<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/NCT03258333</url>
  </required_header>
  <id_info>
    <org_study_id>FederalCCS002</org_study_id>
    <nct_id>NCT03258333</nct_id>
  </id_info>
  <brief_title>Small Aortic Annulus - a New Solution to the Old Problem</brief_title>
  <official_title>Small Aortic Annulus - a New Solution to the Old Problem</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Federal Centre of Cardiovascular Surgery, Russia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Federal Centre of Cardiovascular Surgery, Russia</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this prospective single-center study included 60 patients with a severe degenerative&#xD;
      aortic stenosis and small aortic annulus (&lt;21 mm) who underwent standard AVR with stented&#xD;
      bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium&#xD;
      (Ozaki procedure) (group 2, n=30)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging&#xD;
      problem. Implantation of a small aortic valve sometimes leads to high residual gradients,&#xD;
      despite a normally functioning prosthesis. Patients with a small aortic annulus, especially&#xD;
      those with a large body surface area, are at higher risk of prosthesis-patient mismatch,&#xD;
      which is associated with worse clinical outcomes and decreased survival. The purpose of this&#xD;
      study was to compare the hemodynamic performance among the 2 management strategies (standard&#xD;
      AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus&#xD;
      (&lt;21 mm)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 18, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>Indexed effective orifice area, cm²/m²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Assessment of aortic valve dimension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prosthesis-patient mismatch (PPM)</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Indicator of the effectiveness of aortic valve replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak pressure gradient, mm.Hg</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Indicator of the effectiveness of aortic valve replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean pressure gradient, mm.Hg</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Indicator of the effectiveness of aortic valve replacement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective orifice area, EOA, cm²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Assessment of aortic valve dimension</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age (years)</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Description and comparison of groups patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index, kg/m²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Description and comparison of groups patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Body surface area, m²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Description and comparison of groups patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Aortic annulus diameter, mm</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Description and comparison of groups patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Indexed aortic annulus diameter, mm/m²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Description and comparison of groups patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial mass index, g/m²</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Assessment of reverse remodeling of the left ventricle</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Aortic Valve Replacement</condition>
  <arm_group>
    <arm_group_label>Stented bioprosthesis</arm_group_label>
    <description>Standard aortic valve replacement with stented bioprosthesis. Surgery is performed through median sternotomy, aortic and right or bicaval venous cannulation, normothermic perfusion, antegrade cardioplegia with use cardioplegic solution Custodiol. A transverse aortotomy was performed 1 to 2 cm above the right coronary artery. The aortic annulus was thoroughly débrided of calcium. Valve sizing was performed with standard manufacturers' sizers, with selection of the size that would comfortably fit within the aortic annulus. A noneverting suture technique was used in all patients with interrupted horizontal mattress 2-0 braided sutures placed around the aortic annulus, with the pledgets on the ventricular aspect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ozaki procedure</arm_group_label>
    <description>Aortic valve reconstruction using autologus pericardium (Ozaki procedure). The autologous pericardium is harvested after routine median sternotomy. Harvested pericardium is then treated with a 0.6% glutaraldehyde solution for 10 min and then rinsed 3 times with sterilized saline each time for 6 min. After resection of the diseased aortic valve cusps, the distance between each commissure is measured using a self-developed sizing instrument. Glutaraldehyde-treated autologous pericardium is trimmed with a self-developed template corresponding to the measured value. The annular margin of the pericardial leaflet is then running-sutured to each annulus with 3-0 monofilament sutures. Commissural coaptation is secured with additional 4-0 monofilament sutures. The coaptation of the 3 cusps is then checked with negative pressure on the left ventricular vent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>aortic valve replacement</intervention_name>
    <description>Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium</description>
    <arm_group_label>Ozaki procedure</arm_group_label>
    <arm_group_label>Stented bioprosthesis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with severe degenerative aortic stenosis and small aortic annulus (&lt;21 mm) were&#xD;
        enrolled in this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  severe degenerative aortic valve stenosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  redo operation, infective endocarditis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>FederalCCS</name>
      <address>
        <city>Penza</city>
        <zip>440071</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <reference>
    <citation>Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves. J Thorac Cardiovasc Surg. 2006 May;131(5):1058-64. doi: 10.1016/j.jtcvs.2005.12.034.</citation>
    <PMID>16678590</PMID>
  </reference>
  <results_reference>
    <citation>Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Hagiwara S, Kiyohara N. Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis. Circ J. 2015;79(7):1504-10. doi: 10.1253/circj.CJ-14-1092. Epub 2015 Mar 30.</citation>
    <PMID>25818901</PMID>
  </results_reference>
  <results_reference>
    <citation>Ozaki S, Kawase I, Yamashita H, Uchida S, Nozawa Y, Matsuyama T, Takatoh M, Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):550-3. doi: 10.1510/icvts.2010.253682. Epub 2011 Jan 27.</citation>
    <PMID>21273254</PMID>
  </results_reference>
  <results_reference>
    <citation>Borger MA, Nette AF, Maganti M, Feindel CM. Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. Ann Thorac Surg. 2007 Jun;83(6):2054-8. doi: 10.1016/j.athoracsur.2007.02.062.</citation>
    <PMID>17532395</PMID>
  </results_reference>
  <results_reference>
    <citation>Ghoneim A, Bouhout I, Demers P, Mazine A, Francispillai M, El-Hamamsy I, Carrier M, Lamarche Y, Bouchard D. Management of small aortic annulus in the era of sutureless valves: A comparative study among different biological options. J Thorac Cardiovasc Surg. 2016 Oct;152(4):1019-28. doi: 10.1016/j.jtcvs.2016.06.058. Epub 2016 Jul 28.</citation>
    <PMID>27641297</PMID>
  </results_reference>
  <results_reference>
    <citation>Morita S. Aortic valve replacement and prosthesis-patient mismatch in the era of trans-catheter aortic valve implantation. Gen Thorac Cardiovasc Surg. 2016 Aug;64(8):435-40. doi: 10.1007/s11748-016-0657-9. Epub 2016 May 27.</citation>
    <PMID>27234223</PMID>
  </results_reference>
  <results_reference>
    <citation>Minardi G, Pergolini A, Zampi G, Pulignano G, Pero G, Sbaraglia F, Pino PG, Cioffi G, Musumeci F. St. Jude Trifecta versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-echocardiography and hemodynamic performance. Monaldi Arch Chest Dis. 2013 Sep;80(3):126-32. doi: 10.4081/monaldi.2013.74.</citation>
    <PMID>24818319</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 20, 2017</last_update_submitted>
  <last_update_submitted_qc>August 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Federal Centre of Cardiovascular Surgery, Russia</investigator_affiliation>
    <investigator_full_name>Mikulyak Artur</investigator_full_name>
    <investigator_title>Principal Investigator, Cardiovascular surgeon</investigator_title>
  </responsible_party>
  <keyword>aortic stenosis, aortic valve replacement, pericardium</keyword>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03258333
org study id: FederalCCS002
nct id: NCT03258333
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this prospective single-center study included 60 patients with a severe degenerative
      aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented
      bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium
      (Ozaki procedure) (group 2, n=30)
Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging
      problem. Implantation of a small aortic valve sometimes leads to high residual gradients,
      despite a normally functioning prosthesis. Patients with a small aortic annulus, especially
      those with a large body surface area, are at higher risk of prosthesis-patient mismatch,
      which is associated with worse clinical outcomes and decreased survival. The purpose of this
      study was to compare the hemodynamic performance among the 2 management strategies (standard
      AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus
      (<21 mm)
observational model: Cohort
time perspective: Prospective
measure: Indexed effective orifice area, cm²/m²
time frame: 12 months after surgery
description: Assessment of aortic valve dimension
measure: prosthesis-patient mismatch (PPM)
time frame: 12 months after surgery
description: Indicator of the effectiveness of aortic valve replacement
measure: Peak pressure gradient, mm.Hg
time frame: 12 months after surgery
description: Indicator of the effectiveness of aortic valve replacement
measure: Mean pressure gradient, mm.Hg
time frame: 12 months after surgery
description: Indicator of the effectiveness of aortic valve replacement
measure: Effective orifice area, EOA, cm²
time frame: 12 months after surgery
description: Assessment of aortic valve dimension
measure: Age (years)
time frame: 12 months after surgery
description: Description and comparison of groups patients
measure: Body mass index, kg/m²
time frame: 12 months after surgery
description: Description and comparison of groups patients
measure: Body surface area, m²
time frame: 12 months after surgery
description: Description and comparison of groups patients
measure: Aortic annulus diameter, mm
time frame: 12 months after surgery
description: Description and comparison of groups patients
measure: Indexed aortic annulus diameter, mm/m²
time frame: 12 months after surgery
description: Description and comparison of groups patients
measure: Myocardial mass index, g/m²
time frame: 12 months after surgery
description: Assessment of reverse remodeling of the left ventricle
arm group label: Stented bioprosthesis
description: Standard aortic valve replacement with stented bioprosthesis. Surgery is performed through median sternotomy, aortic and right or bicaval venous cannulation, normothermic perfusion, antegrade cardioplegia with use cardioplegic solution Custodiol. A transverse aortotomy was performed 1 to 2 cm above the right coronary artery. The aortic annulus was thoroughly débrided of calcium. Valve sizing was performed with standard manufacturers' sizers, with selection of the size that would comfortably fit within the aortic annulus. A noneverting suture technique was used in all patients with interrupted horizontal mattress 2-0 braided sutures placed around the aortic annulus, with the pledgets on the ventricular aspect.
arm group label: Ozaki procedure
description: Aortic valve reconstruction using autologus pericardium (Ozaki procedure). The autologous pericardium is harvested after routine median sternotomy. Harvested pericardium is then treated with a 0.6% glutaraldehyde solution for 10 min and then rinsed 3 times with sterilized saline each time for 6 min. After resection of the diseased aortic valve cusps, the distance between each commissure is measured using a self-developed sizing instrument. Glutaraldehyde-treated autologous pericardium is trimmed with a self-developed template corresponding to the measured value. The annular margin of the pericardial leaflet is then running-sutured to each annulus with 3-0 monofilament sutures. Commissural coaptation is secured with additional 4-0 monofilament sutures. The coaptation of the 3 cusps is then checked with negative pressure on the left ventricular vent.
intervention type: Procedure
intervention name: aortic valve replacement
description: Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium
arm group label: Ozaki procedure
arm group label: Stented bioprosthesis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Russian Federation
citation: Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves. J Thorac Cardiovasc Surg. 2006 May;131(5):1058-64. doi: 10.1016/j.jtcvs.2005.12.034.
PMID: 16678590
citation: Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Hagiwara S, Kiyohara N. Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis. Circ J. 2015;79(7):1504-10. doi: 10.1253/circj.CJ-14-1092. Epub 2015 Mar 30.
PMID: 25818901
citation: Ozaki S, Kawase I, Yamashita H, Uchida S, Nozawa Y, Matsuyama T, Takatoh M, Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):550-3. doi: 10.1510/icvts.2010.253682. Epub 2011 Jan 27.
PMID: 21273254
citation: Borger MA, Nette AF, Maganti M, Feindel CM. Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. Ann Thorac Surg. 2007 Jun;83(6):2054-8. doi: 10.1016/j.athoracsur.2007.02.062.
PMID: 17532395
citation: Ghoneim A, Bouhout I, Demers P, Mazine A, Francispillai M, El-Hamamsy I, Carrier M, Lamarche Y, Bouchard D. Management of small aortic annulus in the era of sutureless valves: A comparative study among different biological options. J Thorac Cardiovasc Surg. 2016 Oct;152(4):1019-28. doi: 10.1016/j.jtcvs.2016.06.058. Epub 2016 Jul 28.
PMID: 27641297
citation: Morita S. Aortic valve replacement and prosthesis-patient mismatch in the era of trans-catheter aortic valve implantation. Gen Thorac Cardiovasc Surg. 2016 Aug;64(8):435-40. doi: 10.1007/s11748-016-0657-9. Epub 2016 May 27.
PMID: 27234223
citation: Minardi G, Pergolini A, Zampi G, Pulignano G, Pero G, Sbaraglia F, Pino PG, Cioffi G, Musumeci F. St. Jude Trifecta versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-echocardiography and hemodynamic performance. Monaldi Arch Chest Dis. 2013 Sep;80(3):126-32. doi: 10.4081/monaldi.2013.74.
PMID: 24818319
responsible party type: Principal Investigator
investigator affiliation: The Federal Centre of Cardiovascular Surgery, Russia
investigator full name: Mikulyak Artur
investigator title: Principal Investigator, Cardiovascular surgeon
sharing ipd: Yes