthetics PROCEDURE

prosthetics of heart valves with dentures "MedEng-Bio"

bioprosthesis

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• mitral valve disease requiring surgical disease

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634012, Russia

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Boris N. Kozlov, MD

  Tomsk National Research Medical Center of the Russian Academy of Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena B. Kim

CONTACT

ekim@cardio-tomsk.ru

Konstantin A. Petlin, PhD

CONTACT

+79138259164; kpetlin@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: November 29, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata.
• Access Criteria: Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.

Locations

RU (1)