<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/NCT02209298</url>
  </required_header>
  <id_info>
    <org_study_id>MED-02</org_study_id>
    <nct_id>NCT02209298</nct_id>
  </id_info>
  <brief_title>CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.</brief_title>
  <official_title>Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study is intended to collect real-world (post-approval use) data regarding&#xD;
      the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter&#xD;
      Aortic Valve Implantation (TAVI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To collect real-world (post-approval use) data regarding the clinical utility and performance&#xD;
      of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic&#xD;
      bioprosthesis who are at high risk for redo surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">December 3, 2018</completion_date>
  <primary_completion_date type="Actual">November 2017</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>Cardiovascular death</measure>
    <time_frame>30 days post-index procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lack of significant aortic stenosis or insufficiency</measure>
    <time_frame>1 year Follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety composite endpoint based on VARC-II endpoint definitions</measure>
    <time_frame>At 30 days and during follow-up visits</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient</measure>
    <time_frame>At 30 days and during follow-up visits</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">202</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>CoreValve Transcatheter Valve</arm_group_label>
    <description>Medtronic CoreValve SystemTM is designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve. The support frame is manufactured by Nitinol, which has multi-level, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from a single layer of porcine pericardium into a tri-leaflet configuration. The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound derived from oleic acid, a naturally occurring long-chain fatty acid. AOA™ is an antimineralization treatment shown to reduce both early and late valvular calcification.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoreValve Transcatheter Valve</intervention_name>
    <description>Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.</description>
    <arm_group_label>CoreValve Transcatheter Valve</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be screened from symptomatic high risk adult patients candidates for an&#xD;
        intervention on degenerative surgical aortic bioprosthesis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is &gt; 18 years old&#xD;
&#xD;
          -  Patient has a symptomatic degeneration of aortic bioprosthesis&#xD;
&#xD;
          -  Acceptable candidate for elective treatment with the Medtronic CoreValveTM System&#xD;
             (according to the most recent version of the Medtronic CoreValveTM Instructions For&#xD;
             Use) and in conformity with the local regulatory and reimbursement context&#xD;
&#xD;
          -  Logistical Euroscore &gt; 20% or STS &gt; 10% or presence of comorbidities responsible of&#xD;
             contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or&#xD;
             patients in whom heart team has assessed the redo surgery at high risk&#xD;
&#xD;
          -  The patient or legal representative has been informed of the nature of the procedure&#xD;
             and the study and has consented to participate, and has authorized the collection and&#xD;
             release of his/her medical information by signing a consent form (&quot;Patient Informed&#xD;
             Consent Form&quot;)&#xD;
&#xD;
          -  The patient is willing and able to comply with requirements of the study, including&#xD;
             the 24 months follow-up&#xD;
&#xD;
          -  Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated&#xD;
&#xD;
          -  Patient in whom heart team considers that risk of TAVI is too high with a particular&#xD;
             attention for the risk of coronary occlusion&#xD;
&#xD;
          -  Patient with prior endocarditis on failed bioprosthesis&#xD;
&#xD;
          -  Patient has other medical illness associated with a limited life expectancy (i.e.,&#xD;
             less than 1 year)&#xD;
&#xD;
          -  Patient with LVEF &lt;20%, cardiogenic shock, or hemodynamic compromise requiring&#xD;
             pressors or inotropes or mechanical support devices&#xD;
&#xD;
          -  Patient with severe mitral disease associated with severe pulmonary hypertension&#xD;
&#xD;
          -  Acute coronary syndrome less than 7 days before intervention&#xD;
&#xD;
          -  Currently participating in another investigational drug or device study.&#xD;
&#xD;
          -  Patient with significant paravalvular regurgitation&#xD;
&#xD;
          -  Patient in whom internal diameter prosthesis is equal to 17 mm&#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>Didier Tchetche, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Pasteur Toulouse</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jean-Philippe Verhoye, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire, Rennes</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ran Kornowski, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center, Tel Aviv</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Clermont</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Mondor</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Parly 2 Le Chesnay</name>
      <address>
        <city>Le Chesnay</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL CHU Louis Pradel</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Timone</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Pessac</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rangueil Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tonkin Clinic</name>
      <address>
        <city>Villeurbanne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Diabeteszentrum NRW</name>
      <address>
        <city>Bad Oeynhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana-Herzzentrum Cottbus</name>
      <address>
        <city>Cottbus</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamburg Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig GmbH Leipzig</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical center</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brescia Hospital</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Donato</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Pisana</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 15, 2019</last_update_submitted>
  <last_update_submitted_qc>April 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</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/NCT02209298
org study id: MED-02
nct id: NCT02209298
lead sponsor: 
has dmc: Yes
This observational study is intended to collect real-world (post-approval use) data regarding
      the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter
      Aortic Valve Implantation (TAVI).
To collect real-world (post-approval use) data regarding the clinical utility and performance
      of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic
      bioprosthesis who are at high risk for redo surgery.
observational model: Cohort
time perspective: Prospective
measure: Cardiovascular death
time frame: 30 days post-index procedure
measure: Lack of significant aortic stenosis or insufficiency
time frame: 1 year Follow-up
measure: Safety composite endpoint based on VARC-II endpoint definitions
time frame: At 30 days and during follow-up visits
measure: Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient
time frame: At 30 days and during follow-up visits
arm group label: CoreValve Transcatheter Valve
description: Medtronic CoreValve SystemTM is designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve. The support frame is manufactured by Nitinol, which has multi-level, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from a single layer of porcine pericardium into a tri-leaflet configuration. The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound derived from oleic acid, a naturally occurring long-chain fatty acid. AOA™ is an antimineralization treatment shown to reduce both early and late valvular calcification.
intervention type: Device
intervention name: CoreValve Transcatheter Valve
description: Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.
arm group label: CoreValve Transcatheter Valve
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Didier Tchetche, Dr.
role: Principal Investigator
affiliation: Clinique Pasteur Toulouse
last name: Jean-Philippe Verhoye, Prof.
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire, Rennes
last name: Ran Kornowski, Prof.
role: Principal Investigator
affiliation: Rabin Medical Center, Tel Aviv
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country: France
country: Germany
country: Israel
country: Italy
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis