<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/NCT03278418</url>
  </required_header>
  <id_info>
    <org_study_id>ESREFO 32</org_study_id>
    <nct_id>NCT03278418</nct_id>
  </id_info>
  <brief_title>Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach</brief_title>
  <acronym>RIGHT</acronym>
  <official_title>Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ettore Sansavini Health Science Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ettore Sansavini Health Science Foundation</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>
      Patients elected to undergo any type of left-sided valve surgery (either repair or&#xD;
      replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be&#xD;
      screened. Consenting patients fulfilling all inclusion and exclusion criteria will be&#xD;
      included in the study and assigned to elective left-sided valve replacement or repair with or&#xD;
      without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization&#xD;
      scheme balanced within center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm&#xD;
      parallel group trial. Participating centres are selected based on previous experience with&#xD;
      the surgical technique and standardised echo imaging. Each center is expected to contribute&#xD;
      70 patients over a 12 months enrolment period.&#xD;
&#xD;
      Patients elected to undergo any type of left-sided valve surgery (either repair or&#xD;
      replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be&#xD;
      screened. Consenting patients fulfilling all inclusion and exclusion criteria will be&#xD;
      included in the study and assigned to elective left-sided valve replacement or repair with or&#xD;
      without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization&#xD;
      scheme balanced within center.&#xD;
&#xD;
      After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Significant TR (moderate or severe)</measure>
    <time_frame>3 years</time_frame>
    <description>To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (&gt;10 cm2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Significant TR (moderate or severe)</measure>
    <time_frame>1 and 2 years</time_frame>
    <description>To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (&gt;10 cm2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mild TR</measure>
    <time_frame>1,2 and 3 years</time_frame>
    <description>To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2) or mild (&lt;5 cm2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall TR (mild, moderate, severe)</measure>
    <time_frame>1, 2 and 3 years</time_frame>
    <description>To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2; mild &lt;5 cm2, moderate = 5-10 cm2), or severe (&gt;10 cm2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RV function</measure>
    <time_frame>1, 2 and 3 years</time_frame>
    <description>To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary Artery Pressure (PAP)</measure>
    <time_frame>1, 2 and 3 years</time_frame>
    <description>To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Tricuspid Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Tricuspid Valve Repair</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>left-sided valve surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tricuspid Valve Repair</intervention_name>
    <description>It will be performed according to the surgeon preference</description>
    <arm_group_label>Tricuspid Valve Repair</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left-sided valve surgery</intervention_name>
    <description>It will be performed according to the surgeon preference</description>
    <arm_group_label>Tricuspid Valve Repair</arm_group_label>
    <arm_group_label>left-sided valve surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing left-sided valve surgery for left-sided valve disease&#xD;
&#xD;
          -  Presence of non-severe TR and tricuspid annular dilation (&gt;40 mm or &gt; 21 mm/m2 BSA)&#xD;
             determined by echocardiography&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Capability to sign Informed Consent and Release of Medical Information forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative severe TR&#xD;
&#xD;
          -  Structural / organic tricuspid valve disease&#xD;
&#xD;
          -  Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE&#xD;
&#xD;
          -  Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from&#xD;
             the right atrium into the RV&#xD;
&#xD;
          -  Any type of reoperative surgery&#xD;
&#xD;
          -  Concomitant cardiac surgery other than atrial fibrillation correction surgery&#xD;
             (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure&#xD;
             of patent foramen ovale or atrial septal defect (for example, concomitant coronary&#xD;
             artery bypass graft or aortic surgery)&#xD;
&#xD;
          -  Cardiogenic shock at the time of randomization&#xD;
&#xD;
          -  ST-elevated myocardial infarction requiring intervention within 7 days prior to&#xD;
             randomization&#xD;
&#xD;
          -  Evidence of cirrhosis or hepatic synthetic failure&#xD;
&#xD;
          -  Severe, irreversible pulmonary hypertension in the judgment of the investigator&#xD;
&#xD;
          -  Pregnancy at the time of randomization&#xD;
&#xD;
          -  Any concurrent disease with life expectancy &lt; 1 year&#xD;
&#xD;
          -  Patient unable or unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Salomone, MD</last_name>
    <role>Study Director</role>
    <affiliation>Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mauro Del Giglio, MD</last_name>
    <phone>+390545217445</phone>
    <email>mdelgiglio@gvmnet.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Donato Mele, MD</last_name>
    <phone>+393476411190</phone>
    <email>donatomele@libero.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maria Cecilia Hospital</name>
      <address>
        <city>Cotignola</city>
        <state>Ravenna</state>
        <zip>48033</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>Milano</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Alessandro Frigiola, MD, PhD</last_name>
      <phone>+390252774392</phone>
      <email>alessandro.frigiola@grupposandonato.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>IRCCS Opsedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Ottavio Alfieri, MD, PhD</last_name>
      <phone>+390226437102</phone>
      <email>cardiochirurgia@hsr.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Maria Eleonora Hospital</name>
      <address>
        <city>Palermo</city>
        <zip>90135</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Khalil Fattouch, MD, PhD</last_name>
      <phone>+393288105584</phone>
      <email>khalilfattouch@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tricuspid 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/NCT03278418
org study id: ESREFO 32
nct id: NCT03278418
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients elected to undergo any type of left-sided valve surgery (either repair or
      replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be
      screened. Consenting patients fulfilling all inclusion and exclusion criteria will be
      included in the study and assigned to elective left-sided valve replacement or repair with or
      without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization
      scheme balanced within center.
The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm
      parallel group trial. Participating centres are selected based on previous experience with
      the surgical technique and standardised echo imaging. Each center is expected to contribute
      70 patients over a 12 months enrolment period.

      Patients elected to undergo any type of left-sided valve surgery (either repair or
      replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be
      screened. Consenting patients fulfilling all inclusion and exclusion criteria will be
      included in the study and assigned to elective left-sided valve replacement or repair with or
      without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization
      scheme balanced within center.

      After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Significant TR (moderate or severe)
time frame: 3 years
description: To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).
measure: Significant TR (moderate or severe)
time frame: 1 and 2 years
description: To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2).
measure: Mild TR
time frame: 1,2 and 3 years
description: To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2) or mild (<5 cm2).
measure: Overall TR (mild, moderate, severe)
time frame: 1, 2 and 3 years
description: To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2; mild <5 cm2, moderate = 5-10 cm2), or severe (>10 cm2).
measure: RV function
time frame: 1, 2 and 3 years
description: To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters.
measure: Pulmonary Artery Pressure (PAP)
time frame: 1, 2 and 3 years
description: To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP)
measure: Event free survival
time frame: 3 years
description: Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests
arm group label: Tricuspid Valve Repair
arm group type: Experimental
description: Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
arm group label: left-sided valve surgery
arm group type: Active Comparator
description: No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery
intervention type: Procedure
intervention name: Tricuspid Valve Repair
description: It will be performed according to the surgeon preference
arm group label: Tricuspid Valve Repair
intervention type: Procedure
intervention name: Left-sided valve surgery
description: It will be performed according to the surgeon preference
arm group label: Tricuspid Valve Repair
arm group label: left-sided valve surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Maria Salomone, MD
role: Study Director
affiliation: Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
last name: Mauro Del Giglio, MD
phone: +390545217445
email: mdelgiglio@gvmnet.it
last name: Donato Mele, MD
phone: +393476411190
email: donatomele@libero.it
facility: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Tricuspid Valve Insufficiency
sharing ipd: No