<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/NCT03769545</url>
  </required_header>
  <id_info>
    <org_study_id>258843</org_study_id>
    <nct_id>NCT03769545</nct_id>
  </id_info>
  <brief_title>Mortality Post-TAVI and Correlation With Haemodynamic Parameters.</brief_title>
  <official_title>Mortality Post-TAVI and Correlation With Haemodynamic Parameters.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Until a few years ago the only interventional option available for severe aortic stenosis was&#xD;
      surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was&#xD;
      applied for the first time in humans, the transcatheter aortic valve implantation (TAVI).&#xD;
      Initially this procedure was reserved for those patients deemed too high risk for surgical&#xD;
      intervention. As technology progressed in this domain, the indication for TAVI expanded to a&#xD;
      broader population of patient with severe aortic stenosis. To-date there are no long-term&#xD;
      data for mortality and this is the central question this study will explore in correlation&#xD;
      with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the&#xD;
      long term. All patients that had a TAVI within the RBH&amp;HH NHS Foundation Trust between&#xD;
      January 2008 and December 2017 will be included in the study. This is a retrospective study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic valve stenosis is the most prevalent valvulopathy in the developed world countries.&#xD;
      Until a few years ago the only interventional option available for severe aortic stenosis was&#xD;
      surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was&#xD;
      applied for the first time in humans, the transcatheter aortic valve implantation (TAVI) as a&#xD;
      keyhole procedure. Initially this procedure was reserved for those patients deemed too high&#xD;
      risk for surgical intervention. As technology progressed in this domain, the indication for&#xD;
      TAVI expanded to a broader population of patient with severe aortic stenosis. As the&#xD;
      experience broadens there are no long-term data for mortality and this is the central&#xD;
      question this study will explore in correlation with haemodynamic parameters. Essentially,&#xD;
      this study will explore the effect of TAVI in the long term. All patients that had a TAVI&#xD;
      within the RBH&amp;HH NHS Foundation Trust between January 2008 and December 2017 will be&#xD;
      included in the study. This is a retrospective study and will not change anything in the&#xD;
      patients' standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2008</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Death post-TAVI</measure>
    <time_frame>Within 3 years from TAVI procedure</time_frame>
    <description>Death during or after TAVI</description>
  </primary_outcome>
  <enrollment type="Actual">1200</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with TAVI within the Royal Brompton &amp; Harefield NHS Foundation Trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with TAVI within the Royal Brompton &amp; Harefield NHS Foundation Trust&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Luescher</last_name>
    <role>Study Director</role>
    <affiliation>Director of Research Education and Development, Cardiology (RBH)</affiliation>
  </overall_official>
  <reference>
    <citation>Denegri A, Mehran R, Holy E, Taramasso M, Pasotti E, Pedrazzini G, Moccetti T, Maisano F, Nietlispach F, Obeid S. Post procedural risk assessment in patients undergoing trans aortic valve implantation according to the age, creatinine, and ejection fraction-7 score: Advantages of age, creatinine, and ejection fraction-7 in stratification of post-procedural outcome. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):141-148. doi: 10.1002/ccd.27806. Epub 2018 Sep 30.</citation>
    <PMID>30269398</PMID>
  </reference>
  <reference>
    <citation>Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.</citation>
    <PMID>30346515</PMID>
  </reference>
  <reference>
    <citation>Adams HSL, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. Contemporary review of severe aortic stenosis. Intern Med J. 2019 Mar;49(3):297-305. doi: 10.1111/imj.14071.</citation>
    <PMID>30091235</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Panagiotis Savvoulidis</investigator_full_name>
    <investigator_title>Clinical Fellow in Interventional Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <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/NCT03769545
org study id: 258843
nct id: NCT03769545
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Until a few years ago the only interventional option available for severe aortic stenosis was
      surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was
      applied for the first time in humans, the transcatheter aortic valve implantation (TAVI).
      Initially this procedure was reserved for those patients deemed too high risk for surgical
      intervention. As technology progressed in this domain, the indication for TAVI expanded to a
      broader population of patient with severe aortic stenosis. To-date there are no long-term
      data for mortality and this is the central question this study will explore in correlation
      with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the
      long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between
      January 2008 and December 2017 will be included in the study. This is a retrospective study.
Aortic valve stenosis is the most prevalent valvulopathy in the developed world countries.
      Until a few years ago the only interventional option available for severe aortic stenosis was
      surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was
      applied for the first time in humans, the transcatheter aortic valve implantation (TAVI) as a
      keyhole procedure. Initially this procedure was reserved for those patients deemed too high
      risk for surgical intervention. As technology progressed in this domain, the indication for
      TAVI expanded to a broader population of patient with severe aortic stenosis. As the
      experience broadens there are no long-term data for mortality and this is the central
      question this study will explore in correlation with haemodynamic parameters. Essentially,
      this study will explore the effect of TAVI in the long term. All patients that had a TAVI
      within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be
      included in the study. This is a retrospective study and will not change anything in the
      patients' standard of care.
observational model: Case-Only
time perspective: Retrospective
measure: Death post-TAVI
time frame: Within 3 years from TAVI procedure
description: Death during or after TAVI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas Luescher
role: Study Director
affiliation: Director of Research Education and Development, Cardiology (RBH)
citation: Denegri A, Mehran R, Holy E, Taramasso M, Pasotti E, Pedrazzini G, Moccetti T, Maisano F, Nietlispach F, Obeid S. Post procedural risk assessment in patients undergoing trans aortic valve implantation according to the age, creatinine, and ejection fraction-7 score: Advantages of age, creatinine, and ejection fraction-7 in stratification of post-procedural outcome. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):141-148. doi: 10.1002/ccd.27806. Epub 2018 Sep 30.
PMID: 30269398
citation: Cocchieri R, Petzina R, Romano M, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Bapat V, Baumbach H, Sims H, Deutsch C, Bramlage P, Kurucova J, Thoenes M, Frank D. Outcomes after transaortic transcatheter aortic valve implantation: long-term findings from the European ROUTEdagger. Eur J Cardiothorac Surg. 2019 Apr 1;55(4):737-743. doi: 10.1093/ejcts/ezy333.
PMID: 30346515
citation: Adams HSL, Ashokkumar S, Newcomb A, MacIsaac AI, Whitbourn RJ, Palmer S. Contemporary review of severe aortic stenosis. Intern Med J. 2019 Mar;49(3):297-305. doi: 10.1111/imj.14071.
PMID: 30091235
responsible party type: Principal Investigator
investigator affiliation: Royal Brompton & Harefield NHS Foundation Trust
investigator full name: Panagiotis Savvoulidis
investigator title: Clinical Fellow in Interventional Cardiology
mesh term: Aortic Valve Stenosis
sharing ipd: No