xml: <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/NCT06025149</url>
    </required_header>
    <id_info>
      <org_study_id>UniLine</org_study_id>
      <nct_id>NCT06025149</nct_id>
    </id_info>
    <brief_title>The Study on the Use of &quot;UniLine&quot; Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases</brief_title>
    <acronym>Uniline</acronym>
    <official_title>Open, Prospective, Multicenter Study of the Safety and Efficacy of &quot;UniLine&quot; Epoxy-treated Prosthesis Made From Xenopericardium in the Treatment of Isolated Aortic and Mitral Valve Diseases</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Closed Joint-Stock Company NeoCor</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>CT Medical Limited Liability Company</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Closed Joint-Stock Company NeoCor</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this open, prospective, multicenter study is analyze long-term outcomes of&#xD;
        aortic/mitral valve replacement using the &quot;UniLine&quot; bioprosthesis in patients with acquired&#xD;
        aortic or mitral valve diseases.&#xD;
  &#xD;
        Main research objectives:&#xD;
  &#xD;
        To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the&#xD;
        &quot;UniLine&quot; bioprosthesis.&#xD;
  &#xD;
        To study the hemodynamic characteristics of normally functioning &quot;UniLine &quot; prostheses in the&#xD;
        mitral or aortic valve position based on the transthoracic echocardiography data.&#xD;
  &#xD;
        To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the&#xD;
        results of their treatment.&#xD;
  &#xD;
        To analyze the frequency of major serious adverse events associated with the &quot;UniLine&quot;&#xD;
        bioprosthesis or procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acquired heart diseases (AHDs) remain one of the most frequent causes of cardiac mortality&#xD;
        and disability. In Russia, this kind of disease accounts for 7 to 25 % of all cardiovascular&#xD;
        diseases, and is third most common cause of heart failure.&#xD;
  &#xD;
        Heart valve replacement using a prosthetic heart valve remains the main and most effective&#xD;
        method of treatment of AHDs. In Russia, AHDs are treated in more than 40 subjects by&#xD;
        specialists from 92 medical institutions. Valve replacements, being high-tech methods of&#xD;
        treatment, most effectively prolong the life of patients. Timely correction of AHD allows&#xD;
        75-95 % of patients to return to a normal lifestyle.&#xD;
  &#xD;
        The aim of this study is to evaluate the safety and effectiveness of the &quot;UniLine&quot;&#xD;
        epoxy-treated bioprosthesis in the treatment of isolated mitral or aortic heart valve&#xD;
        diseases.&#xD;
  &#xD;
        The expected clinical benefit involves the treatment of valvular disease with restoration of&#xD;
        intracardiac hemodynamics during implantation of the &quot;UniLine &quot; bioprosthetic valve, followed&#xD;
        by remodeling of the heart chambers, which should lead to an improvement in heart function&#xD;
        and quality of life of the patient.&#xD;
  &#xD;
        The expected risks are associated with taking anticoagulant therapy during the first three&#xD;
        months after implantation, or as a result of prolonged anticoagulant therapy, in the presence&#xD;
        of concomitant rhythm disturbances, and consist in the possibility of hemorrhagic or&#xD;
        thromboembolic complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 1, 2018</start_date>
    <completion_date type="Anticipated">January 31, 2035</completion_date>
    <primary_completion_date type="Anticipated">September 9, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Safety of the Bioprosthetic Valve</measure>
      <time_frame>12 years since the replacement surgery</time_frame>
      <description>Safety of using the bioprosthesis is defined as the absence of major adverse events related to the device or procedure, assessed using the following clinical phenomena:&#xD;
  Fatal outcome: a) all-cause death; b) related to cardiovascular diseases; c) related to the dysfunction of the prosthesis.&#xD;
  Life-threatening bleeding.&#xD;
  Any dysfunction associated with the bioprosthesis (stenosis, regurgitation), migration of the device, thrombosis or other complication requiring surgical intervention.&#xD;
  Any dysfunction associated with the bioprosthesis that does not require surgical intervention.&#xD;
  Myocardial infarction (or stroke) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass graft surgery&#xD;
  Stroke</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long-Term Durability of the Bioprosthetic Valve</measure>
      <time_frame>12 years since the replacement surgery</time_frame>
      <description>It will be evaluated by measuring the hemodynamic characteristics of the prosthetic valve, assessed by echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hemodynamic characteristics of the Bioprosthetic Valve</measure>
      <time_frame>12 years since the replacement surgery</time_frame>
      <description>They will be assessed by using echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Aortic Valve Disease</condition>
    <condition>Mitral Valve Disease</condition>
    <eligibility>
      <study_pop>
        <textblock>
          As part of these clinical trials (studies), the use of comparison groups is not planned.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Provided informed consent to participate in the study.&#xD;
  &#xD;
            2. Must be aged 18 years and older.&#xD;
  &#xD;
            3. Patients with isolated acquired mitral or aortic valve disease.&#xD;
  &#xD;
            4. No prior heart valve replacement, current replacement must be planned (not conducted&#xD;
               in an urgent/ emergency manner), using the &quot;UniLine&quot; biological prosthesis made from&#xD;
               xenopericardium.&#xD;
  &#xD;
            5. Patient must be able to visit the Research Center.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Mechanical or biological prosthesis in another position. Patients with tricuspid valve&#xD;
               repair may be included in the study.&#xD;
  &#xD;
            2. Prior heart valve replacement.&#xD;
  &#xD;
            3. Concomitant interventions on the heart (coronary artery bypass grafting, coronary&#xD;
               heart disease treatment, surgical reconstruction of a left ventricular aneurysm) and&#xD;
               thoracic aorta.&#xD;
  &#xD;
            4. Patients with cancer in history.&#xD;
  &#xD;
            5. Patients with musculoskeletal conditions with severe movement disorders and diseases&#xD;
               of the central nervous system, accompanied by cognitive disorders (disorientation,&#xD;
               inability to independently reach the destination).&#xD;
  &#xD;
            6. Acute or subacute stages of infective endocarditis.&#xD;
  &#xD;
            7. Class IV heart failure according to the New York Heart Association Functional&#xD;
               Classification with ongoing therapy, left ventricular ejection fraction less than 40%,&#xD;
               myocardial infarction less than 90 days old, angina pectoris grade 4.&#xD;
  &#xD;
            8. The presence of severe somatic, neurological, mental and infectious diseases that&#xD;
               worsen the prognosis of long-term survival: tuberculosis, human immunodeficiency&#xD;
               virus, Alzheimer's disease, epilepsy, chronic kidney disease stage 3b (Glomerular&#xD;
               Filtration Rate less than 30 mL/ min / 1.73 m²), chronic lung diseases requiring&#xD;
               constant intake of corticosteroids and bronchodilators, multifocal atherosclerosis&#xD;
               (grade 3 chronic lower limb ischemia, stenosis of the carotid arteries more than 50%,&#xD;
               prior and planned interventions on the abdominal aorta, carotid arteries or arteries&#xD;
               of the lower extremities).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexander Bogachev-Prokofiev, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Medical Research Center named after Academician E.N. Meshalkin</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Alexey Evtushenko, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Research Institute for Complex Issues of Cardiovascular Diseases</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Evgeny Bazdyrev, MD, PhD</last_name>
      <phone>+7-3842-64-42-40</phone>
      <email>clinicresearch@kemcardio.ru</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michael Karelin</last_name>
      <phone>8 (913) 433 7669</phone>
      <email>karelin@ctmedical.ru</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</name>
        <address>
          <city>Kemerovo</city>
          <state>Kemerovo Region</state>
          <zip>650002</zip>
          <country>Russian Federation</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Evgeny Bazdyrev, MD, PhD</last_name>
        <phone>+7-3842-64-42-40</phone>
        <email>clinicresearch@kemcardio.ru</email>
      </contact>
      <contact_backup>
        <last_name>Denis Lebedev, MD</last_name>
        <phone>+79138456592</phone>
        <email>mdlebedev@mail.ru</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Russian Federation</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>UniLine biological prosthesis</keyword>
    <keyword>Acquired valve disease</keyword>
    <keyword>Acquired aortic valve disease</keyword>
    <keyword>Acquired mitral valve disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Disease</mesh_term>
      <mesh_term>Heart Valve Diseases</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06025149
  org study id: UniLine
  nct id: NCT06025149
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this open, prospective, multicenter study is analyze long-term outcomes of
        aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired
        aortic or mitral valve diseases.
  
        Main research objectives:
  
        To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the
        "UniLine" bioprosthesis.
  
        To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the
        mitral or aortic valve position based on the transthoracic echocardiography data.
  
        To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the
        results of their treatment.
  
        To analyze the frequency of major serious adverse events associated with the "UniLine"
        bioprosthesis or procedure.
  Acquired heart diseases (AHDs) remain one of the most frequent causes of cardiac mortality
        and disability. In Russia, this kind of disease accounts for 7 to 25 % of all cardiovascular
        diseases, and is third most common cause of heart failure.
  
        Heart valve replacement using a prosthetic heart valve remains the main and most effective
        method of treatment of AHDs. In Russia, AHDs are treated in more than 40 subjects by
        specialists from 92 medical institutions. Valve replacements, being high-tech methods of
        treatment, most effectively prolong the life of patients. Timely correction of AHD allows
        75-95 % of patients to return to a normal lifestyle.
  
        The aim of this study is to evaluate the safety and effectiveness of the "UniLine"
        epoxy-treated bioprosthesis in the treatment of isolated mitral or aortic heart valve
        diseases.
  
        The expected clinical benefit involves the treatment of valvular disease with restoration of
        intracardiac hemodynamics during implantation of the "UniLine " bioprosthetic valve, followed
        by remodeling of the heart chambers, which should lead to an improvement in heart function
        and quality of life of the patient.
  
        The expected risks are associated with taking anticoagulant therapy during the first three
        months after implantation, or as a result of prolonged anticoagulant therapy, in the presence
        of concomitant rhythm disturbances, and consist in the possibility of hemorrhagic or
        thromboembolic complications.
  observational model: Cohort
  time perspective: Prospective
  measure: Safety of the Bioprosthetic Valve
  time frame: 12 years since the replacement surgery
  description: Safety of using the bioprosthesis is defined as the absence of major adverse events related to the device or procedure, assessed using the following clinical phenomena:
  Fatal outcome: a) all-cause death; b) related to cardiovascular diseases; c) related to the dysfunction of the prosthesis.
  Life-threatening bleeding.
  Any dysfunction associated with the bioprosthesis (stenosis, regurgitation), migration of the device, thrombosis or other complication requiring surgical intervention.
  Any dysfunction associated with the bioprosthesis that does not require surgical intervention.
  Myocardial infarction (or stroke) or progression of a chronic form of ischemia requiring percutaneous coronary intervention or coronary artery bypass graft surgery
  Stroke
  measure: Long-Term Durability of the Bioprosthetic Valve
  time frame: 12 years since the replacement surgery
  description: It will be evaluated by measuring the hemodynamic characteristics of the prosthetic valve, assessed by echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).
  measure: Hemodynamic characteristics of the Bioprosthetic Valve
  time frame: 12 years since the replacement surgery
  description: They will be assessed by using echocardiography: maximum, average gradients and effective orifice area (absolute and indexed values).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Alexander Bogachev-Prokofiev, MD, PhD
  role: Principal Investigator
  affiliation: National Medical Research Center named after Academician E.N. Meshalkin
  last name: Alexey Evtushenko, MD, PhD
  role: Principal Investigator
  affiliation: Research Institute for Complex Issues of Cardiovascular Diseases
  last name: Evgeny Bazdyrev, MD, PhD
  phone: +7-3842-64-42-40
  email: clinicresearch@kemcardio.ru
  last name: Michael Karelin
  phone: 8 (913) 433 7669
  email: karelin@ctmedical.ru
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Aortic Valve Disease
  mesh term: Heart Valve Diseases