<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04442100</url>
  </required_header>
  <id_info>
    <org_study_id>Easy Change</org_study_id>
    <nct_id>NCT04442100</nct_id>
  </id_info>
  <brief_title>The Study of Biological Prosthetic Heart Valves With the &quot;Easy Change&quot; System</brief_title>
  <official_title>The Study of Biological Prosthetic Heart Valves With the &quot;Easy Change&quot; System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tomsk National Research Medical Center of the Russian Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tomsk National Research Medical Center of the Russian Academy of Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study of new biological heart valves with the &quot;easy change&quot; system, including an&#xD;
      assessment of the basic hemodynamic characteristics of the prosthesis, complications&#xD;
      associated with valve implantation, and general mortality&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study of new biological heart valves with the &quot;easy change&quot; system, including an&#xD;
      assessment of the basic hemodynamic characteristics of the prosthesis, complications&#xD;
      associated with valve implantation, and general mortality. Antithrombotic therapy after new&#xD;
      biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of&#xD;
      aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The&#xD;
      quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery&#xD;
      is assessed by six-minute walking test and plasma BNP level.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 29, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>death</measure>
    <time_frame>10 years after surgery</time_frame>
    <description>death from any cause</description>
  </primary_outcome>
  <primary_outcome>
    <measure>prosthetic complications</measure>
    <time_frame>10 years after surgery</time_frame>
    <description>thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Heart Valve Diseases</condition>
  <arm_group>
    <arm_group_label>bioprosthesis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prosthetics of heart valves with dentures &quot;MedEng-Bio&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>valve prosthetics</intervention_name>
    <description>prosthetics of heart valves with dentures &quot;MedEng-Bio&quot;</description>
    <arm_group_label>bioprosthesis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. aortic valve disease requiring surgical disease patients without symptoms with severe&#xD;
             aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient&#xD;
             more than 40 mm RT. Art;&#xD;
&#xD;
             o patients who require coronary artery bypass grafting with moderate aortic stenosis -&#xD;
             indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT.&#xD;
             Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of&#xD;
             the severity of stenosis)&#xD;
&#xD;
          2. mitral valve disease requiring surgical disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. the need for prosthetics of two or more valves&#xD;
&#xD;
          2. patients with a decrease in LVEF of less than 45%;&#xD;
&#xD;
          3. the presence of a competing disease or concomitant pathology that significantly&#xD;
             affects the prognosis of quality of life or the likelihood of death&#xD;
&#xD;
          4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);&#xD;
&#xD;
          5. the diameter of the ascending aorta is more than 45 mm;&#xD;
&#xD;
          6. unwillingness of the patient to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boris N. Kozlov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tomsk National Research Medical Center of the Russian Academy of Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ekaterina A/ Kosovskikh</last_name>
    <phone>+79528912091</phone>
    <email>katekorovina93@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Konstantin A. Petlin, PhD</last_name>
    <phone>+79138259164</phone>
    <email>kpetlin@yandex.ru</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Tomsk National Research Medical Center of the Russian Academy of Sciences</name>
      <address>
        <city>Tomsk</city>
        <state>Tomsk Region</state>
        <zip>634012</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ekaterina A Kosovskikh</last_name>
      <phone>+79528912091</phone>
      <email>katekorovina93@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Boris N Kozlov, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Konstentin A Petlin, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tomsk National Research Medical Center of the Russian Academy of Sciences</investigator_affiliation>
    <investigator_full_name>Konstantin A. Petlin</investigator_full_name>
    <investigator_title>Ekaterina Alekseevna Kosovskikh</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04442100
org study id: Easy Change
nct id: NCT04442100
lead sponsor: 
has dmc: No
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
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: death
time frame: 10 years after surgery
description: death from any cause
measure: prosthetic complications
time frame: 10 years after surgery
description: thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
arm group label: bioprosthesis
arm group type: Experimental
description: prosthetics of heart valves with dentures "MedEng-Bio"
intervention type: Procedure
intervention name: valve prosthetics
description: prosthetics of heart valves with dentures "MedEng-Bio"
arm group label: bioprosthesis
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Boris N. Kozlov, MD
role: Principal Investigator
affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
last name: Ekaterina A/ Kosovskikh
phone: +79528912091
email: katekorovina93@gmail.com
last name: Konstantin A. Petlin, PhD
phone: +79138259164
email: kpetlin@yandex.ru
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Russian Federation
responsible party type: Principal Investigator
investigator affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
investigator full name: Konstantin A. Petlin
investigator title: Ekaterina Alekseevna Kosovskikh
mesh term: Heart Valve Diseases