<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/NCT03753126</url>
  </required_header>
  <id_info>
    <org_study_id>Perceval Geometry</org_study_id>
    <nct_id>NCT03753126</nct_id>
  </id_info>
  <brief_title>Stent Geometry in Sutureless Bioprosthetic Valves</brief_title>
  <official_title>Leaflet Thickening and Stent Geometry in Sutureless Bioprosthetic Aortic Valves</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska University Hospital</source>
  <brief_summary>
    <textblock>
      A single-center prospective interventional trial. Patients implanted with a sutureless&#xD;
      bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012&#xD;
      will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be&#xD;
      performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet&#xD;
      thickening. Results of the CT examination, preoperative clinical characteristics, and&#xD;
      postoperative clinical data will be registered. Data will be collected prospectively and&#xD;
      retrospectively. Informed consent will be obtained from patients meeting the inclusion&#xD;
      criteria before the initiation of any study-specific procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Regional expansion of valve prosthesis</measure>
    <time_frame>At CT performed once no less than 30 days and up to 10 years after aortic valve replacement</time_frame>
    <description>Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall expansion of valve prosthesis</measure>
    <time_frame>At CT performed once no less than 30 days and up to 10 years after aortic valve replacement</time_frame>
    <description>Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eccentricity of valve prosthesis</measure>
    <time_frame>At CT performed once no less than 30 days and up to 10 years after aortic valve replacement</time_frame>
    <description>Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Heart Valve Diseases</condition>
  <arm_group>
    <arm_group_label>Cardiac CT imaging</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>4-dimensional volume-rendered computed tomography</intervention_name>
    <arm_group_label>Cardiac CT imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implanted with a sutureless Perceval (LivaNova) sutureless bioprosthetic aortic valve&#xD;
             at Karolinska University Hospital in Stockholm, Sweden between 2012 and 2016&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        •Contraindication for CT with intravenous contrast injection&#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_official>
    <last_name>Magnus Dalén, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 22, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska University Hospital</investigator_affiliation>
    <investigator_full_name>Magnus Dalén</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03753126
org study id: Perceval Geometry
nct id: NCT03753126
lead sponsor: 
collaborator: 
A single-center prospective interventional trial. Patients implanted with a sutureless
      bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012
      will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be
      performed. The aim of the CT is to assess valve geometry and hypo-atrenuated leaflet
      thickening. Results of the CT examination, preoperative clinical characteristics, and
      postoperative clinical data will be registered. Data will be collected prospectively and
      retrospectively. Informed consent will be obtained from patients meeting the inclusion
      criteria before the initiation of any study-specific procedures.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
measure: Regional expansion of valve prosthesis
time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
description: Regional expansion measured using the angle formed by the border of each prosthetic leaflet and the centre point of the valve
measure: Overall expansion of valve prosthesis
time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
description: Overall expansion of the implanted prosthesis calculated as the ratio between the ex vivo cross-sectional area and the in vitro cross-sectional area of the implanted valve
measure: Eccentricity of valve prosthesis
time frame: At CT performed once no less than 30 days and up to 10 years after aortic valve replacement
description: Eccentricity of the implanted prosthesis calculated as ([max diameter-min diameter]/max diameter)×100
arm group label: Cardiac CT imaging
arm group type: Other
intervention type: Radiation
intervention name: 4-dimensional volume-rendered computed tomography
arm group label: Cardiac CT imaging
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Magnus Dalén, MD PhD
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska University Hospital
investigator full name: Magnus Dalén
investigator title: MD PhD
mesh term: Aortic Valve Stenosis
mesh term: Heart Valve Diseases