<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/NCT04473443</url>
  </required_header>
  <id_info>
    <org_study_id>PRECISE TAVI</org_study_id>
    <nct_id>NCT04473443</nct_id>
  </id_info>
  <brief_title>Addition of Computer Simulations to Minimize Adverse Events After Transcatheter Aortic Valve Implantation</brief_title>
  <acronym>PRECISE_TAVI</acronym>
  <official_title>Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Feops</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</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 objective is to assess the influence of FEops HEARTguide on overall device success in&#xD;
      TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV)&#xD;
      platform selection (Cohort B).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat&#xD;
      patients with severe aortic stenosis. However, by extending the indication for TAVI,&#xD;
      simulation may become increasingly important to improve procedure execution, safety and&#xD;
      efficacy.&#xD;
&#xD;
      Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging&#xD;
      anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).&#xD;
&#xD;
      Study design Prospective, observational multi-center trial with 2 cohorts.&#xD;
&#xD;
      Study population&#xD;
&#xD;
        1. Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic,&#xD;
           Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall&#xD;
           device success through valve size and implantation depth.&#xD;
&#xD;
        2. Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston&#xD;
           Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM&#xD;
           on overall device success and PVL prediction.&#xD;
&#xD;
      Main Endpoints&#xD;
&#xD;
      1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2.&#xD;
      Incidence of &gt; trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</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>overall device success conform the VARC-2 document</measure>
    <time_frame>30 days after TAVI</time_frame>
    <description>Incidence of mortality&#xD;
incidence of stroke&#xD;
incidence of major vascular complication&#xD;
incidence of life-threatening bleeding</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of more than trivial PVL</measure>
    <time_frame>30 days after TAVI</time_frame>
    <description>total incidence of trivial PVL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>conduction abnormalities and need for new permanent pacemaker implantation</measure>
    <time_frame>30 days after TAVI</time_frame>
    <description>incidence of new permanent pacemaker implantations&#xD;
incidence of left bundle branch block&#xD;
incidence of total AV block</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Bicuspid Cardiac Valve</condition>
  <arm_group>
    <arm_group_label>Cohort A</arm_group_label>
    <description>Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort B</arm_group_label>
    <description>Consecutive patients eligible for TAVI with ACURATE-NEO2 valve</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FEops HEARTguideTM</intervention_name>
    <description>A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.</description>
    <arm_group_label>Cohort A</arm_group_label>
    <arm_group_label>Cohort B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This prospective multi-center international Registry of TAVI patients include for Cohort A&#xD;
        patients with the following complex anatomy: BAV (Sievers 0 or 1) or functional bicuspid&#xD;
        aortic valves, severely calcified aortic valve and small aortic roots.&#xD;
&#xD;
        And for Cohort B consecutive patients eligible for TAVI with ACURATE-NEO2-valve&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cohort A:&#xD;
&#xD;
               1. Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid&#xD;
                  Aortic Valve&#xD;
&#xD;
               2. Patients with a severely calcified aortic valve (Agatston score &gt; 3000 for men,&#xD;
                  and &gt; 1600 for women)&#xD;
&#xD;
               3. Patients with small anatomy defined by mean aortic annulus diameter &lt; 20mm&#xD;
&#xD;
          -  Cohort B:&#xD;
&#xD;
               1. every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  poor CT quality&#xD;
&#xD;
          -  previous aortic valve replacement&#xD;
&#xD;
          -  Permanent pacemaker at baseline&#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>Nicolas van Mieghem, Md,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas van Mieghem, MD, PhD</last_name>
    <phone>+31107035260</phone>
    <email>n.vanmieghem@erasmusmc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Thijmen Hokken, MD</last_name>
    <phone>+31107038896</phone>
    <email>t.hokken@erasmusmc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015GD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas van Mieghem, MD, PhD</last_name>
      <phone>+31(0)107035260</phone>
      <email>n.vanmieghem@erasmusmc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.</citation>
    <PMID>23084102</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 25, 2022</last_update_submitted>
  <last_update_submitted_qc>July 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Nicolas van Mieghem</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04473443
org study id: PRECISE TAVI
nct id: NCT04473443
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective is to assess the influence of FEops HEARTguide on overall device success in
      TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV)
      platform selection (Cohort B).
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat
      patients with severe aortic stenosis. However, by extending the indication for TAVI,
      simulation may become increasingly important to improve procedure execution, safety and
      efficacy.

      Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging
      anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).

      Study design Prospective, observational multi-center trial with 2 cohorts.

      Study population

        1. Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic,
           Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall
           device success through valve size and implantation depth.

        2. Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston
           Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM
           on overall device success and PVL prediction.

      Main Endpoints

      1. Overall device success conform VARC-2 including need for new permanent pacemaker. 2.
      Incidence of > trivial Paravalvular leakage (PVL) 3. Need for new permanent pacemaker
observational model: Cohort
time perspective: Prospective
measure: overall device success conform the VARC-2 document
time frame: 30 days after TAVI
description: Incidence of mortality
incidence of stroke
incidence of major vascular complication
incidence of life-threatening bleeding
measure: incidence of more than trivial PVL
time frame: 30 days after TAVI
description: total incidence of trivial PVL
measure: conduction abnormalities and need for new permanent pacemaker implantation
time frame: 30 days after TAVI
description: incidence of new permanent pacemaker implantations
incidence of left bundle branch block
incidence of total AV block
arm group label: Cohort A
description: Patients with a challenging anatomy, including bicuspid aortic valve, severely calcified aortic valves or small aortic roots
arm group label: Cohort B
description: Consecutive patients eligible for TAVI with ACURATE-NEO2 valve
intervention type: Other
intervention name: FEops HEARTguideTM
description: A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.
arm group label: Cohort A
arm group label: Cohort B
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas van Mieghem, Md,PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
last name: Nicolas van Mieghem, MD, PhD
phone: +31107035260
email: n.vanmieghem@erasmusmc.nl
last name: Thijmen Hokken, MD
phone: +31107038896
email: t.hokken@erasmusmc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
citation: Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
PMID: 23084102
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Nicolas van Mieghem
investigator title: principal investigator
mesh term: Aortic Valve Stenosis
sharing ipd: Undecided