<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/NCT04417829</url>
  </required_header>
  <id_info>
    <org_study_id>2019/33814/REK vest</org_study_id>
    <nct_id>NCT04417829</nct_id>
  </id_info>
  <brief_title>Transcatheter Aortic Valve Implantation in Western NORway</brief_title>
  <acronym>TAVI-NOR</acronym>
  <official_title>The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</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>
      A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who&#xD;
      underwent TAVI at the Haukeland university hospital, Bergen, Norway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who&#xD;
      underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and&#xD;
      July 2019.&#xD;
&#xD;
      Demographics, clinical data including cardiovascular risk factors, arterial and&#xD;
      echocardiographic parameters were prospectively collected. The data on all-cause mortality&#xD;
      will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at&#xD;
      6-12 months follow-up) will be analyzed. The main scientific objectives are:&#xD;
&#xD;
      To assess survival benefits of TAVI according to baseline risk profile. To determine the&#xD;
      echocardiographic predictors of left ventricular mass regression and left ventricular&#xD;
      function recovery.&#xD;
&#xD;
      To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the&#xD;
      impact of various types of blood pressure responses immediately after TAVI on clinical&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</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>10 Years</target_duration>
  <primary_outcome>
    <measure>The impact of TAVI on all-cause mortality</measure>
    <time_frame>From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)</time_frame>
    <description>To assess the long-term survival benefits of TAVI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The impact of TAVI on left ventriclar mass and hypertrophy regression</measure>
    <time_frame>From January 2012 to follow-up echo (6-12 months following TAVI)</time_frame>
    <description>To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The impact of TAVI on left ventricular function recovery</measure>
    <time_frame>From January 2012 to to follow-up echo (6-12 months following TAVI)</time_frame>
    <description>To assess improvement in systolic function (increase in ejection fraction) following TAVI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).</measure>
    <time_frame>From January 2012 to to follow-up echo (6-12 months following TAVI)</time_frame>
    <description>To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">600</enrollment>
  <condition>Aortic Stenosis</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Only one arm (intervention=TAVI)</arm_group_label>
    <description>There is not control group/arm for comparison.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biological prosthesis in the aortic valve</intervention_name>
    <description>Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)</description>
    <arm_group_label>Only one arm (intervention=TAVI)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        600 patients with moderate or severe aortic stenosis of any etiology, and symptoms, where&#xD;
        aortic valve intervention was clinially indicated. All patients underwent a successful TAVI&#xD;
        (transcatheter aortic valve implantation).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hemodynamically severe aortic stenosis and symptoms&#xD;
&#xD;
          2. A decision of TAVI by Heart team&#xD;
&#xD;
          3. Patients undergoing TAVI (transcatheter aortic valve implantation)&#xD;
&#xD;
          4. Life expectancy &gt; 1-2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sever frailty&#xD;
&#xD;
          2. Severly reduced cognitive function&#xD;
&#xD;
          3. Multiple comorbid conditions&#xD;
&#xD;
          4. Technically not suited for TAVI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Sahrai Saeed, MD.Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Heart Disease Haukeland University Hospital, Begen, Norway</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic stenosis</keyword>
  <keyword>Echocardiography</keyword>
  <keyword>Transcutaneous aortic valve implantation</keyword>
  <keyword>Left ventricular dysfunction</keyword>
  <keyword>Left ventricular hypertrophy</keyword>
  <keyword>Mortality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers</ipd_description>
  </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/NCT04417829
org study id: 2019/33814/REK vest
nct id: NCT04417829
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who
      underwent TAVI at the Haukeland university hospital, Bergen, Norway.
A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who
      underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and
      July 2019.

      Demographics, clinical data including cardiovascular risk factors, arterial and
      echocardiographic parameters were prospectively collected. The data on all-cause mortality
      will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at
      6-12 months follow-up) will be analyzed. The main scientific objectives are:

      To assess survival benefits of TAVI according to baseline risk profile. To determine the
      echocardiographic predictors of left ventricular mass regression and left ventricular
      function recovery.

      To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the
      impact of various types of blood pressure responses immediately after TAVI on clinical
      outcomes.
observational model: Cohort
time perspective: Prospective
measure: The impact of TAVI on all-cause mortality
time frame: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
description: To assess the long-term survival benefits of TAVI
measure: The impact of TAVI on left ventriclar mass and hypertrophy regression
time frame: From January 2012 to follow-up echo (6-12 months following TAVI)
description: To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).
measure: The impact of TAVI on left ventricular function recovery
time frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
description: To assess improvement in systolic function (increase in ejection fraction) following TAVI
measure: The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
time frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
description: To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.
arm group label: Only one arm (intervention=TAVI)
description: There is not control group/arm for comparison.
intervention type: Device
intervention name: Biological prosthesis in the aortic valve
description: Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)
arm group label: Only one arm (intervention=TAVI)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Sahrai Saeed, MD.Ph.D.
role: Principal Investigator
affiliation: Department of Heart Disease Haukeland University Hospital, Begen, Norway
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers