<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/NCT04503655</url>
  </required_header>
  <id_info>
    <org_study_id>2020/0185/HP</org_study_id>
    <nct_id>NCT04503655</nct_id>
  </id_info>
  <brief_title>Multicenter Study Evaluating the Efficacy of an Intervention Aimed at Reducing the Length of Stay After Transfemoral Transcatheter Aortic Valve Implantation</brief_title>
  <acronym>FAST-TAVI II</acronym>
  <official_title>Etude Multicentrique évaluant l'efficacité d'Une Intervention Visant à réduire la durée de séjour après l'Implantation d'Une bioprothèse Aortique Par Voie transfémorale</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier&#xD;
      et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic&#xD;
      stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is&#xD;
      also recommended in patients at intermediate risk, especially when a femoral approach (TF) is&#xD;
      possible (Baumgartner et al. Eur Heart J. 2017).&#xD;
&#xD;
      Currently, there is no recommendation regarding length of stay after TAVI and practices are&#xD;
      extremely heterogeneous. Despite the growing experience of centers, better patient selection&#xD;
      and a reduction in complications, the length of stay after TAVI remains very high in France.&#xD;
&#xD;
      Faced with the great disparity observed between the centers, efforts are necessary to educate&#xD;
      the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study&#xD;
      is to evaluate the effectiveness of an intervention based on training teams to reduce the&#xD;
      length of stay after TF-TAVI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2020</start_date>
  <completion_date type="Actual">February 9, 2022</completion_date>
  <primary_completion_date type="Actual">February 9, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In this study, there is a randomization of the participating centres in two groups.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the effectiveness of a multi-component organizational intervention</measure>
    <time_frame>Year 1</time_frame>
    <description>Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety of the intervention</measure>
    <time_frame>Day 30</time_frame>
    <description>This outcome will be evaluated using :&#xD;
the average length of stay,&#xD;
the 30-day rehospitalization rate and&#xD;
the 30-day death rate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the budgetary impact of the intervention</measure>
    <time_frame>Year 1</time_frame>
    <description>This outcome will be assessed using:&#xD;
the hospital costs from the point of view of the hospital and&#xD;
the financial gains for health insurance that would be associated with the generalization of the intervention in France.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the implementation of the intervention</measure>
    <time_frame>Year 1</time_frame>
    <description>This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To identify the factors associated with the effectiveness and safety of the intervention</measure>
    <time_frame>Year 1</time_frame>
    <description>This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1842</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The randomized centres in this group will be follow a training dedicated on implementation of &quot;organizational&quot; and &quot;therapeutic&quot; measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The randomized centres in this group will not change their practices.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training</intervention_name>
    <description>Training dedicated on implementation of &quot;organizational&quot; and &quot;therapeutic&quot; measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient over 18 years of age;&#xD;
&#xD;
          2. Patient hospitalized for TF-TAVI&#xD;
&#xD;
          3. Patient affiliated or benefiting from a health insurance scheme&#xD;
&#xD;
          4. Patient having read and understood the information letter and having signed the&#xD;
             consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of&#xD;
             effective contraception (as defined by the WHO) or postmenopausal woman without&#xD;
             confirmation diagnosis obtained (amenorrhea not medically induced for at least 12&#xD;
             months before the initiation visit) ; 1&#xD;
&#xD;
          2. Person deprived of their liberty by an administrative or judicial decision or person&#xD;
             placed under the protection of justice / guardianship or curatorship&#xD;
&#xD;
          3. History of illness or psychological or sensory abnormality likely to prevent the&#xD;
             subject from fully understanding the conditions required for participating in the&#xD;
             protocol or preventing him from giving his informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU d'Amiens</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital privé Saint Martin</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor (AP-HP)</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital privé Jacques Cartier</name>
      <address>
        <city>Massy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique du Millénaire</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bichat, AP-HP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou (AP-HP)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de 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>Clinique Saint Gatien</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TAVI</keyword>
  <keyword>Aortic valve stenosis</keyword>
  <keyword>Lenght-of-stay</keyword>
  <keyword>Medico-economy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04503655
org study id: 2020/0185/HP
nct id: NCT04503655
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the first implantation of a percutaneous aortic bioprosthesis (TAVI) in 2002 (Cribier
      et al. Circulation 2002), TAVI occupies an increasing place in the management of aortic
      stenosis (AR) . Initially reserved for inoperable patients at high surgical risk, TAVI is
      also recommended in patients at intermediate risk, especially when a femoral approach (TF) is
      possible (Baumgartner et al. Eur Heart J. 2017).

      Currently, there is no recommendation regarding length of stay after TAVI and practices are
      extremely heterogeneous. Despite the growing experience of centers, better patient selection
      and a reduction in complications, the length of stay after TAVI remains very high in France.

      Faced with the great disparity observed between the centers, efforts are necessary to educate
      the centers in order to further reduce the length of stay after TF-TAVI. The aim of the study
      is to evaluate the effectiveness of an intervention based on training teams to reduce the
      length of stay after TF-TAVI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, there is a randomization of the participating centres in two groups.
primary purpose: Other
masking: None (Open Label)
measure: To evaluate the effectiveness of a multi-component organizational intervention
time frame: Year 1
description: Proportion of patients benefiting from TF-TAVI with a length of stay less than or equal to 3 days.
measure: To evaluate the safety of the intervention
time frame: Day 30
description: This outcome will be evaluated using :
the average length of stay,
the 30-day rehospitalization rate and
the 30-day death rate.
measure: To evaluate the budgetary impact of the intervention
time frame: Year 1
description: This outcome will be assessed using:
the hospital costs from the point of view of the hospital and
the financial gains for health insurance that would be associated with the generalization of the intervention in France.
measure: To evaluate the implementation of the intervention
time frame: Year 1
description: This outcome will be evaluated using the rate of adherence of the centers to the procedures aiming to reduce the length of stay (questionnaires)
measure: To identify the factors associated with the effectiveness and safety of the intervention
time frame: Year 1
description: This outcome will be assessed using factors associated with lengths of stay less than or equal to 3 days.
arm group label: Intervention group
arm group type: Experimental
description: The randomized centres in this group will be follow a training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.
arm group label: Control group
arm group type: No Intervention
description: The randomized centres in this group will not change their practices.
intervention type: Other
intervention name: Training
description: Training dedicated on implementation of "organizational" and "therapeutic" measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
responsible party type: Sponsor
mesh term: Cardiovascular Diseases
mesh term: Aortic Valve Stenosis
sharing ipd: No