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/NCT05998694</url>
    </required_header>
    <id_info>
      <org_study_id>(T-ara) TA0120</org_study_id>
      <nct_id>NCT05998694</nct_id>
    </id_info>
    <brief_title>Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis</brief_title>
    <acronym>TiAra</acronym>
    <official_title>Post-market Clinical Monitoring of the Safety and Efficacy of the Aortic Valve Bioprothesis &quot;ТiAra&quot; (T-ara)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Closed Joint-Stock Company NeoCor</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CT Medical Limited Liability Company</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</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 multicenter prospective cohort study is to evaluate the long-term safety and&#xD;
        efficacy of clinical outcomes of aortic valve replacement using the &quot;TiAra&quot; prosthesis with&#xD;
        or without concomitant procedures.&#xD;
  &#xD;
        Main research objectives:&#xD;
  &#xD;
          1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement&#xD;
             using the &quot;TiAra&quot; prosthesis.&#xD;
  &#xD;
          2. To study the hemodynamic characteristics of normally functioning &quot;TiAra&quot; prostheses in&#xD;
             the aortic position, as well as the condition of the heart chambers in short and&#xD;
             long-term period (up to 10 years) after the implantation.&#xD;
  &#xD;
          3. To assess complications of the early and mid-term follow-up periods of aortic valve&#xD;
             replacement using the &quot;TiAra&quot; prosthesis.&#xD;
  &#xD;
        This study does not presuppose implementation of comparison groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Cardiovascular system diseases are one of the main causes of death worldwide. Heart valve&#xD;
        diseases are considered one of the most important issues associated with the cardiovascular&#xD;
        system. The replacement of heart valves includes the production of prostheses that provide&#xD;
        functional consistency with exceptionally high reliability and appropriate fatigue strength.&#xD;
        The proposed new biological valve with a frame made of super-elastic material allows&#xD;
        preserves the natural biomechanics of the reconstructed valve and has high biocompatibility&#xD;
        and resistance to infection due to the use of biological material as a frame covering. The&#xD;
        &quot;TiAra&quot; bioprosthetic valve has the ability to deform during the cardiac cycle in accordance&#xD;
        with the deformations of the fibrous structures of the patients' aortic root. The implanted&#xD;
        valve fully integrates into the native aortic root.&#xD;
  &#xD;
        The purpose of these clinical trials is to obtain clinical data confirming the efficacy and&#xD;
        safety of the bioprosthesis under normal conditions in humans.&#xD;
  &#xD;
        The expected clinical benefit involves the treatment of valvular disease with restoration of&#xD;
        intracardiac hemodynamics during implantation of the &quot;TiAra&quot; bioprosthetic valve, followed by&#xD;
        remodeling of the heart chambers, which should lead to an improvement in heart function and&#xD;
        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. In order to reduce the risks caused by anticoagulant therapy,&#xD;
        it is planned to carry out measures aimed at restoring the sinus rhythm and ensuring proper&#xD;
        control of the indicators of the blood coagulation system.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2021</start_date>
    <completion_date type="Anticipated">August 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 10, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>1.Long-term safety and durability of the &quot;TiAra&quot; epoxy-treated prosthesis made with xenopericardium in the treatment of isolated aortic valve diseases.</measure>
      <time_frame>Up to 12 years from the moment of implantation .</time_frame>
      <description>Long-term safety of the &quot;TiAra&quot; epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases will be evaluated by the frequency of complications associated with the valve.&#xD;
  Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena:&#xD;
  Death Severe complications of the heart Life-threatening bleeding Any bioprosthesis-related dysfunction, migration, thrombosis or other complication requiring an open-heart surgery or repeated intervention.&#xD;
  Myocardial infarction (or ACS) or progression of a chronic form of ischemia requiring percutaneous coronary intervention and coronary artery bypass grafting Access site complications Stroke</description>
    </primary_outcome>
    <primary_outcome>
      <measure>2.Short-term safety of the &quot;TiAra&quot; epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases will be evaluated by the frequency of complications associated with the valve.</measure>
      <time_frame>Up to 12 years from the moment of implantation</time_frame>
      <description>Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena:&#xD;
  hemolysis hemolytic anemia a heart stroke myocardial infarction hemorrhaging and bleeding heart arrhythmia nonstructural dysfunction pannus prosthesis-patient mismatch dislocation paraprosthetic and transprosthetic regurgitation heart failure breast-pang structural deterioration valve thrombosis thromboembolism encarditis a reoperation</description>
    </primary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Aortic Valve Disease</condition>
    <condition>Artificial Heart Valves</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. The patient's written consent to participate in the study and the absence of&#xD;
               restrictions on physical movement (diseases of the musculoskeletal system and diseases&#xD;
               of the central nervous system, accompanied by cognitive disorders (disorientation,&#xD;
               inability to independently reach the destination).&#xD;
  &#xD;
            2. The patient is a resident of the city* (suburb) where the institution is conducting&#xD;
               study.&#xD;
  &#xD;
               * - participation is also possible for those living in the rural areas, but they have&#xD;
               to be able to make visits to the Research Center.&#xD;
  &#xD;
            3. Age: 60-70 years old with a life expectancy of 3 years or more. Or a person younger&#xD;
               than 60 with contraindications to taking anticoagulants, or with increased risk of&#xD;
               their use, consciously choosing a biological prosthesis for valve replacement.&#xD;
  &#xD;
            4. Isolated aortic valve disease.&#xD;
  &#xD;
            5. Real intervention on the heart valve is primary.&#xD;
  &#xD;
            6. Absence of concomitant interventions on the heart and thoracic aorta**.&#xD;
  &#xD;
               ** - Coronary artery bypass grafting, correction of tricuspid valve disease,&#xD;
               previously treated congenital heart defects, aortic intervention&#xD;
  &#xD;
            7. The intervention on the valve is planned (that is, it is not carried out in&#xD;
               expedited/urgent manner or is not a &quot;rescue&quot; operation).&#xD;
  &#xD;
            8. Absence of acute and subacute infective endocarditis.&#xD;
  &#xD;
            9. The following factors should not be present before surgery: high pulmonary&#xD;
               hypertension (pulmonary arterial systolic pressure more than 60 mmHg), functional&#xD;
               class 4 (according to the New York Heart Association Functional Classification) while&#xD;
               in ongoing treatment, left ventricular ejection fraction less than 30%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. The presence of severe somatic, neurological, mental diseases and infectious diseases&#xD;
               that worsen the prognosis of long-term survival (ischemic heart disease, tuberculosis,&#xD;
               human immunodeficiency viruses, Alzheimer's disease, epilepsy, insulin-requiring&#xD;
               diabetes, kidney disease with creatinine clearance less than 85 mL/min, chronic lung&#xD;
               disease requiring chronic corticosteroids and bronchodilators, multifocal&#xD;
               atherosclerosis (intermittent claudication, carotid arteries stenosis of more than&#xD;
               50%, prior and planned interventions on abdominal area, carotid arteries or arteries&#xD;
               of the lower extremities).&#xD;
  &#xD;
            2. The patient has any not related to the underlying cardiovascular system disease&#xD;
               pathology that will lead to the death of the patient in less than 1 year.&#xD;
  &#xD;
            3. The patient is currently participating in a study of a new drug or other medical&#xD;
               devices.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alexey V Evtushenko, MD,PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Research Institute for Complex Problems of Cardiovascular Diseases, Russia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Alexey V Evtushenko, MD,PhD</last_name>
      <phone>+79039515310</phone>
      <email>ave@kemcardio.ru</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Denis I Lebedev, MD</last_name>
      <phone>+79138456592</phone>
      <email>mdlebedevd@mail.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>Alexey V Evtushenko, MD, PhD</last_name>
        <phone>+79039515310</phone>
        <email>ave@kemcardio.ru</email>
      </contact>
      <contact_backup>
        <last_name>Denis I 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 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>aortic valve</keyword>
    <keyword>aortic valve bioprothesis TiAra</keyword>
    <keyword>valve bioprosthesis</keyword>
    <keyword>hemolysis</keyword>
    <keyword>hemolytic anemia</keyword>
    <keyword>a heart stroke</keyword>
    <keyword>myocardial infarction</keyword>
    <keyword>hemorrhaging and bleeding</keyword>
    <keyword>heart arrhythmia</keyword>
    <keyword>nonstructural dysfunction</keyword>
    <keyword>pannus</keyword>
    <keyword>prosthesis-patient mismatch</keyword>
    <keyword>dislocation</keyword>
    <keyword>paraprosthetic and transprosthetic regurgitation</keyword>
    <keyword>heart failure</keyword>
    <keyword>breast-pang</keyword>
    <keyword>structural deterioration</keyword>
    <keyword>valve thrombosis</keyword>
    <keyword>thromboembolism</keyword>
    <keyword>encarditis</keyword>
    <keyword>a reoperation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Disease</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/NCT05998694
  org study id: (T-ara) TA0120
  nct id: NCT05998694
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multicenter prospective cohort study is to evaluate the long-term safety and
        efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with
        or without concomitant procedures.
  
        Main research objectives:
  
          1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement
             using the "TiAra" prosthesis.
  
          2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in
             the aortic position, as well as the condition of the heart chambers in short and
             long-term period (up to 10 years) after the implantation.
  
          3. To assess complications of the early and mid-term follow-up periods of aortic valve
             replacement using the "TiAra" prosthesis.
  
        This study does not presuppose implementation of comparison groups.
  Cardiovascular system diseases are one of the main causes of death worldwide. Heart valve
        diseases are considered one of the most important issues associated with the cardiovascular
        system. The replacement of heart valves includes the production of prostheses that provide
        functional consistency with exceptionally high reliability and appropriate fatigue strength.
        The proposed new biological valve with a frame made of super-elastic material allows
        preserves the natural biomechanics of the reconstructed valve and has high biocompatibility
        and resistance to infection due to the use of biological material as a frame covering. The
        "TiAra" bioprosthetic valve has the ability to deform during the cardiac cycle in accordance
        with the deformations of the fibrous structures of the patients' aortic root. The implanted
        valve fully integrates into the native aortic root.
  
        The purpose of these clinical trials is to obtain clinical data confirming the efficacy and
        safety of the bioprosthesis under normal conditions in humans.
  
        The expected clinical benefit involves the treatment of valvular disease with restoration of
        intracardiac hemodynamics during implantation of the "TiAra" 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. In order to reduce the risks caused by anticoagulant therapy,
        it is planned to carry out measures aimed at restoring the sinus rhythm and ensuring proper
        control of the indicators of the blood coagulation system.
  observational model: Case-Control
  time perspective: Prospective
  measure: 1.Long-term safety and durability of the "TiAra" epoxy-treated prosthesis made with xenopericardium in the treatment of isolated aortic valve diseases.
  time frame: Up to 12 years from the moment of implantation .
  description: Long-term safety of the "TiAra" epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases will be evaluated by the frequency of complications associated with the valve.
  Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena:
  Death Severe complications of the heart Life-threatening bleeding Any bioprosthesis-related dysfunction, migration, thrombosis or other complication requiring an open-heart surgery or repeated intervention.
  Myocardial infarction (or ACS) or progression of a chronic form of ischemia requiring percutaneous coronary intervention and coronary artery bypass grafting Access site complications Stroke
  measure: 2.Short-term safety of the "TiAra" epoxy-treated prosthesis made with xenopericardium in the treatment of isolated mitral and aortic valve diseases will be evaluated by the frequency of complications associated with the valve.
  time frame: Up to 12 years from the moment of implantation
  description: Device safety is defined as the absence of severe adverse events associated with the device or procedure, assessed by the following clinical phenomena:
  hemolysis hemolytic anemia a heart stroke myocardial infarction hemorrhaging and bleeding heart arrhythmia nonstructural dysfunction pannus prosthesis-patient mismatch dislocation paraprosthetic and transprosthetic regurgitation heart failure breast-pang structural deterioration valve thrombosis thromboembolism encarditis a reoperation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Alexey V Evtushenko, MD,PhD
  role: Principal Investigator
  affiliation: Research Institute for Complex Problems of Cardiovascular Diseases, Russia
  last name: Alexey V Evtushenko, MD,PhD
  phone: +79039515310
  email: ave@kemcardio.ru
  last name: Denis I Lebedev, MD
  phone: +79138456592
  email: mdlebedevd@mail.ru
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Russian Federation
  responsible party type: Sponsor
  mesh term: Aortic Valve Disease