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/NCT06009588</url>
    </required_header>
    <id_info>
      <org_study_id>2023-2024</org_study_id>
      <nct_id>NCT06009588</nct_id>
    </id_info>
    <brief_title>Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement</brief_title>
    <official_title>Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China National Center for Cardiovascular Diseases</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China National Center for Cardiovascular Diseases</source>
    <oversight_info>
      <has_dmc>Yes</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>
        This study aimed at comparing the performance of self-expandable valves versus&#xD;
        balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter&#xD;
        aortic valve replacement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS),&#xD;
        especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic&#xD;
        valve replacement (SAVR), current guidelines recommend concomitant aortic repair or&#xD;
        replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.&#xD;
  &#xD;
        Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management&#xD;
        of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR,&#xD;
        simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility&#xD;
        of the procedure and the fate of AA after the procedure in these patients remain unclear.&#xD;
        Moreover, there are limited data comparing the performance of self-expandable valves versus&#xD;
        balloon-expandable valves in these patients. The aim of the present study is to evaluate the&#xD;
        impact of type of transcatheter heart valves on intra-procedural device success and&#xD;
        post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">July 11, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 11, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Self-expandable valve group vs. Balloon-expandable valve group</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>30-day all-cause mortality</measure>
      <time_frame>30 days after TAVR procedure</time_frame>
      <description>all-cause mortality within 30 days after TAVR procedure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30-day adverse aortic events</measure>
      <time_frame>30 days after TAVR procedure</time_frame>
      <description>aortic death, aortic dissection, or aortic rupture</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The rate of device success</measure>
      <time_frame>30 days</time_frame>
      <description>Device success is defined as following:&#xD;
  Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication)&#xD;
  Freedom from mortality&#xD;
  Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication&#xD;
  Intended performance of the valve (mean gradient &lt;20 mmHg, peak velocity &lt;3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1-year all-cause mortality</measure>
      <time_frame>1 year after TAVR procedure</time_frame>
      <description>all-cause mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year cardiovascular mortality</measure>
      <time_frame>1 year after TAVR procedure</time_frame>
      <description>Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>1-year adverse aortic events</measure>
      <time_frame>1 year after TAVR procedure</time_frame>
      <description>aortic death, aortic dissection, or aortic rupture</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ascending aortic diameter expansion rate ≥3mm/year</measure>
      <time_frame>1 year after TAVR procedure</time_frame>
      <description>Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospitalization (or re-hospitalization)</measure>
      <time_frame>1 year after TAVR procedure</time_frame>
      <description>Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.&#xD;
  Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments &lt;24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Aortic Stenosis</condition>
    <condition>Ascending Aortic Dilatation</condition>
    <arm_group>
      <arm_group_label>Self-expandable valve group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients using self-expandable valves</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Balloon-expandable valve group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients using balloon-expandable valves</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>type of transcatheter heart valves</intervention_name>
      <description>patients undergoing TAVR use either self-expandable valves or balloon-expandable valves</description>
      <arm_group_label>Balloon-expandable valve group</arm_group_label>
      <arm_group_label>Self-expandable valve group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Severe aortic stenosis;&#xD;
  &#xD;
            -  Transfemoral access;&#xD;
  &#xD;
            -  Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and &lt;55mm;&#xD;
  &#xD;
            -  Anticipated life expectancy &gt;1 year;&#xD;
  &#xD;
            -  Age ≥ 65 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dominant aortic regurgitation,;&#xD;
  &#xD;
            -  A history of SAVR or TAVR;&#xD;
  &#xD;
            -  A history of aortic surgery;&#xD;
  &#xD;
            -  Emergent TAVR.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiangbin Pan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Structural Heart Disease, National Center for Cardiovascular Disease, China &amp; Fuwai Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Center for Cardiovascular Disease, China &amp; Fuwai Hospital, Chinese Academy of Medical Sciences &amp; Peking Union Medical College</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100037</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.</citation>
      <PMID>33888385</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 20, 2023</last_update_submitted>
    <last_update_submitted_qc>August 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Transcatheter aortic valve replacement</keyword>
    <keyword>Self-expandable valve</keyword>
    <keyword>Balloon-expandable valve</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aortic Valve Stenosis</mesh_term>
      <mesh_term>Aneurysm, Ascending Aorta</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06009588
  org study id: 2023-2024
  nct id: NCT06009588
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed at comparing the performance of self-expandable valves versus
        balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter
        aortic valve replacement.
  Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS),
        especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic
        valve replacement (SAVR), current guidelines recommend concomitant aortic repair or
        replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.
  
        Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management
        of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR,
        simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility
        of the procedure and the fate of AA after the procedure in these patients remain unclear.
        Moreover, there are limited data comparing the performance of self-expandable valves versus
        balloon-expandable valves in these patients. The aim of the present study is to evaluate the
        impact of type of transcatheter heart valves on intra-procedural device success and
        post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Self-expandable valve group vs. Balloon-expandable valve group
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  masking description: Surgeons are aware of randomisation results, however, participants and research staff are all blinded to the randomisation schemes.
  measure: 30-day all-cause mortality
  time frame: 30 days after TAVR procedure
  description: all-cause mortality within 30 days after TAVR procedure
  measure: 30-day adverse aortic events
  time frame: 30 days after TAVR procedure
  description: aortic death, aortic dissection, or aortic rupture
  measure: The rate of device success
  time frame: 30 days
  description: Device success is defined as following:
  Technical success (Freedom from mortality; Successful access, delivery of the device, and retrieval of the delivery system; Correct positioning of a single prosthetic heart valve into the proper anatomical location; Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication)
  Freedom from mortality
  Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
  Intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index $0.25, and less than moderate aortic regurgitation)
  measure: 1-year all-cause mortality
  time frame: 1 year after TAVR procedure
  description: all-cause mortality
  measure: 1-year cardiovascular mortality
  time frame: 1 year after TAVR procedure
  description: Related to heart failure, cardiogenic shock, bioprosthetic valve dysfunction, myocardial infarction, stroke, thromboembolism, bleeding, tamponade, vascular complication, arrhythmia or conduction system disturbances, cardiovascular infection (e.g. mediastinitis, endocarditis), or other clear cardiovascular cause
  measure: 1-year adverse aortic events
  time frame: 1 year after TAVR procedure
  description: aortic death, aortic dissection, or aortic rupture
  measure: Ascending aortic diameter expansion rate ≥3mm/year
  time frame: 1 year after TAVR procedure
  description: Expansion rate was calculated as the change of ascending aortic diameters (before the procedure and at the latest follow-up) divided by the follow-up period.
  measure: Hospitalization (or re-hospitalization)
  time frame: 1 year after TAVR procedure
  description: Any admission after the index hospitalization or study enrolment to an inpatient unit or hospital ward for ≥24 h, including an emergency department stay.
  Hospitalizations planned for pre-existing conditions are excluded unless there is worsening of the baseline condition. Visits to urgent care centres or emergency departments <24 h may also be included if substantive intensification of therapy changes (e.g. heart failure episodes) are enacted (e.g. intravenous diuretics, significant increases in drug therapy dosages or addition of new pharmacotherapy agents)
  arm group label: Self-expandable valve group
  arm group type: Experimental
  description: Patients using self-expandable valves
  arm group label: Balloon-expandable valve group
  arm group type: Experimental
  description: Patients using balloon-expandable valves
  intervention type: Device
  intervention name: type of transcatheter heart valves
  description: patients undergoing TAVR use either self-expandable valves or balloon-expandable valves
  arm group label: Balloon-expandable valve group
  arm group label: Self-expandable valve group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Xiangbin Pan, MD
  role: Principal Investigator
  affiliation: Department of Structural Heart Disease, National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
  facility: 
  country: China
  citation: VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun 1;77(21):2717-2746. doi: 10.1016/j.jacc.2021.02.038. Epub 2021 Apr 19.
  PMID: 33888385
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Aneurysm, Ascending Aorta
  sharing ipd: No