<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/NCT04470102</url>
  </required_header>
  <id_info>
    <org_study_id>188</org_study_id>
    <nct_id>NCT04470102</nct_id>
  </id_info>
  <brief_title>Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy</brief_title>
  <acronym>PRIZMA-pilot</acronym>
  <official_title>A Randomised Controlled Pilot Trial: Edge-to-edge Mitral Valve Repair in the Surgical Treatment for Hypertrophic Cardiomyopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</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>
      Objective of the study: to evaluate whether edge-to-edge technique improves clinical and&#xD;
      hemodynamic results in patients scheduled to septal myectomy for severely symptomatic&#xD;
      hypertrophic obstructive cardiomyopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves&#xD;
      clinical and hemodynamic results in patients scheduled to septal myectomy for severely&#xD;
      symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic&#xD;
      cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal&#xD;
      myectomy. If patients were suitable for both surgical techniques, they were randomized to&#xD;
      septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons&#xD;
      were experienced at least 50 related procedures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 12, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</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>A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>no data</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Left Ventricular Outflow Tract (LVOT) gradient</measure>
    <time_frame>12 months in the medium-term follow-up</time_frame>
    <description>Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic anterior motion of the mitral valve</measure>
    <time_frame>12 months in the medium-term follow-up</time_frame>
    <description>Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Hypertrophic Obstructive Cardiomyopathy</condition>
  <arm_group>
    <arm_group_label>isolated septal myectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Isolated extended septal myectomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Septal myectomy+ &quot;edge-to-edge&quot;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mitral valve repair by edge-to-edge technique</intervention_name>
    <description>transaortic access for mitral valve repair edge-to-edge</description>
    <arm_group_label>Septal myectomy+ &quot;edge-to-edge&quot;</arm_group_label>
    <other_name>Alfieri stitch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Septal myectomy</intervention_name>
    <description>isolated extended septal myectomy</description>
    <arm_group_label>isolated septal myectomy</arm_group_label>
    <other_name>Septal myectomy (SM)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provide written informed consent (either from the patient or a substitute&#xD;
             decision-maker)&#xD;
&#xD;
          -  Indications for surgical treatment (septal myectomy) of hypertrophic cardiomyopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  indications for mitral valve replacement&#xD;
&#xD;
          -  Patient failure at any stage of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander V. Bogachev-Prokophiev, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>E.Meshalkin National medical research center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alexander V. Bogachev-Prokophiev, MD, PhD</last_name>
    <phone>+73833476029</phone>
    <email>bogachev.prokophiev@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sergei A. Budagaev</last_name>
    <phone>+73833476029</phone>
    <email>ser.bud.med@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>&quot;E.Meshalkin National medical research center&quot; of the Ministry of Health of the Russian Federation</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexander V. Bogachev-Prokophiev, MD, PhD</last_name>
      <phone>+73833476029</phone>
      <email>bogachev.prokophiev@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Sergei Budagaev</last_name>
      <phone>89021606921</phone>
      <email>ser.bud.med@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 19, 2020</last_update_submitted>
  <last_update_submitted_qc>July 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>edge-to-edge repair</keyword>
  <keyword>mitral valve plastic (MVP)</keyword>
  <keyword>Septal myectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Hypertrophic</mesh_term>
    <mesh_term>Hypertrophy</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/NCT04470102
org study id: 188
nct id: NCT04470102
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective of the study: to evaluate whether edge-to-edge technique improves clinical and
      hemodynamic results in patients scheduled to septal myectomy for severely symptomatic
      hypertrophic obstructive cardiomyopathy.
A randomised controlled pilot trial to evaluate whether edge-to-edge technique improves
      clinical and hemodynamic results in patients scheduled to septal myectomy for severely
      symptomatic hypertrophic obstructive cardiomyopathy. Patients with proven hypertrophic
      cardiomyopathy and resting left ventricle outflow tract obstruction underwent septal
      myectomy. If patients were suitable for both surgical techniques, they were randomized to
      septal myectomy + edge-to-edge mitral valve repair or isolated septal myectomy. All surgeons
      were experienced at least 50 related procedures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized clinical trial comparing mitral valve repair using the edge-to-edge technique for surgical treatment of hypertrophic cardiomyopathy
primary purpose: Treatment
masking: None (Open Label)
masking description: no data
measure: Left Ventricular Outflow Tract (LVOT) gradient
time frame: 12 months in the medium-term follow-up
description: Gradient at the level of the output section of the left ventricle after surgery (mmHg) This measurement will be performed by transthoracic echocardiography at rest and / or during exercise. The Doppler method will be used.
measure: Systolic anterior motion of the mitral valve
time frame: 12 months in the medium-term follow-up
description: Systolic anterior motion of the mitral valve after surgery This measurement will be performed by transthoracic echocardiography at rest and / or during exercise.
arm group label: isolated septal myectomy
arm group type: Other
description: Isolated extended septal myectomy
arm group label: Septal myectomy+ "edge-to-edge"
arm group type: Active Comparator
description: advanced septal myectomy in combination with mitral valve repair using the edge-to-edge technique
intervention type: Procedure
intervention name: mitral valve repair by edge-to-edge technique
description: transaortic access for mitral valve repair edge-to-edge
arm group label: Septal myectomy+ "edge-to-edge"
other name: Alfieri stitch
intervention type: Procedure
intervention name: Septal myectomy
description: isolated extended septal myectomy
arm group label: isolated septal myectomy
other name: Septal myectomy (SM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Alexander V. Bogachev-Prokophiev, MD, PhD
role: Principal Investigator
affiliation: E.Meshalkin National medical research center
last name: Alexander V. Bogachev-Prokophiev, MD, PhD
phone: +73833476029
email: bogachev.prokophiev@gmail.com
last name: Sergei A. Budagaev
phone: +73833476029
email: ser.bud.med@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Hypertrophic
mesh term: Hypertrophy