<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/NCT03752866</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-CL1003491</org_study_id>
    <nct_id>NCT03752866</nct_id>
  </id_info>
  <brief_title>The CONFIDENCE Registry</brief_title>
  <official_title>CONtrolled Delivery For ImproveD outcomEs With cliNiCal Evidence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this clinical investigation is to characterize the procedural safety and&#xD;
      device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart&#xD;
      Valve in patients with symptomatic degenerative aortic stenosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The CONFIDENCE registry study will be conducting as a prospective, non-randomized,&#xD;
      observational, single-arm, multi-center study.&#xD;
&#xD;
      Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS),&#xD;
      will undergo Portico™ Transcatheter Aortic Heart Valve implantation.&#xD;
&#xD;
      The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and&#xD;
      12 months from the index procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 25, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">November 2, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiovascular Mortality</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stroke (including disabling and non-disabling)</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding (life-threatening, major, minor)</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Acute kidney injury</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vascular access site and access-related complications (major and minor)</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Annular rupture</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Conversion to open surgery</measure>
    <time_frame>30 days from the index procedure</time_frame>
    <description>VARC-2 definition of conversion to open surgery: Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications</description>
  </other_outcome>
  <other_outcome>
    <measure>Coronary obstruction</measure>
    <time_frame>30 days from the index procedure</time_frame>
    <description>As per VARC-2 criteria: Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Valve embolization</measure>
    <time_frame>30 days from the index procedure</time_frame>
    <description>As per VARC-2 criteria: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus</description>
  </other_outcome>
  <other_outcome>
    <measure>Transcatheter valve-in-valve deployment</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Permanent pacemaker insertion</measure>
    <time_frame>30 days from the index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Delivery profile characteristics</measure>
    <time_frame>At 30 days post index procedure</time_frame>
    <description>Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size</description>
  </other_outcome>
  <other_outcome>
    <measure>Implant success</measure>
    <time_frame>At 30 days post index procedure</time_frame>
    <description>Implant success defined as:&#xD;
Absence of procedural mortality&#xD;
Correct positioning of a single Portico prosthetic heart valve into the proper anatomical location</description>
  </other_outcome>
  <other_outcome>
    <measure>Echocardiographic assessment of hemodynamic valve performance</measure>
    <time_frame>At 30 days post index procedure</time_frame>
    <description>Echocardiographic assessment of hemodynamic valve performance include:&#xD;
Mean gradient&#xD;
Effective orifice area&#xD;
Paravalvular leak (PVL)</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical improvement from baseline</measure>
    <time_frame>At 30 days post index procedure</time_frame>
    <description>Clinical improvement from baseline assessed by:&#xD;
New York Heart Association (NYHA) functional class change from Baseline to 30 days&#xD;
Quality of Life (QoL) questionnaire (EQ5D-3L) changes from baseline to 30 days</description>
  </other_outcome>
  <other_outcome>
    <measure>All-cause mortality All-cause mortality All-cause mortality</measure>
    <time_frame>At 30 days post index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>At 12 months post index procedure</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1001</enrollment>
  <condition>Symptomatic Degenerative Aortic Stenosis</condition>
  <condition>Severe Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Portico™ Valve, Delivery System(s) and Loading Systems(s)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Portico™ Valve, FlexNav Delivery and Loading System(s)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)</intervention_name>
    <description>Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system</description>
    <arm_group_label>Portico™ Valve, Delivery System(s) and Loading Systems(s)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)</intervention_name>
    <description>Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems</description>
    <arm_group_label>Portico™ Valve, FlexNav Delivery and Loading System(s)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are &gt;18 years of age or legal age in host country and have been&#xD;
             identified as a candidate for a Portico™ valve implant&#xD;
&#xD;
          -  Subjects who have been informed of the nature of the study, agree to its provisions&#xD;
             and have provided written informed consent as approved by the Ethics Committee (EC) of&#xD;
             the respective clinical center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Candidates will be excluded if any of the following conditions are present:&#xD;
&#xD;
          1. Have sepsis, including active endocarditis&#xD;
&#xD;
          2. Have any evidence of left ventricular or atrial thrombus&#xD;
&#xD;
          3. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification)&#xD;
             that make insertion and endovascular access to the aortic valve improbable&#xD;
&#xD;
          4. Have a non-calcified aortic annulus&#xD;
&#xD;
          5. Have congenital bicuspid or unicuspid leaflet configuration&#xD;
&#xD;
          6. Are unable to tolerate antiplatelet/anticoagulant therapy&#xD;
&#xD;
          7. Are pregnant at the time of signing informed consent&#xD;
&#xD;
          8. Are currently participating in a drug or device study that may impact the registry&#xD;
             (unless prior sponsor approval for co-enrollment is granted)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helge Möllmann</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Johannes Hospital, Dortmund, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Care Partners- Wesley Hospital</name>
      <address>
        <city>Woolloongabba</city>
        <state>Queensland</state>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>77900</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken der Friedrich-Alexander-Universitat</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerckhoff-Klinik gGmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite Campus Virchow Klinikum</name>
      <address>
        <city>Berlin-Mitte</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Berlin - Charité Campus Mitte (CCM)</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Berlin - Campus Benjamin Franklin (CBF)</name>
      <address>
        <city>Berlin</city>
        <zip>12203</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.-Johannes-Hospital</name>
      <address>
        <city>Dortmund</city>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Dresden GmbH Universitätsklinik</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Johann Wolfgang Goethe-Universität Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKE Hamburg (Universitatsklinik Eppendorf)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städtisches Klinikum Karlsruhe gGmbH Medizinischen Klinik IV</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin der Johannes Gutenberg-Universität Mainz</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico di Monza</name>
      <address>
        <city>Monza</city>
        <state>Lombardy</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Bortolo</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Centralny Szpital Kliniczny</name>
      <address>
        <city>Warsaw</city>
        <state>Mazovia</state>
        <zip>02-097</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <state>Catalonia</state>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Juan Ramon Jimenez</name>
      <address>
        <city>Huelva</city>
        <zip>21005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Aarau</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Belfast</city>
        <state>Ireland</state>
        <zip>BT12 6BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook University Hoospital</name>
      <address>
        <city>Middlesbrough</city>
        <state>North East England</state>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morriston Hospital - ABM University Health Board</name>
      <address>
        <city>Morriston</city>
        <state>Swansea</state>
        <zip>SA6 6NL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>January 14, 2022</last_update_submitted>
  <last_update_submitted_qc>January 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Portico™ valve</keyword>
  <keyword>Portico™ valve delivery system</keyword>
  <keyword>Portico™ valve loading system</keyword>
  <keyword>Transcatheter Aortic Valve Replacement</keyword>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Heart Valve Prosthesis</keyword>
  <keyword>TAVR</keyword>
  <keyword>TAVR Registry</keyword>
  <keyword>Transcatheter Aortic Valve Implant</keyword>
  <keyword>TAVI</keyword>
  <keyword>TAVI Registry</keyword>
  <keyword>FlexNav delivery system</keyword>
  <keyword>FlexNav loading system</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>
  <!-- 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/NCT03752866
org study id: SJM-CIP-CL1003491
nct id: NCT03752866
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this clinical investigation is to characterize the procedural safety and
      device performance of transfemoral implantation of the Portico™ Transcatheter Aortic Heart
      Valve in patients with symptomatic degenerative aortic stenosis.
The CONFIDENCE registry study will be conducting as a prospective, non-randomized,
      observational, single-arm, multi-center study.

      Approximately 1000 subjects with severe symptomatic (NYHA class ≥ II) aortic stenosis (AS),
      will undergo Portico™ Transcatheter Aortic Heart Valve implantation.

      The subject data will be collected at baseline, index procedure, pre- discharge, 30 days and
      12 months from the index procedure.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This registry will include market released Portico™ valves (23mm, 25mm, 27mm and 29mm), delivery systems and loading systems. The registry will also allow future iterations of the Portico valve and delivery system along with expanded indications to be included as they receive approval for commercial use in the country where the subject is enrolled.
primary purpose: Treatment
masking: None (Open Label)
measure: Cardiovascular Mortality
time frame: 30 days from the index procedure
measure: Myocardial Infarction
time frame: 30 days from the index procedure
measure: Stroke (including disabling and non-disabling)
time frame: 30 days from the index procedure
measure: Bleeding (life-threatening, major, minor)
time frame: 30 days from the index procedure
measure: Acute kidney injury
time frame: 30 days from the index procedure
measure: Vascular access site and access-related complications (major and minor)
time frame: 30 days from the index procedure
measure: Annular rupture
time frame: 30 days from the index procedure
measure: Conversion to open surgery
time frame: 30 days from the index procedure
description: VARC-2 definition of conversion to open surgery: Conversion to open sternotomy during the TAVI procedure secondary to any procedure-related complications
measure: Coronary obstruction
time frame: 30 days from the index procedure
description: As per VARC-2 criteria: Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the valve prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure
measure: Valve embolization
time frame: 30 days from the index procedure
description: As per VARC-2 criteria: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus
measure: Transcatheter valve-in-valve deployment
time frame: 30 days from the index procedure
measure: Permanent pacemaker insertion
time frame: 30 days from the index procedure
measure: Delivery profile characteristics
time frame: At 30 days post index procedure
description: Delivery profile characteristics assess access vessel diameter, sheath utilization and sheath size
measure: Implant success
time frame: At 30 days post index procedure
description: Implant success defined as:
Absence of procedural mortality
Correct positioning of a single Portico prosthetic heart valve into the proper anatomical location
measure: Echocardiographic assessment of hemodynamic valve performance
time frame: At 30 days post index procedure
description: Echocardiographic assessment of hemodynamic valve performance include:
Mean gradient
Effective orifice area
Paravalvular leak (PVL)
measure: Clinical improvement from baseline
time frame: At 30 days post index procedure
description: Clinical improvement from baseline assessed by:
New York Heart Association (NYHA) functional class change from Baseline to 30 days
Quality of Life (QoL) questionnaire (EQ5D-3L) changes from baseline to 30 days
measure: All-cause mortality All-cause mortality All-cause mortality
time frame: At 30 days post index procedure
measure: All-cause mortality
time frame: At 12 months post index procedure
arm group label: Portico™ Valve, Delivery System(s) and Loading Systems(s)
arm group type: Experimental
description: Implantation of the Portico ™ Valve using the Portico Delivery and Loading Systems
arm group label: Portico™ Valve, FlexNav Delivery and Loading System(s)
arm group type: Experimental
description: Implantation of the Portico ™ Valve using the FlexNav Delivery and Loading Systems
intervention type: Device
intervention name: Portico™ Valve, Portico Delivery System(s) and Loading Systems(s)
description: Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the Portico TAVI system
arm group label: Portico™ Valve, Delivery System(s) and Loading Systems(s)
intervention type: Device
intervention name: Portico™ Valve, FlexNav Delivery System(s) and Loading Systems(s)
description: Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve using the FlexNav Delivery and Loading Systems
arm group label: Portico™ Valve, FlexNav Delivery and Loading System(s)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Helge Möllmann
role: Principal Investigator
affiliation: St. Johannes Hospital, Dortmund, Germany
facility: 
facility: 
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country: Australia
country: Belgium
country: Czechia
country: Germany
country: Italy
country: Poland
country: Spain
country: Switzerland
country: United Kingdom
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic