<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/NCT01720342</url>
  </required_header>
  <id_info>
    <org_study_id>EASE Enable</org_study_id>
    <nct_id>NCT01720342</nct_id>
  </id_info>
  <brief_title>Enable® Aortic Sutureless Bioprosthesis Evaluation</brief_title>
  <acronym>EASE</acronym>
  <official_title>Enable® Aortic Sutureless Bioprosthesis Evaluation: A Post-market Release Non-interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiovascular</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The EASE Enable study is intended to collect additional data on the clinical outcomes of the&#xD;
      Medtronic Enable® Aortic Bioprosthesis in &quot;real world&quot; patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EASE Enable study is intended to characterize the clinical performance of the Medtronic&#xD;
      Enable® aortic bioprosthesis in a post-market real-world setting.&#xD;
&#xD;
      This is a Non-randomized, prospective, non-interventional multi-center post-market release&#xD;
      (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic&#xD;
      valve replacement with the Enable® aortic bioprosthesis, each patient will have routine&#xD;
      follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant&#xD;
      or prior to hospital discharge, whatever comes first), within 6 months following&#xD;
      implantation, 1 year and annually thereafter up to 5 years post-implant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.</measure>
    <time_frame>During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.</time_frame>
    <description>The early and late (up to five years) clinical performance of the Enable® aortic bioprosthesis will be characterized. Measures of clinical performance will include hemodynamic performance by echocardiography, New York Heart Association (NYHA) Functional Classification and safety (SAEs, ADEs, SADEs).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">225</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Aortic Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Aortic valve stenosis, aortic valve insufficiency</arm_group_label>
    <description>Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aortic Valve Replacement surgery</intervention_name>
    <description>Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.</description>
    <arm_group_label>Aortic valve stenosis, aortic valve insufficiency</arm_group_label>
    <other_name>Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with aortic valve stenosis, aortic valve insufficiency or a combination of the two&#xD;
        who require aortic valve replacement are eligible for this study, if they meet all study&#xD;
        inclusion criteria and none of the exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with aortic valve stenosis, aortic valve insufficiency or a combination of the&#xD;
             two.&#xD;
&#xD;
          -  Patient requires replacement of his/her native aortic valve with a bioprosthesis with&#xD;
             or without concomitant procedures.&#xD;
&#xD;
          -  Patient is above the minimum age as required by local regulations to be participating&#xD;
             in a clinical study.&#xD;
&#xD;
          -  Patient is willing to return to the implant site for follow-up visits.&#xD;
&#xD;
          -  Patient has been adequately informed of this clinical study and is willing to sign the&#xD;
             patient Data Release Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient requires replacement of two or more valves.&#xD;
&#xD;
          -  Patient who underwent previous aortic valve replacement (AVR).&#xD;
&#xD;
          -  Patient with native bicuspid aortic valve.&#xD;
&#xD;
          -  Patient with active endocarditis or other systemic infection.&#xD;
&#xD;
          -  Patient dilatation of the ascending aorta, deformations or irregular aortic annulus or&#xD;
             ascending aorta geometry as seen via preoperative imaging.&#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>Otto Dapunt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LKH Universitätsklinik Graz, Austria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Régional Universitaire de Lille (CHRU)</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint-Etienne Hôpital Nord</name>
      <address>
        <city>Saint-Etienne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf (UKD)</name>
      <address>
        <city>Duesseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover (MHH)</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deutssches Herzzentrum Muenchen</name>
      <address>
        <city>Munich</city>
        <zip>80636</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster (UKM)</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg GmbH</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa Di Cura Privata 'Montevergine' S.p.A.</name>
      <address>
        <city>Mercogliano</city>
        <zip>83013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Luigi Sacco</name>
      <address>
        <city>Milan</city>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Complesso Ospedaliero S.Filippo Neri</name>
      <address>
        <city>Rome</city>
        <zip>00135</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leids Universitair Medisch Centrum</name>
      <address>
        <city>Leiden</city>
        <zip>2300 RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospiten Rambla</name>
      <address>
        <city>Santa Cruz de Tenerife</city>
        <zip>38001</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.</citation>
    <PMID>21342776</PMID>
  </reference>
  <reference>
    <citation>Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.</citation>
    <PMID>24787699</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medtronic Enable® aortic bioprosthesis</keyword>
  <keyword>Aortic valve stenosis</keyword>
  <keyword>Aortic valve insufficiency</keyword>
  <keyword>&quot;Real world&quot; patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Aortic Valve Insufficiency</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/NCT01720342
org study id: EASE Enable
nct id: NCT01720342
lead sponsor: 
has dmc: No
The EASE Enable study is intended to collect additional data on the clinical outcomes of the
      Medtronic Enable® Aortic Bioprosthesis in "real world" patients.
The EASE Enable study is intended to characterize the clinical performance of the Medtronic
      Enable® aortic bioprosthesis in a post-market real-world setting.

      This is a Non-randomized, prospective, non-interventional multi-center post-market release
      (PMR) study. Up to 800 subjects will be enrolled at up to 40 centers in Europe. After aortic
      valve replacement with the Enable® aortic bioprosthesis, each patient will have routine
      follow-up visits at the following intervals: at 30 days post-implant (at 30 days post-implant
      or prior to hospital discharge, whatever comes first), within 6 months following
      implantation, 1 year and annually thereafter up to 5 years post-implant.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Clinical performance during implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.
time frame: During implant procedure, at 30 days post-implant (or prior to hospital discharge, whatever comes first), within 6 months post-operation, 1 year and annually thereafter up to 5 years post-procedure.
description: The early and late (up to five years) clinical performance of the Enable® aortic bioprosthesis will be characterized. Measures of clinical performance will include hemodynamic performance by echocardiography, New York Heart Association (NYHA) Functional Classification and safety (SAEs, ADEs, SADEs).
arm group label: Aortic valve stenosis, aortic valve insufficiency
description: Patients with aortic valve insufficiency and/or aortic valve stenosis who require AVR.
intervention type: Procedure
intervention name: Aortic Valve Replacement surgery
description: Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
arm group label: Aortic valve stenosis, aortic valve insufficiency
other name: Medtronic ATS 3f Enable® Aortic Bioprosthesis (Model 6000)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Otto Dapunt, MD
role: Principal Investigator
affiliation: LKH Universitätsklinik Graz, Austria
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
citation: Martens S, Sadowski J, Eckstein FS, Bartus K, Kapelak B, Sievers HH, Schlensak C, Carrel T. Clinical experience with the ATS 3f Enable(R) Sutureless Bioprosthesis. Eur J Cardiothorac Surg. 2011 Sep;40(3):749-55. doi: 10.1016/j.ejcts.2010.12.068. Epub 2011 Feb 20.
PMID: 21342776
citation: Englberger L, Carrel TP, Doss M, Sadowski J, Bartus K, Eckstein FF, Asch FM, Martens S. Clinical performance of a sutureless aortic bioprosthesis: five-year results of the 3f Enable long-term follow-up study. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1681-7. doi: 10.1016/j.jtcvs.2014.03.054. Epub 2014 Apr 4.
PMID: 24787699
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Insufficiency