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

May 3, 2023 updated by: Konstantin A. Petlin, Tomsk National Research Medical Center of the Russian Academy of Sciences
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Konstantin A. Petlin, PhD
  • Phone Number: +79138259164
  • Email: kpetlin@yandex.ru

Study Locations

  • Russian Federation
    • Tomsk Region
      • Tomsk, Tomsk Region, Russian Federation, 634012
        • Recruiting
        • Tomsk National Research Medical Center of the Russian Academy of Sciences
        • Contact:
        • Principal Investigator:
          • Boris N Kozlov, MD
        • Sub-Investigator:
          • Konstentin A Petlin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bioprosthesis
prosthetics of heart valves with dentures "MedEng-Bio"
Procedure: valve prosthetics
prosthetics of heart valves with dentures "MedEng-Bio"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 10 years after surgery
death from any cause
10 years after surgery
prosthetic complications
Time Frame: 10 years after surgery
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
10 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2016

Primary Completion (Anticipated)

December 31, 2026

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

June 18, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 3, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Easy Change

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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