<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/NCT02987894</url>
  </required_header>
  <id_info>
    <org_study_id>2016-02</org_study_id>
    <nct_id>NCT02987894</nct_id>
  </id_info>
  <brief_title>PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry</brief_title>
  <acronym>PROGRESS</acronym>
  <official_title>Prospective Observation of Aortic Regurgitation After TAVI and Progress Over Time: PROGRESS PVL Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Symetis SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</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 post-market registry is to collect and monitor ongoing safety and&#xD;
      performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™&#xD;
      Transferral Delivery System, when used as per IFU.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this post-market registry is to further evaluate the safety and&#xD;
      performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery&#xD;
      System in 500 consented patients with severe aortic stenosis and treated according to the&#xD;
      instructions for use (IFU).&#xD;
&#xD;
      Examinations to evaluate the aortic valve regurgitation performed as standard of care in&#xD;
      patients undergoing transcatheter aortic valve replacement will be analyzed by an external&#xD;
      Core Laboratory. These examinations are limited to echocardiography and/or contrast&#xD;
      aortography assessments.&#xD;
&#xD;
      The secondary objective is to collect adverse events and evaluate them according to the&#xD;
      VARC-2 consensus document.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 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>1 Year</target_duration>
  <primary_outcome>
    <measure>Change in total aortic regurgitation over time.</measure>
    <time_frame>post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure</time_frame>
    <description>total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of all-cause mortality</measure>
    <time_frame>30 days post-index procedure</time_frame>
    <description>Incidence of all-cause mortality at 30 days post index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical events as defined per VARC-2 consensus document (VARC-2)</measure>
    <time_frame>Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure</time_frame>
    <description>Clinical events as defined per VARC-2 consensus document</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with procedural success according to VARC II criteria</measure>
    <time_frame>at index- Procedure</time_frame>
    <description>Procedural success is defined as&#xD;
Absence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:&#xD;
inability to properly seat the valve in the annulus&#xD;
need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)&#xD;
surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with device success</measure>
    <time_frame>7-days post-index procedure or discharge (whichever occurs first)</time_frame>
    <description>Device success is defined as:&#xD;
Absence of intra-procedure mortality (procedure to 24H) AND,&#xD;
Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,&#xD;
Intended performance of the prosthetic heart valve:&#xD;
No prosthesis-patient mismatch (EAOi &gt;0.85 cm2/m2) AND,&#xD;
Mean aortic valve gradient &lt;20mmHg or peak velocity &lt; 3 m/s AND,&#xD;
No moderate or severe prosthetic valve regurgitation.&#xD;
In evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events assessed by VARC-2 Composite Safety</measure>
    <time_frame>30 days post-index procedure</time_frame>
    <description>VARC-2 Composite Safety at 30 days defined as:&#xD;
All-cause mortality&#xD;
All stroke (disabling and non-disabling)&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)&#xD;
Coronary artery obstruction requiring intervention&#xD;
Major vascular complication&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional improvement</measure>
    <time_frame>7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure</time_frame>
    <description>Functional improvement from baseline as per NYHA Functional Classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic function improvement from baseline</measure>
    <time_frame>7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure</time_frame>
    <description>Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Valve related dysfunction</measure>
    <time_frame>7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure</time_frame>
    <description>Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI&lt; 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript)</description>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Aortic Stenosis</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ACURATE neo™ Aortic Bioprosthesis</intervention_name>
    <description>TAVI, transcatheter aortic valve replacement. Transfemoral access.</description>
    <other_name>ACURATE TF™ Transfemoral Delivery System</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients eligible for transcatheter treatment of severe aortic stenosis with the&#xD;
        ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System according to&#xD;
        the indication in the Instruction for Use.&#xD;
&#xD;
        The ACURATE neo™ Aortic Bioprosthesis and its Delivery System are indicated for use in&#xD;
        patients 75 years of age and older with severe aortic stenosis (mean aortic gradient &gt; 40&#xD;
        mmHg or peak jet velocity &gt; 4.0 m/s or aortic valve area &lt; 1.0 cm2) for whom conventional&#xD;
        surgical aortic valve replacement is considered high risk for mortality or who are not&#xD;
        operable as determined either by a heart team consisting of a cardiologist and surgeon or&#xD;
        by the following risk assessments:&#xD;
&#xD;
        Logistic EuroSCORE &gt; 20%&#xD;
&#xD;
        STS score &gt; 10%&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is included in the registry if eligible for transcatheter treatment of severe&#xD;
             aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™&#xD;
             Transfemoral Delivery System as per the Instructions for Use (Patients which are&#xD;
             included but treated outside of the approved indication will be followed for safety&#xD;
             reasons).&#xD;
&#xD;
          2. Patient is willing to participate in the study, provides signed Informed Consent/Data&#xD;
             Authorization Form and authorizes the sharing of data in the registry. Patient agrees&#xD;
             that anonymized imaging data will be sent to and analyzed by an external Core&#xD;
             Laboratory.&#xD;
&#xD;
          3. The treating physician should ensure the subject will return for all required post&#xD;
             procedure follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Patients are excluded from the registry if they are not eligible for transcatheter&#xD;
        treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE&#xD;
        TF™ Transfemoral Delivery System as per the Instructions For Use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Won-Keun Kim, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff-Klinik Forschungsgesellschaft mbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre, University Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Paul's Hospital, Porvidence Health Care Institute</name>
      <address>
        <city>Vancouver</city>
        <zip>BC V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Augsburg</name>
      <address>
        <city>Augsburg</city>
        <zip>86156</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralklinik Bad Berka</name>
      <address>
        <city>Bad Berka</city>
        <zip>99437</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kerkhoff Kilnik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immanuel Hospital Bernau- Herzzentrum Brandenburg</name>
      <address>
        <city>Bernau</city>
        <zip>13321</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana-Herzzentrum Cottbus GmbH</name>
      <address>
        <city>Cottbus</city>
        <zip>03048</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>Goethe Universität</name>
      <address>
        <city>Frankfurt</city>
        <zip>60323</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätklinikum Giessen</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Halle</name>
      <address>
        <city>Halle</city>
        <zip>06097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Jena</name>
      <address>
        <city>Jena</city>
        <zip>07743</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städisches Klinikum Karlsruhe GmbH</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Klinik Fur Herzzchirurgie Karlsruhe</name>
      <address>
        <city>Karlsruhe</city>
        <zip>76185</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum</name>
      <address>
        <city>Köln</city>
        <zip>50924</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sana Herzzentrum Leipzig</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Städische Kliniken</name>
      <address>
        <city>Neuss</city>
        <zip>41464</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72016</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile di Legnano</name>
      <address>
        <city>Legnano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci</name>
      <address>
        <city>Massa</city>
        <zip>54100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital NHS</name>
      <address>
        <city>Leicester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oford University Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Poland</country>
    <country>Switzerland</country>
  </removed_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>October 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAVI</keyword>
  <keyword>Transcatheter Aortic Valve Replacement</keyword>
  <keyword>Transcatheter Aortic Valve Implant</keyword>
  <keyword>Transfemoral access</keyword>
  <keyword>Aortic valve regurgitation</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).</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/NCT02987894
org study id: 2016-02
nct id: NCT02987894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this post-market registry is to collect and monitor ongoing safety and
      performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™
      Transferral Delivery System, when used as per IFU.
The primary objective of this post-market registry is to further evaluate the safety and
      performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery
      System in 500 consented patients with severe aortic stenosis and treated according to the
      instructions for use (IFU).

      Examinations to evaluate the aortic valve regurgitation performed as standard of care in
      patients undergoing transcatheter aortic valve replacement will be analyzed by an external
      Core Laboratory. These examinations are limited to echocardiography and/or contrast
      aortography assessments.

      The secondary objective is to collect adverse events and evaluate them according to the
      VARC-2 consensus document.
observational model: Cohort
time perspective: Prospective
measure: Change in total aortic regurgitation over time.
time frame: post-implantation on index procedure date, 7- days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
description: total aortic regurgitation post procedure, at 7 days or discharge, 30 days and 12 months follow-up
measure: Incidence of all-cause mortality
time frame: 30 days post-index procedure
description: Incidence of all-cause mortality at 30 days post index procedure
measure: Clinical events as defined per VARC-2 consensus document (VARC-2)
time frame: Procedure, 7 days post-index procedure / discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
description: Clinical events as defined per VARC-2 consensus document
measure: Number of patients with procedural success according to VARC II criteria
time frame: at index- Procedure
description: Procedural success is defined as
Absence of intra-procedure mortality and complications arising during implantation of the prosthetic valve such as:
inability to properly seat the valve in the annulus
need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment)
surgical aortic valve replacement required to correct a severe aortic regurgitation or procedure complication The procedure can be considered as success despite the presence of residual aortic regurgitation which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.
measure: Number of patients with device success
time frame: 7-days post-index procedure or discharge (whichever occurs first)
description: Device success is defined as:
Absence of intra-procedure mortality (procedure to 24H) AND,
Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,
Intended performance of the prosthetic heart valve:
No prosthesis-patient mismatch (EAOi >0.85 cm2/m2) AND,
Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND,
No moderate or severe prosthetic valve regurgitation.
In evaluating echo parameters, values at 7D/Discharge (whichever occurs first) will be used for each of the echo parameters above. If any of echo parameters is missing at 7-days or discharge, post-procedure data may be used for the missing values. If device success or failure cannot be determined due to missing of parameters listed above or un-evaluable echocardiography assessment, device success will be considered not obtainable.
measure: Number of patients with adverse events assessed by VARC-2 Composite Safety
time frame: 30 days post-index procedure
description: VARC-2 Composite Safety at 30 days defined as:
All-cause mortality
All stroke (disabling and non-disabling)
Life-threatening bleeding
Acute kidney injury - Stage 2 or 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complication
Valve-related dysfunction requiring repeat procedure (BAV, TAVI or SAVI)
measure: Functional improvement
time frame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
description: Functional improvement from baseline as per NYHA Functional Classification
measure: Hemodynamic function improvement from baseline
time frame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
description: Improvement from baseline of the hemodynamic function: effective orifice area and mean transprosthetic gradient
measure: Valve related dysfunction
time frame: 7 days post-index procedure or discharge (whichever occurs first), 30 days post-index procedure and 12 months post-index procedure
description: Valve related dysfunction defined as: mean aortic valve gradient ≥ 20mmHg, EOA ≤0.9-1.1 cm2, and/or DVI< 0.35, and/or moderate or severe prosthetic valve regurgitation (See VARC-2 and Figure 4 from VARC manuscript)
intervention type: Device
intervention name: ACURATE neo™ Aortic Bioprosthesis
description: TAVI, transcatheter aortic valve replacement. Transfemoral access.
other name: ACURATE TF™ Transfemoral Delivery System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Won-Keun Kim, Dr
role: Principal Investigator
affiliation: Kerckhoff-Klinik Forschungsgesellschaft mbH
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Canada
country: Germany
country: Italy
country: United Kingdom
country: Argentina
country: Poland
country: Switzerland
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Valve Insufficiency
sharing ipd: Undecided
ipd description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).