<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/NCT04500964</url>
  </required_header>
  <id_info>
    <org_study_id>TRANSIT</org_study_id>
    <nct_id>NCT04500964</nct_id>
  </id_info>
  <brief_title>Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve</brief_title>
  <official_title>Transcatheter Aortic Valve Replacement for Failed Transcatheter Aortic Valve. An International Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Policlinico S. Donato</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Policlinico S. Donato</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to&#xD;
      further transcatheter aortic valve replacement (TAVR).&#xD;
&#xD;
      The purpouse of this study is to evaluate the indication to a second TAVR, the selection&#xD;
      criteria of the second transcatheter aortic valve, procedural and clinical outcomes.&#xD;
&#xD;
      The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Overall mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Overall mortality and Cardiovascular mortality at 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>VARC-3 Events</measure>
    <time_frame>1 year</time_frame>
    <description>Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">173</enrollment>
  <condition>Failed Transcather Aortic Valve</condition>
  <arm_group>
    <arm_group_label>failed transcather aortic valve (Stenotic)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>failed transcather aortic valve (Regurgitation)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>failed transcather aortic valve (Regurgitation and stenotic))</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR</intervention_name>
    <description>Trancatheter aortic valve replacement</description>
    <arm_group_label>failed transcather aortic valve (Regurgitation and stenotic))</arm_group_label>
    <arm_group_label>failed transcather aortic valve (Regurgitation)</arm_group_label>
    <arm_group_label>failed transcather aortic valve (Stenotic)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with failed transcather aortic valve&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with failed transcather aortic valve (stenotic, regurgitant, both) and&#xD;
             indication to further transcatheter aortic valve replacement (TAVR).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <state>Milan</state>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Policlinico S. Donato</investigator_affiliation>
    <investigator_full_name>Luca Testa</investigator_full_name>
    <investigator_title>Interventional Cardiology</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04500964
org study id: TRANSIT
nct id: NCT04500964
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Patients with failed transcather aortic valve (stenotic, regurgitant, both) and indication to
      further transcatheter aortic valve replacement (TAVR).

      The purpouse of this study is to evaluate the indication to a second TAVR, the selection
      criteria of the second transcatheter aortic valve, procedural and clinical outcomes.

      The primary endpoint of the study is overall mortality and Cardiovascular mortality at 1 year
observational model: Cohort
time perspective: Prospective
measure: Overall mortality
time frame: 1 year
description: Overall mortality and Cardiovascular mortality at 1 year
measure: VARC-3 Events
time frame: 1 year
description: Cerebrovascular events, bleeding complications, periprocedural MI, conduction disturbances, BVF, procedural success, device success, AKI (all according to VARC-2).
arm group label: failed transcather aortic valve (Stenotic)
arm group label: failed transcather aortic valve (Regurgitation)
arm group label: failed transcather aortic valve (Regurgitation and stenotic))
intervention type: Device
intervention name: TAVR
description: Trancatheter aortic valve replacement
arm group label: failed transcather aortic valve (Regurgitation and stenotic))
arm group label: failed transcather aortic valve (Regurgitation)
arm group label: failed transcather aortic valve (Stenotic)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Policlinico S. Donato
investigator full name: Luca Testa
investigator title: Interventional Cardiology
sharing ipd: Undecided