<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/NCT02241447</url>
  </required_header>
  <id_info>
    <org_study_id>IMPULSE</org_study_id>
    <nct_id>NCT02241447</nct_id>
  </id_info>
  <brief_title>Quality of Care in AS IMPULSE Study</brief_title>
  <acronym>IMPULSE</acronym>
  <official_title>Study to Improve Outcomes in Aortic Stenosis. International, Multi-center, Prospective, Observation and Interventional Cohort Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut für Pharmakologie und Präventive Medizin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut für Pharmakologie und Präventive Medizin</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 study is to narrow the gap between patients being diagnosed with severe&#xD;
      aortic stenosis and those being appropriately monitored and treated. For this purpose a&#xD;
      prospective survey of current practice (3 months) will be conducted followed by a six month&#xD;
      period of intervention during which a variety of quality improvements measures will be&#xD;
      implemented. There will then be a 3 month follow-up period during which the legacy of this&#xD;
      initiative will be monitored during which no intervention will be carried out.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients meeting pre-specified criteria (severe aortic stenosis whether with or without&#xD;
      symptoms) will be collected. There will be three phases at each site observation A,&#xD;
      intervention, observation B. Observation A: In this phase, the nurse identifies cases with&#xD;
      severe AS and collects their data. Baseline data for each patient will be collected and a&#xD;
      follow-up will be done after three months for each patient to determine his/her outcome and&#xD;
      the treatment that was decided on. There will also be an optional telephone follow-up to find&#xD;
      out the patient's outcome.&#xD;
&#xD;
      Intervention: In this phase, the physician referring a patient for echocardiography will be&#xD;
      notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the&#xD;
      attention of the referring physician within a week (via phone, e-mail or letter) to make them&#xD;
      aware of the diagnosis.&#xD;
&#xD;
      Baseline and follow-up data will be collected for each patient as before. Moreover, more&#xD;
      detailed data with regard to the patient's health status will be documented.&#xD;
&#xD;
      Observation B: Same as Observation Phase A&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 8, 2014</start_date>
  <completion_date type="Actual">May 31, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</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>3 Months</target_duration>
  <primary_outcome>
    <measure>Referral rates at 3 months for Intervention (SAVR or TAVI)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Referral rates at 3 months for exercise testing or stress echocardiography</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next out-patient appointment or clinical review</measure>
    <time_frame>15 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriateness of treatment decisions made in collaboration with the valve specialist</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2173</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <description>the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early information</arm_group_label>
    <description>in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults aged over 18years identified on echocardiography with severe AS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aortic valve area &lt; 1cm2&#xD;
&#xD;
          -  Indexed aortic valve area &lt;0.6 cm/m2&#xD;
&#xD;
          -  Maximum Jet velocity &gt; 4.0 m/sec&#xD;
&#xD;
          -  Mean transvalvular gradient &gt; 40 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-severe aortic Stenosis (AS)&#xD;
&#xD;
          -  Previous aortic valve replacement (AVR)&#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>Richard Steeds, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Elizabeth Hospital, Birmingham, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norbert Frey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology and Angiology, University of Kiel, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Davia Messika-Zeitoun, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Bichat, Paris FR</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Krankenhaus Hietzing</name>
      <address>
        <city>Wien</city>
        <zip>1130</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IKEM - Institute for Clinical and Experimental Medicine</name>
      <address>
        <city>Prag</city>
        <zip>140 21</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Annecy</name>
      <address>
        <city>Annecy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bichat Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité - Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>10233</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westpfalz Klinikum</name>
      <address>
        <city>Kaiserslautern</city>
        <zip>67655</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKSK Campus Kiel, Klinik für Kardiologie und Angiologie</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Universitätsklinikum Köln</name>
      <address>
        <city>Köln</city>
        <zip>50924</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>Städtisches Klinikum München</name>
      <address>
        <city>München</city>
        <zip>80337</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Brüder</name>
      <address>
        <city>Trier</city>
        <zip>54292</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Università degli Studi di Bari Aldo Moro</name>
      <address>
        <city>Bari</city>
        <zip>70121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University &quot;Magna Græcia&quot; of Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS San Matteo Hospital</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I Rom</name>
      <address>
        <city>Rom</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Torino</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMC Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Creu Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08025</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitätsSpital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bart Heart Center</name>
      <address>
        <city>London</city>
        <zip>E1 1BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>James Cook University Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://europepmc.org/article/PMC/6806053</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/31302639</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aortic valve Stenosis</keyword>
  <keyword>Echo</keyword>
  <keyword>TAVI</keyword>
  <keyword>SAVR</keyword>
  <keyword>referral</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>
  <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/NCT02241447
org study id: IMPULSE
nct id: NCT02241447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to narrow the gap between patients being diagnosed with severe
      aortic stenosis and those being appropriately monitored and treated. For this purpose a
      prospective survey of current practice (3 months) will be conducted followed by a six month
      period of intervention during which a variety of quality improvements measures will be
      implemented. There will then be a 3 month follow-up period during which the legacy of this
      initiative will be monitored during which no intervention will be carried out.
All patients meeting pre-specified criteria (severe aortic stenosis whether with or without
      symptoms) will be collected. There will be three phases at each site observation A,
      intervention, observation B. Observation A: In this phase, the nurse identifies cases with
      severe AS and collects their data. Baseline data for each patient will be collected and a
      follow-up will be done after three months for each patient to determine his/her outcome and
      the treatment that was decided on. There will also be an optional telephone follow-up to find
      out the patient's outcome.

      Intervention: In this phase, the physician referring a patient for echocardiography will be
      notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the
      attention of the referring physician within a week (via phone, e-mail or letter) to make them
      aware of the diagnosis.

      Baseline and follow-up data will be collected for each patient as before. Moreover, more
      detailed data with regard to the patient's health status will be documented.

      Observation B: Same as Observation Phase A
observational model: Cohort
time perspective: Prospective
measure: Referral rates at 3 months for Intervention (SAVR or TAVI)
time frame: 3 months
measure: Referral rates at 3 months for exercise testing or stress echocardiography
time frame: 3 months
measure: Time to next out-patient appointment or clinical review
time frame: 15 months
measure: Type of intervention selected (SAVR, TAVI, watchful waiting or no treatment)
time frame: 3 months
measure: Appropriateness of treatment decisions made in collaboration with the valve specialist
time frame: 3 months
measure: Outcomes (survival) at 1 year (telephone FU) including the time between diagnosis and treatment
time frame: 3 months
arm group label: Observation
description: the nurse identifies cases with severe AS and collects their data. Baseline data for each patient will be collected and a follow-up will be done after three months for each patient to determine his/her outcome and the treatment that was decided on
arm group label: Early information
description: in this arm, the physician referring a patient for echocardiography will be notified of a finding of severe aortic stenosis: the nurse brings cases with severe AS to the attention of the referring physician within a week (via phone, e-mail or letter) to make them aware of the diagnosis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Steeds, MD
role: Principal Investigator
affiliation: Queen Elizabeth Hospital, Birmingham, UK
last name: Norbert Frey, MD
role: Principal Investigator
affiliation: Department of Cardiology and Angiology, University of Kiel, Germany
last name: Davia Messika-Zeitoun, MD
role: Principal Investigator
affiliation: Hôpital Bichat, Paris FR
facility: 
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country: Austria
country: Czechia
country: France
country: Germany
country: Italy
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
country: Czech Republic
url: https://europepmc.org/article/PMC/6806053
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/31302639
description: Related Info
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic
sharing ipd: Undecided