<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/NCT03002272</url>
  </required_header>
  <id_info>
    <org_study_id>TAVR Durability</org_study_id>
    <nct_id>NCT03002272</nct_id>
  </id_info>
  <brief_title>Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study</brief_title>
  <official_title>Transcatheter Aortic Prosthesis Function: A Long-term Follow-up Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medstar Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this observational study, the investigators will enroll subjects who underwent TAVR or&#xD;
      SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be&#xD;
      collected, alongside clinical and echocardiographic data from subsequent follow-up visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is limited available information on long term TAVR valve function. In this&#xD;
      observational study, the investigators will enroll subjects who underwent TAVR or SAVR more&#xD;
      than 3 years ago. Clinical and procedural data from the implant/surgery will be collected,&#xD;
      alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date&#xD;
      echocardiography will be performed and analyzed in a Core Lab to assess valve function&#xD;
      yearly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 20, 2018</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prosthetic valve dysfunction</measure>
    <time_frame>7 years</time_frame>
    <description>Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in functional status</measure>
    <time_frame>discharge from hospital</time_frame>
    <description>Change in functional status from baseline and discharge per NYHA classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Increase in severity of aortic regurgitation</measure>
    <time_frame>upto 7 years</time_frame>
    <description>Increase in severity of aortic regurgitation by one or more grading of severity</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Aortic Valve Replacement</condition>
  <arm_group>
    <arm_group_label>TAVR</arm_group_label>
    <description>This observational study will enroll subjects that underwent TAVR more than 3 years ago.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAVR</arm_group_label>
    <description>Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR</intervention_name>
    <description>subjects that underwent TAVR more than 3 years ago</description>
    <arm_group_label>TAVR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SAVR</intervention_name>
    <description>Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago</description>
    <arm_group_label>SAVR</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This observational study will enroll subjects that underwent TAVR more than 3 years ago.&#xD;
        TAVR.&#xD;
&#xD;
        Historical controls will be selected from among patients at the same site who underwent&#xD;
        isolated bioprosthetic SAVR more than 3 years ago&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for TAVR subjects&#xD;
&#xD;
        a) TAVR performed more than 3 years ago&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Subjects unable to consent to participate, unless the subject has a legally authorized&#xD;
             representative&#xD;
&#xD;
          2. Subjects unwilling to participate&#xD;
&#xD;
          3. Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure&#xD;
             (e.g. balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure)&#xD;
&#xD;
          4. Echocardiographic evidence of prosthetic valve dysfunction within first 3 years&#xD;
             post-TAVR (mean aortic gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic&#xD;
             regurgitation)&#xD;
&#xD;
        Inclusion criteria for SAVR subjects&#xD;
&#xD;
          1. SAVR performed more than 3 years ago&#xD;
&#xD;
          2. Propensity matched to an enrolled TAVR subject&#xD;
&#xD;
        Exclusion criteria for SAVR subjects e) Subjects unable to consent to participate, unless&#xD;
        the subject has a legally authorized representative f) Subjects unwilling to participate g)&#xD;
        Subject has undergone re-intervention to prosthetic aortic valve since TAVR procedure (e.g.&#xD;
        balloon valvuloplasty, SAVR, re-do TAVR, paravalvular leak closure) h) Echocardiographic&#xD;
        evidence of prosthetic valve dysfunction within first 3 years post-SAVR (mean aortic&#xD;
        gradient ≥20mmHg AND/OR moderate-severe transvalvular aortic regurgitation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Megan Rowland, MPH</last_name>
    <phone>202-877-2959</phone>
    <email>megan.e.rowland@medstar.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Rowland</last_name>
      <phone>202-877-2959</phone>
      <email>megan.e.rowland@medstar.net</email>
    </contact>
    <investigator>
      <last_name>Ron Waksman, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03002272
org study id: TAVR Durability
nct id: NCT03002272
lead sponsor: 
has dmc: No
In this observational study, the investigators will enroll subjects who underwent TAVR or
      SAVR more than 3 years ago. Clinical and procedural data from the implant/surgery will be
      collected, alongside clinical and echocardiographic data from subsequent follow-up visits.
There is limited available information on long term TAVR valve function. In this
      observational study, the investigators will enroll subjects who underwent TAVR or SAVR more
      than 3 years ago. Clinical and procedural data from the implant/surgery will be collected,
      alongside clinical and echocardiographic data from subsequent follow-up visits. Up-to-date
      echocardiography will be performed and analyzed in a Core Lab to assess valve function
      yearly.
observational model: Case-Control
time perspective: Other
measure: Prosthetic valve dysfunction
time frame: 7 years
description: Mean aortic valve gradient ≥20 mm Hg Moderate-severe transvalvular aortic regurgitation
measure: Change in functional status
time frame: discharge from hospital
description: Change in functional status from baseline and discharge per NYHA classification
measure: Increase in severity of aortic regurgitation
time frame: upto 7 years
description: Increase in severity of aortic regurgitation by one or more grading of severity
arm group label: TAVR
description: This observational study will enroll subjects that underwent TAVR more than 3 years ago.
arm group label: SAVR
description: Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
intervention type: Device
intervention name: TAVR
description: subjects that underwent TAVR more than 3 years ago
arm group label: TAVR
intervention type: Device
intervention name: SAVR
description: Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
arm group label: SAVR
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Megan Rowland, MPH
phone: 202-877-2959
email: megan.e.rowland@medstar.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No