<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/NCT02981004</url>
  </required_header>
  <id_info>
    <org_study_id>CS-09-015-GE-TV</org_study_id>
    <nct_id>NCT02981004</nct_id>
  </id_info>
  <brief_title>PAR I - Patient-to-Annulus Relation I</brief_title>
  <acronym>PARI</acronym>
  <official_title>PAR I - Prothesis-to-Annulus Relation (PAR) as Predictor of Hemodynamic Outcome in Aortic Valve Replacement</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing&#xD;
      the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for&#xD;
      the prediction of hemodynamic outcome. The results may possibly guide future valve size&#xD;
      selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Great debates revolve around the hemodynamic performance of prosthetic tissue valves. It is&#xD;
      influenced by the design and the specific sizing strategy. Design determines the actual&#xD;
      geometric orifice area (GOA), sizing strategy the actual size of the selected valve.&#xD;
      Currently, hemodynamic performance is generally assessed by determining the effective orifice&#xD;
      area (EOA, derived from the continuity equation by relating flow velocities and LVOT area).&#xD;
      The question whether a prosthesis patient mismatch (PPM) is present is then addressed by&#xD;
      relating EOA to body surface area (EOAi). However, this relation may not be reasonable&#xD;
      because EOAi relates flow velocity twice to patient-specific anatomic parameters (LVOT area&#xD;
      and body surface area) . Considering this potential methodological flaw, debate and confusion&#xD;
      regarding PPM is easily understood, despite the fact that, intuitively leaving a gradient&#xD;
      behind after aortic valve replacement cannot be irrelevant. Thus a reliable and comparable&#xD;
      method to determine the presence of PPM is needed. In PAR I Trial the relation between true&#xD;
      prothetic GOA and LVOT area will be assesses as a potentially new parameter for prediction of&#xD;
      hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve)&#xD;
      and to allow the detection of functionally relevant PPM. In the trial it will be assessed how&#xD;
      anatomic dimensions of patients and implanted valves relate to each other and whether they&#xD;
      allow the prediction of hemodynamic outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2012</start_date>
  <completion_date type="Actual">December 18, 2017</completion_date>
  <primary_completion_date type="Actual">December 18, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>recording of hemodynamic outcome of a aortic valve in mutual dependence of anatomical facts on the basis of echocardiographic parameter</measure>
    <time_frame>postprocedure before discharge (less than 30 days after implant)</time_frame>
    <description>Echocardiographic evaluation of the anatomical facts e.g. Left ventricular outflow area</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality 30 days after implant</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morbidity 30 days after implant</measure>
    <time_frame>30 days</time_frame>
    <description>Morbidity</description>
  </secondary_outcome>
  <enrollment type="Actual">304</enrollment>
  <condition>Aortic Valve Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with aortic valve disease selected for tissue valve implantation (routine care)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:1.Patient has an indication for primary, isolated aortic valve&#xD;
        implantation 2. Patient is above 18 Years old 3. Patient has signed patient informed&#xD;
        consent 4. foreseen implantation of an Epic, Epic supra or Trifecta valve 5. Patient has&#xD;
        sinus rhythm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient is younger than 18 years&#xD;
&#xD;
          2. Patient has active endocarditis&#xD;
&#xD;
          3. Patient is not able or does not want to participate on follow-up&#xD;
&#xD;
          4. Patient is pregnant or nursing&#xD;
&#xD;
          5. Surgical widening of outflow tract is planned&#xD;
&#xD;
          6. Left ventricular ejection fraction is smaller than 50%&#xD;
&#xD;
          7. Patient has a mitral valve or tricuspid valve insufficiency or stenosis bigger or&#xD;
             equal Grade II&#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>Torsten Doenst, M.D.Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Head of Cardiac surgery department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herzzentrum Dresden</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios St. Georg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiothoracic Surgery</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Bogenhausen</name>
      <address>
        <city>Munich</city>
        <zip>81925</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herz- und Kreislaufzentrum Rotenburg / Fulda</name>
      <address>
        <city>Rotenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Brüder</name>
      <address>
        <city>Trier</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Ulm</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>October 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic valve disease, patient prosthesis mismatch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Disease</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/NCT02981004
org study id: CS-09-015-GE-TV
nct id: NCT02981004
lead sponsor: 
has dmc: No
The Prosthesis-to-Annulus Relation I (PAR I) trial is a German multicenter study assessing
      the relation between the prosthetic GOA and the area of LVOT as potentially new parameter for
      the prediction of hemodynamic outcome. The results may possibly guide future valve size
      selection an may allow prediction of functionally relevant PPM (Patient-Prosthesis-Mismatch)
Great debates revolve around the hemodynamic performance of prosthetic tissue valves. It is
      influenced by the design and the specific sizing strategy. Design determines the actual
      geometric orifice area (GOA), sizing strategy the actual size of the selected valve.
      Currently, hemodynamic performance is generally assessed by determining the effective orifice
      area (EOA, derived from the continuity equation by relating flow velocities and LVOT area).
      The question whether a prosthesis patient mismatch (PPM) is present is then addressed by
      relating EOA to body surface area (EOAi). However, this relation may not be reasonable
      because EOAi relates flow velocity twice to patient-specific anatomic parameters (LVOT area
      and body surface area) . Considering this potential methodological flaw, debate and confusion
      regarding PPM is easily understood, despite the fact that, intuitively leaving a gradient
      behind after aortic valve replacement cannot be irrelevant. Thus a reliable and comparable
      method to determine the presence of PPM is needed. In PAR I Trial the relation between true
      prothetic GOA and LVOT area will be assesses as a potentially new parameter for prediction of
      hemodynamic outcome, to possibly guide future valve size selection (inclusive valve-in-valve)
      and to allow the detection of functionally relevant PPM. In the trial it will be assessed how
      anatomic dimensions of patients and implanted valves relate to each other and whether they
      allow the prediction of hemodynamic outcome.
observational model: Case-Only
time perspective: Prospective
measure: recording of hemodynamic outcome of a aortic valve in mutual dependence of anatomical facts on the basis of echocardiographic parameter
time frame: postprocedure before discharge (less than 30 days after implant)
description: Echocardiographic evaluation of the anatomical facts e.g. Left ventricular outflow area
measure: Mortality 30 days after implant
time frame: 30 days
description: Mortality
measure: Morbidity 30 days after implant
time frame: 30 days
description: Morbidity
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Torsten Doenst, M.D.Ph.D.
role: Principal Investigator
affiliation: Head of Cardiac surgery department
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Aortic Valve Disease