<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/NCT02996552</url>
  </required_header>
  <id_info>
    <org_study_id>072/11</org_study_id>
    <nct_id>NCT02996552</nct_id>
  </id_info>
  <brief_title>Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)</brief_title>
  <acronym>NOSTRUM</acronym>
  <official_title>Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Spontaneous, Multicentre, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ospedale San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ospedale San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR)&#xD;
      in patient undergoing mitral valve surgery, is still controversial: some observational&#xD;
      studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral&#xD;
      valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit,&#xD;
      while in other observational studies such benefit has not been documented.&#xD;
&#xD;
      The ESC Guidelines assign the class IIa recommendation for surgical treatment in patients&#xD;
      with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the&#xD;
      repair or replacement of the mitral valve. However the level of evidence C (expert opinion)&#xD;
      confirms the absence of clear scientific evidence to support this recommendation.&#xD;
&#xD;
      It is therefore very important to carry out randomized trials designed to really prove the&#xD;
      supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with&#xD;
      degenerative etiology where the data are particularly controversial.&#xD;
&#xD;
      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in&#xD;
      the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation&#xD;
      undergoing mitral valve repair.&#xD;
&#xD;
      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2&#xD;
      degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment&#xD;
      by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of&#xD;
      combined treatment (M &amp; T Repair Group) compared to single treatment (Mitral-Only Group) at 5&#xD;
      and 10 years after surgery.&#xD;
&#xD;
      This will be an experimental superiority, prospective, spontaneous, multicenter, randomized&#xD;
      trial.&#xD;
&#xD;
      Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1&#xD;
      stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and&#xD;
      tricuspid repair (M &amp; T Repair group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current guidelines recommend surgical treatment of secondary tricuspid regurgitation (TR) in&#xD;
      patients with mild or moderate TR undergoing mitral valve (MV) surgery if significant&#xD;
      dilatation of the tricuspid annulus is documented. Indeed, several observational series and&#xD;
      small randomized studies have shown that in the presence of tricuspid annulus dilatation, not&#xD;
      treating less than severe secondary TR may lead to progression of the tricuspid disease&#xD;
      despite correction of the associated left-sided lesion.&#xD;
&#xD;
      However, the level of evidence C (expert opinion) confirms the absence of clear scientific&#xD;
      evidence to support this recommendation.&#xD;
&#xD;
      It is therefore very important to carry out randomized trials designed to really prove the&#xD;
      supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with&#xD;
      degenerative etiology where the data are particularly controversial.&#xD;
&#xD;
      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in&#xD;
      the early stage. The investigators enrolled patient with TR≤2+ and annular dilation&#xD;
      undergoing mitral valve repair.&#xD;
&#xD;
      This will be a multicenter single-blind parallel group randomized controlled trial. Patients&#xD;
      will be randomly assigned to two parallel arms with an allocation ratio 1:1, to receive one&#xD;
      of two surgical procedures. Patients that will match the inclusion criteria at the&#xD;
      preoperative evaluation will be recruited.&#xD;
&#xD;
      Patient will be randomized according to a computer-generated list of casual numbers.&#xD;
      Information about patient allocation will be kept in closed opaque envelopes and nobody will&#xD;
      know patient allocation before randomization. Patients will be blind to allocation.&#xD;
&#xD;
      The day of surgery patients will be subsequently randomized into two arms with an allocation&#xD;
      ratio 1:1 stratified by center, to receive:&#xD;
&#xD;
        1. M &amp; T Repair Group&#xD;
&#xD;
        2. Mitral-Only Group Each group will consist of 71 patients. All patients will receive the&#xD;
           mitral valve repair and in patients enrolled in the M &amp; T Repair Group an Edwards MC3&#xD;
           Tricuspid ring will be implanted.&#xD;
&#xD;
      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2&#xD;
      degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment&#xD;
      by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of&#xD;
      combined treatment (M &amp; T Repair Group) compared to single treatment (Mitral-Only Group) at 5&#xD;
      and 10 years after surgery.&#xD;
&#xD;
      For statistical analysis the data will be expressed as &quot;average ± standard deviation&quot; or as&#xD;
      percentage. A &quot;probability value&quot; less than 0.05 will be considered as &quot;statistically&#xD;
      significant.&quot; Outcomes will be compared using the &quot;X2&quot; analysis for categorical variables and&#xD;
      the &quot;t-test&quot; for the continuous onces. The data will be analyzed using SPSS version 11.5&#xD;
      (SPSS Inc., Chicago, IL, USA) for Windows (Microsoft Corp, Redmond, WA). Survival and freedom&#xD;
      from reoperation, freedom from TR≥3+ or from a progression of TR of at least 2 grades (as&#xD;
      compared to baseline), will be analyzed by the method of Kaplan-Meier. The analysis&#xD;
      &quot;univariate&quot; and possibly &quot;multivariate&quot; of risk factors will be performed with &quot;Cox&#xD;
      proportional hazards regression&quot;.&#xD;
&#xD;
      The Fine and Gray model will be used in a &quot;competing risk analysis&quot; for &quot;time to TR ≥ 3+/4+&quot;&#xD;
      and &quot;time to TR progression of at least 2 grades compared to baseline&quot; considering the death&#xD;
      event as competitive risk.&#xD;
&#xD;
      In addition, estimates of the respective cumulative incidence (CIF) of these events in the 2&#xD;
      groups will be compared to determine the impact on such endpoints of the execution or&#xD;
      non-execution of tricuspid anuloplasty.&#xD;
&#xD;
      The aim of the study is to demonstrate the superiority of combined mitral and tricuspid&#xD;
      treatment (M &amp; T Repair) compared to isolated mitral repair (Mitral-Only Group) in the&#xD;
      enrolled patients.&#xD;
&#xD;
      The primary end-point is to demonstrate that, at 1 year of follow-up, the recurrence of TR≥3+&#xD;
      or the progression of TR of at least 2 degrees (compared to baseline) occurs in less than 1%&#xD;
      of the patients undergoing both mitral e tricuspid repair (M &amp; T Repair Group). The expected&#xD;
      rate for the Mitral-Only group is 15%. (Power = 80%, alpha = 0.05, Number of Patients per&#xD;
      group = 71).&#xD;
&#xD;
      Secondary endpoints are to demonstrate the superiority of the combined treatment (M &amp; T&#xD;
      Repair Group) compared to the single treatment (Mitral-Only Group) at 5 and 10 years after&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2011</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Actual">June 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The 1-year freedom from recurrence of TR≥3+ and from progression by 2 degrees compared to pre-operative.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The 5-year freedom from recurrence of TR &gt;= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M &amp; T Repair Group) and in the single treatment group ( Mitral-Only Group)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The 10-year freedom from recurrence of TR &gt;= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M &amp; T Repair Group) and in the single treatment group ( Mitral-Only Group)</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">142</enrollment>
  <condition>Tricuspid Disease</condition>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>M &amp; T Repair Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Both mitral and tricuspid valves repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mitral-Only Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Only mitral valve repair</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>M &amp; T Repair Group</intervention_name>
    <description>After the mitral valve repair a device for tricuspid annuloplasty will be implanted.</description>
    <arm_group_label>M &amp; T Repair Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mitral-Only Group</intervention_name>
    <description>Mitral valve repair alone; after the mitral valve repair no device for tricuspid annuloplasty will be implanted.</description>
    <arm_group_label>Mitral-Only Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years;&#xD;
&#xD;
          -  ability to provide informed consent;&#xD;
&#xD;
          -  patients scheduled for mitral valve regurgitation&#xD;
&#xD;
          -  TR ≤ 2+ with annular dilation&#xD;
&#xD;
          -  Tricuspid diastolic diameter ≥ 40 mm or 21 mm/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient's refusal&#xD;
&#xD;
          -  non-elective cardiac surgery;&#xD;
&#xD;
          -  organic disease of tricuspid valve&#xD;
&#xD;
          -  TR≥3&#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>Michele De Bonis, MD,FESC,FAHA</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Ospedale San Raffale Milano</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michele De Bonis, MD,FESC,FAHA</last_name>
    <phone>00390226437118</phone>
    <email>debonis.michele@hsr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cinzia Trumello, MD</last_name>
    <phone>00390226437127</phone>
    <email>trumello.cinzia@hsr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucia Torracca, MD</last_name>
      <phone>00390282244330</phone>
      <email>lucia.torracca@humanitas.it</email>
    </contact>
    <investigator>
      <last_name>Lucia Torracca, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Fumero, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milan</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michele De Bonis, MD</last_name>
      <phone>00390226437118</phone>
      <email>debonis.michele@hsr.it</email>
    </contact>
    <investigator>
      <last_name>Michele De Bonis, MD,FESC,FAHA</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cinzia Trumello, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Teodora Nisi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elisabetta Lapenna, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ottavio Alfieri, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</name>
      <address>
        <city>Warsaw</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piotr Suwalski, MD</last_name>
      <phone>0048225081260</phone>
      <email>suwalski.piotr@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Piotr Suwalski, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ospedale San Raffaele</investigator_affiliation>
    <investigator_full_name>Michele De Bonis</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Tricuspid annulus dilation</keyword>
  <keyword>mitral valve regurgitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</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/NCT02996552
org study id: 072/11
nct id: NCT02996552
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR)
      in patient undergoing mitral valve surgery, is still controversial: some observational
      studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral
      valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit,
      while in other observational studies such benefit has not been documented.

      The ESC Guidelines assign the class IIa recommendation for surgical treatment in patients
      with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the
      repair or replacement of the mitral valve. However the level of evidence C (expert opinion)
      confirms the absence of clear scientific evidence to support this recommendation.

      It is therefore very important to carry out randomized trials designed to really prove the
      supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with
      degenerative etiology where the data are particularly controversial.

      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in
      the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation
      undergoing mitral valve repair.

      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2
      degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment
      by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of
      combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5
      and 10 years after surgery.

      This will be an experimental superiority, prospective, spontaneous, multicenter, randomized
      trial.

      Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1
      stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and
      tricuspid repair (M & T Repair group).
Current guidelines recommend surgical treatment of secondary tricuspid regurgitation (TR) in
      patients with mild or moderate TR undergoing mitral valve (MV) surgery if significant
      dilatation of the tricuspid annulus is documented. Indeed, several observational series and
      small randomized studies have shown that in the presence of tricuspid annulus dilatation, not
      treating less than severe secondary TR may lead to progression of the tricuspid disease
      despite correction of the associated left-sided lesion.

      However, the level of evidence C (expert opinion) confirms the absence of clear scientific
      evidence to support this recommendation.

      It is therefore very important to carry out randomized trials designed to really prove the
      supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with
      degenerative etiology where the data are particularly controversial.

      The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in
      the early stage. The investigators enrolled patient with TR≤2+ and annular dilation
      undergoing mitral valve repair.

      This will be a multicenter single-blind parallel group randomized controlled trial. Patients
      will be randomly assigned to two parallel arms with an allocation ratio 1:1, to receive one
      of two surgical procedures. Patients that will match the inclusion criteria at the
      preoperative evaluation will be recruited.

      Patient will be randomized according to a computer-generated list of casual numbers.
      Information about patient allocation will be kept in closed opaque envelopes and nobody will
      know patient allocation before randomization. Patients will be blind to allocation.

      The day of surgery patients will be subsequently randomized into two arms with an allocation
      ratio 1:1 stratified by center, to receive:

        1. M & T Repair Group

        2. Mitral-Only Group Each group will consist of 71 patients. All patients will receive the
           mitral valve repair and in patients enrolled in the M & T Repair Group an Edwards MC3
           Tricuspid ring will be implanted.

      Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2
      degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment
      by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of
      combined treatment (M & T Repair Group) compared to single treatment (Mitral-Only Group) at 5
      and 10 years after surgery.

      For statistical analysis the data will be expressed as "average ± standard deviation" or as
      percentage. A "probability value" less than 0.05 will be considered as "statistically
      significant." Outcomes will be compared using the "X2" analysis for categorical variables and
      the "t-test" for the continuous onces. The data will be analyzed using SPSS version 11.5
      (SPSS Inc., Chicago, IL, USA) for Windows (Microsoft Corp, Redmond, WA). Survival and freedom
      from reoperation, freedom from TR≥3+ or from a progression of TR of at least 2 grades (as
      compared to baseline), will be analyzed by the method of Kaplan-Meier. The analysis
      "univariate" and possibly "multivariate" of risk factors will be performed with "Cox
      proportional hazards regression".

      The Fine and Gray model will be used in a "competing risk analysis" for "time to TR ≥ 3+/4+"
      and "time to TR progression of at least 2 grades compared to baseline" considering the death
      event as competitive risk.

      In addition, estimates of the respective cumulative incidence (CIF) of these events in the 2
      groups will be compared to determine the impact on such endpoints of the execution or
      non-execution of tricuspid anuloplasty.

      The aim of the study is to demonstrate the superiority of combined mitral and tricuspid
      treatment (M & T Repair) compared to isolated mitral repair (Mitral-Only Group) in the
      enrolled patients.

      The primary end-point is to demonstrate that, at 1 year of follow-up, the recurrence of TR≥3+
      or the progression of TR of at least 2 degrees (compared to baseline) occurs in less than 1%
      of the patients undergoing both mitral e tricuspid repair (M & T Repair Group). The expected
      rate for the Mitral-Only group is 15%. (Power = 80%, alpha = 0.05, Number of Patients per
      group = 71).

      Secondary endpoints are to demonstrate the superiority of the combined treatment (M & T
      Repair Group) compared to the single treatment (Mitral-Only Group) at 5 and 10 years after
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The 1-year freedom from recurrence of TR≥3+ and from progression by 2 degrees compared to pre-operative.
time frame: 1 year
measure: The 5-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group)
time frame: 5 years
measure: The 10-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group)
time frame: 10 years
arm group label: M & T Repair Group
arm group type: Experimental
description: Both mitral and tricuspid valves repair
arm group label: Mitral-Only Group
arm group type: Active Comparator
description: Only mitral valve repair
intervention type: Procedure
intervention name: M & T Repair Group
description: After the mitral valve repair a device for tricuspid annuloplasty will be implanted.
arm group label: M & T Repair Group
intervention type: Procedure
intervention name: Mitral-Only Group
description: Mitral valve repair alone; after the mitral valve repair no device for tricuspid annuloplasty will be implanted.
arm group label: Mitral-Only Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michele De Bonis, MD,FESC,FAHA
role: Principal Investigator
affiliation: IRCCS Ospedale San Raffale Milano
last name: Michele De Bonis, MD,FESC,FAHA
phone: 00390226437118
email: debonis.michele@hsr.it
last name: Cinzia Trumello, MD
phone: 00390226437127
email: trumello.cinzia@hsr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Ospedale San Raffaele
investigator full name: Michele De Bonis
investigator title: Associate Professor
mesh term: Mitral Valve Insufficiency
sharing ipd: No