<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/NCT04415138</url>
  </required_header>
  <id_info>
    <org_study_id>GAV 213/20</org_study_id>
    <nct_id>NCT04415138</nct_id>
  </id_info>
  <brief_title>Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System</brief_title>
  <official_title>Prospective Evaluation of Robotic-assisted Mitral Surgery With the daVinci X Surgical System: HUMANITAS Gavazzeni Contribution (Studio Dell'Applicazione Della Chirurgia Robotica Con Robot daVinci X (IS4200) di Ultima Generazione Sulla Valvulopatia Mitralica: Contributo di HUMANITAS Gavazzeni)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniche Humanitas Gavazzeni</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniche Humanitas Gavazzeni</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Robotic assistance allows performance of mitral valve operations with a truly minimally&#xD;
      invasive and totally thoracoscopic approach, with significant advantages for patients&#xD;
      compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1)&#xD;
      significant learning curve and technical requirements; 2) increased immediate financial costs&#xD;
      due to dedicated equipment and materials. The aim of the present study is to perform a&#xD;
      prospective data collection and evaluation of the in-hospital and follow-up clinical results&#xD;
      of mitral valve repair using the last generation DaVinci X robotic platform. A&#xD;
      cost-effectiveness analysis of this approach will be also conducted, under a global&#xD;
      healthcare system perspective (including the overall patients' pathway starting from&#xD;
      diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since&#xD;
      the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery,&#xD;
      but instead by minimally invasive, video-assisted mitral surgery, patients operated on using&#xD;
      such technique will serve as controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In an observational, prospective, case-control investigation, the clinical data of all adult&#xD;
      (18 years-old or more) patients undergoing robotic-assisted mitral surgery in the Sponsor&#xD;
      hospital during the study period will be collected, including preoperative, intraoperative&#xD;
      and early postoperative variables. Patients need to be affected by severe mitral&#xD;
      regurgitation due to degenerative lesions and be eligible to robotic-assisted surgery. An&#xD;
      informed consent for inclusion in the study and management of personal data will be asked&#xD;
      from all participants. A total of 30 Baseline variables, 9 intraoperative variables, 26 early&#xD;
      postoperative variables and 55 follow-up variables will be collected. Systematic in-house&#xD;
      follow-up (clinical and echocardiographic) will be performed at the 3rd, 6th and 12th&#xD;
      postoperative months. The database will be managed by research assistants under the&#xD;
      supervision of the surgical team. Operations will be performed according to the Institutional&#xD;
      protocol using the DaVinci X robotic platform by a trained multidisciplinary team including&#xD;
      cardiac surgeons, anesthesiologists, cardiologists, perfusionists and scrub nurses.&#xD;
&#xD;
      The same data will be obtained for all patients undergoing minimally invasive, video-assisted&#xD;
      non-robotic-assisted mitral repair during the study period. These patients will serve as&#xD;
      controls.&#xD;
&#xD;
      Study Endpoints will include procedural success, early postoperative complications,&#xD;
      postoperative functional recovery (both immediate and at follow-up), echocardiographic&#xD;
      results of mitral repair.&#xD;
&#xD;
      Such data will be compared with those from control patients undergoing minimally invasive,&#xD;
      non-robotic-assisted mitral surgery in our Department during the study period.&#xD;
&#xD;
      In cooperation with Hospital Administration Team, all direct and indirect costs (Euros)&#xD;
      associated with the in-hospital pathway of each individual patient will be quantified (17&#xD;
      variables per patient within a separate database). Data collection will be expanded to any&#xD;
      hospitalisation occurring during the 1st postoperative year. Such data collection will&#xD;
      include patients undergoing both the robotic-assisted and the minimally invasive&#xD;
      video-assisted non-robotic-assisted strategy.&#xD;
&#xD;
      Data will be analysed using intergoup comparison statistical tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 10, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Duration of ICU stay (hours) and Hospital stay (days and hours)</measure>
    <time_frame>Up to 30 days after index surgery.</time_frame>
    <description>Duration of stay inside healthcare facility providing index operation. Average value and standard deviation will be presented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)</measure>
    <time_frame>Day of index surgery until 30th postoperative day or discharge</time_frame>
    <description>Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Economic evaluation (direct and indirect costs).</measure>
    <time_frame>Up to 90 days after index surgery.</time_frame>
    <description>Direct and indirect costs associated with robotic-assisted mitral surgery. These will be evaluated for each individual patient and expressed in Euros, under the form of average value and standard deviation. Direct costs will be categorized as follows: total supplies, total drugs, unit operating costs, unit supporting costs).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of residual mitral regurgitation (Early).</measure>
    <time_frame>Up to 60 days after index surgery.</time_frame>
    <description>Data will be obtained from pre-discharge echocardiography. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of residual mitral regurgitation (follow-up).</measure>
    <time_frame>From the 3rd until the 12th month after index surgery.</time_frame>
    <description>Data will be obtained from echocardiography performed at the 3rd, 6th and 12th postoperative months. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Mitral Regurgitation</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Robotic-assisted Group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Video-assisted Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Robotic-assisted mitral valve repair</intervention_name>
    <description>Mitral valve repair using robotic technology (DaVinci X platform)</description>
    <arm_group_label>Robotic-assisted Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients affected by severe mitral regurgitation due to degenerative disease (Leaflet&#xD;
        prolapse/flail) with indication to surgical mitral repair using either a robotic-assisted&#xD;
        approach or a minimally invasive video-assisted non-robotic-assisted approach. Includes&#xD;
        patients referred to a tertiary cardiac surgical centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged at least 18, willing to complete the study follow-up, having signed the informed&#xD;
             consent for participation and data management.&#xD;
&#xD;
          -  Severe mitral regurgitation due to degenerative disease with indication to mitral&#xD;
             repair surgery.&#xD;
&#xD;
          -  If of female gender, being neither pregnant nor lactating.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous right chest surgery or severe right intrapleural adhesions.&#xD;
&#xD;
          -  Diameter of femoral arteries equal or lesser than 6 mm.&#xD;
&#xD;
          -  Left ventricular systolic dysfunction (LVEF &lt;60%).&#xD;
&#xD;
          -  Severe right ventricular dysfunction.&#xD;
&#xD;
          -  Aortic valve regurgitation &gt;1+/4+.&#xD;
&#xD;
          -  Pulmonary artery hypertension (PASP &gt;50 mmHg).&#xD;
&#xD;
          -  Chest deformities preventing either robotic-assisted or minimally invasive&#xD;
             video-assisted surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniche HUMANITAS Gavazzeni</name>
      <address>
        <city>Bergamo</city>
        <zip>24125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Nifong LW, Chitwood WR, Pappas PS, Smith CR, Argenziano M, Starnes VA, Shah PM. Robotic mitral valve surgery: a United States multicenter trial. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1395-404. doi: 10.1016/j.jtcvs.2004.07.050.</citation>
    <PMID>15942584</PMID>
  </results_reference>
  <results_reference>
    <citation>Agnino A, Parrinello M, Panisi P, Anselmi A. Novel nonresectional posterior leaflet remodeling approach for minimally invasive mitral repair. J Thorac Cardiovasc Surg. 2017 Oct;154(4):1247-1249. doi: 10.1016/j.jtcvs.2017.04.076. Epub 2017 May 23. No abstract available.</citation>
    <PMID>28606395</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodriguez E, Nifong LW, Bonatti J, Casula R, Falk V, Folliguet TA, Kiaii BB, Mack MJ, Mihaljevic T, Smith JM, Suri RM, Bavaria JE, MacGillivray TE, Chitwood WR Jr. Pathway for surgeons and programs to establish and maintain a successful robot-assisted adult cardiac surgery program. J Thorac Cardiovasc Surg. 2016 Jul;152(1):9-13. doi: 10.1016/j.jtcvs.2016.05.018. No abstract available.</citation>
    <PMID>27343904</PMID>
  </results_reference>
  <results_reference>
    <citation>Gillinov AM, Mihaljevic T, Javadikasgari H, Suri RM, Mick SL, Navia JL, Desai MY, Bonatti J, Khosravi M, Idrees JJ, Lowry AM, Blackstone EH, Svensson LG. Early results of robotically assisted mitral valve surgery: Analysis of the first 1000 cases. J Thorac Cardiovasc Surg. 2018 Jan;155(1):82-91.e2. doi: 10.1016/j.jtcvs.2017.07.037. Epub 2017 Aug 1.</citation>
    <PMID>28893396</PMID>
  </results_reference>
  <results_reference>
    <citation>Hawkins RB, Mehaffey JH, Mullen MG, Nifong WL, Chitwood WR, Katz MR, Quader MA, Kiser AC, Speir AM, Ailawadi G; Investigators for the Virginia Cardiac Services Quality Initiative. A propensity matched analysis of robotic, minimally invasive, and conventional mitral valve surgery. Heart. 2018 Dec;104(23):1970-1975. doi: 10.1136/heartjnl-2018-313129. Epub 2018 Jun 18.</citation>
    <PMID>29915143</PMID>
  </results_reference>
  <results_reference>
    <citation>Suri RM, Thompson JE, Burkhart HM, Huebner M, Borah BJ, Li Z, Michelena HI, Visscher SL, Roger VL, Daly RC, Cook DJ, Enriquez-Sarano M, Schaff HV. Improving affordability through innovation in the surgical treatment of mitral valve disease. Mayo Clin Proc. 2013 Oct;88(10):1075-84. doi: 10.1016/j.mayocp.2013.06.022.</citation>
    <PMID>24079678</PMID>
  </results_reference>
  <results_reference>
    <citation>Agnino A, Antonazzo A, Albano G, Panisi P, Gerometta P, Piti A, Anselmi A. Strategy-specific durability of mitral valve repair through the video-assisted right minithoracotomy approach. J Cardiovasc Med (Hagerstown). 2019 Mar;20(3):137-144. doi: 10.2459/JCM.0000000000000753.</citation>
    <PMID>30601192</PMID>
  </results_reference>
  <results_reference>
    <citation>Agnino A, Graniero A, Roscitano C, Villari N, Marvelli A, Verhoye JP, Anselmi A. Continued follow-up of the free margin running suture technique for mitral repair. Eur J Cardiothorac Surg. 2020 Oct 1;58(4):847-854. doi: 10.1093/ejcts/ezaa122.</citation>
    <PMID>32380519</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 30, 2020</last_update_submitted>
  <last_update_submitted_qc>May 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cliniche Humanitas Gavazzeni</investigator_affiliation>
    <investigator_full_name>Alfonso Agnino</investigator_full_name>
    <investigator_title>MD, Director of Robotic and Video-Assisted Cardiac Surgery Division</investigator_title>
  </responsible_party>
  <keyword>Robotic Surgery</keyword>
  <keyword>Outcomes</keyword>
  <keyword>Cost analysis</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>Undecided</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/NCT04415138
org study id: GAV 213/20
nct id: NCT04415138
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Robotic assistance allows performance of mitral valve operations with a truly minimally
      invasive and totally thoracoscopic approach, with significant advantages for patients
      compared to sternotomy-based surgery. Nonetheless, its diffusion has been limited by: 1)
      significant learning curve and technical requirements; 2) increased immediate financial costs
      due to dedicated equipment and materials. The aim of the present study is to perform a
      prospective data collection and evaluation of the in-hospital and follow-up clinical results
      of mitral valve repair using the last generation DaVinci X robotic platform. A
      cost-effectiveness analysis of this approach will be also conducted, under a global
      healthcare system perspective (including the overall patients' pathway starting from
      diagnosis of mitral valve disease until the completion of the 1st postoperative year). Since
      the 'competitor' surgical technique is not represented by sternotomy-based mitral surgery,
      but instead by minimally invasive, video-assisted mitral surgery, patients operated on using
      such technique will serve as controls.
In an observational, prospective, case-control investigation, the clinical data of all adult
      (18 years-old or more) patients undergoing robotic-assisted mitral surgery in the Sponsor
      hospital during the study period will be collected, including preoperative, intraoperative
      and early postoperative variables. Patients need to be affected by severe mitral
      regurgitation due to degenerative lesions and be eligible to robotic-assisted surgery. An
      informed consent for inclusion in the study and management of personal data will be asked
      from all participants. A total of 30 Baseline variables, 9 intraoperative variables, 26 early
      postoperative variables and 55 follow-up variables will be collected. Systematic in-house
      follow-up (clinical and echocardiographic) will be performed at the 3rd, 6th and 12th
      postoperative months. The database will be managed by research assistants under the
      supervision of the surgical team. Operations will be performed according to the Institutional
      protocol using the DaVinci X robotic platform by a trained multidisciplinary team including
      cardiac surgeons, anesthesiologists, cardiologists, perfusionists and scrub nurses.

      The same data will be obtained for all patients undergoing minimally invasive, video-assisted
      non-robotic-assisted mitral repair during the study period. These patients will serve as
      controls.

      Study Endpoints will include procedural success, early postoperative complications,
      postoperative functional recovery (both immediate and at follow-up), echocardiographic
      results of mitral repair.

      Such data will be compared with those from control patients undergoing minimally invasive,
      non-robotic-assisted mitral surgery in our Department during the study period.

      In cooperation with Hospital Administration Team, all direct and indirect costs (Euros)
      associated with the in-hospital pathway of each individual patient will be quantified (17
      variables per patient within a separate database). Data collection will be expanded to any
      hospitalisation occurring during the 1st postoperative year. Such data collection will
      include patients undergoing both the robotic-assisted and the minimally invasive
      video-assisted non-robotic-assisted strategy.

      Data will be analysed using intergoup comparison statistical tests.
observational model: Case-Control
time perspective: Prospective
measure: Duration of ICU stay (hours) and Hospital stay (days and hours)
time frame: Up to 30 days after index surgery.
description: Duration of stay inside healthcare facility providing index operation. Average value and standard deviation will be presented.
measure: Rate of Major Adverse Cerebral and Cardiovascular Events (MACCE)
time frame: Day of index surgery until 30th postoperative day or discharge
description: Rate of stroke/TIA, myocardial infarction, cardiac reoperation (presented through both individual and aggregated rates).
measure: Economic evaluation (direct and indirect costs).
time frame: Up to 90 days after index surgery.
description: Direct and indirect costs associated with robotic-assisted mitral surgery. These will be evaluated for each individual patient and expressed in Euros, under the form of average value and standard deviation. Direct costs will be categorized as follows: total supplies, total drugs, unit operating costs, unit supporting costs).
measure: Rate of residual mitral regurgitation (Early).
time frame: Up to 60 days after index surgery.
description: Data will be obtained from pre-discharge echocardiography. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.
measure: Rate of residual mitral regurgitation (follow-up).
time frame: From the 3rd until the 12th month after index surgery.
description: Data will be obtained from echocardiography performed at the 3rd, 6th and 12th postoperative months. Residual Mitral Regurgitation is defined as being at least of degree 2+/4+ according to current Echocardiography recommendations.
arm group label: Robotic-assisted Group
arm group label: Video-assisted Group
intervention type: Device
intervention name: Robotic-assisted mitral valve repair
description: Mitral valve repair using robotic technology (DaVinci X platform)
arm group label: Robotic-assisted Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
citation: Nifong LW, Chitwood WR, Pappas PS, Smith CR, Argenziano M, Starnes VA, Shah PM. Robotic mitral valve surgery: a United States multicenter trial. J Thorac Cardiovasc Surg. 2005 Jun;129(6):1395-404. doi: 10.1016/j.jtcvs.2004.07.050.
PMID: 15942584
citation: Agnino A, Parrinello M, Panisi P, Anselmi A. Novel nonresectional posterior leaflet remodeling approach for minimally invasive mitral repair. J Thorac Cardiovasc Surg. 2017 Oct;154(4):1247-1249. doi: 10.1016/j.jtcvs.2017.04.076. Epub 2017 May 23. No abstract available.
PMID: 28606395
citation: Rodriguez E, Nifong LW, Bonatti J, Casula R, Falk V, Folliguet TA, Kiaii BB, Mack MJ, Mihaljevic T, Smith JM, Suri RM, Bavaria JE, MacGillivray TE, Chitwood WR Jr. Pathway for surgeons and programs to establish and maintain a successful robot-assisted adult cardiac surgery program. J Thorac Cardiovasc Surg. 2016 Jul;152(1):9-13. doi: 10.1016/j.jtcvs.2016.05.018. No abstract available.
PMID: 27343904
citation: Gillinov AM, Mihaljevic T, Javadikasgari H, Suri RM, Mick SL, Navia JL, Desai MY, Bonatti J, Khosravi M, Idrees JJ, Lowry AM, Blackstone EH, Svensson LG. Early results of robotically assisted mitral valve surgery: Analysis of the first 1000 cases. J Thorac Cardiovasc Surg. 2018 Jan;155(1):82-91.e2. doi: 10.1016/j.jtcvs.2017.07.037. Epub 2017 Aug 1.
PMID: 28893396
citation: Hawkins RB, Mehaffey JH, Mullen MG, Nifong WL, Chitwood WR, Katz MR, Quader MA, Kiser AC, Speir AM, Ailawadi G; Investigators for the Virginia Cardiac Services Quality Initiative. A propensity matched analysis of robotic, minimally invasive, and conventional mitral valve surgery. Heart. 2018 Dec;104(23):1970-1975. doi: 10.1136/heartjnl-2018-313129. Epub 2018 Jun 18.
PMID: 29915143
citation: Suri RM, Thompson JE, Burkhart HM, Huebner M, Borah BJ, Li Z, Michelena HI, Visscher SL, Roger VL, Daly RC, Cook DJ, Enriquez-Sarano M, Schaff HV. Improving affordability through innovation in the surgical treatment of mitral valve disease. Mayo Clin Proc. 2013 Oct;88(10):1075-84. doi: 10.1016/j.mayocp.2013.06.022.
PMID: 24079678
citation: Agnino A, Antonazzo A, Albano G, Panisi P, Gerometta P, Piti A, Anselmi A. Strategy-specific durability of mitral valve repair through the video-assisted right minithoracotomy approach. J Cardiovasc Med (Hagerstown). 2019 Mar;20(3):137-144. doi: 10.2459/JCM.0000000000000753.
PMID: 30601192
citation: Agnino A, Graniero A, Roscitano C, Villari N, Marvelli A, Verhoye JP, Anselmi A. Continued follow-up of the free margin running suture technique for mitral repair. Eur J Cardiothorac Surg. 2020 Oct 1;58(4):847-854. doi: 10.1093/ejcts/ezaa122.
PMID: 32380519
responsible party type: Principal Investigator
investigator affiliation: Cliniche Humanitas Gavazzeni
investigator full name: Alfonso Agnino
investigator title: MD, Director of Robotic and Video-Assisted Cardiac Surgery Division
mesh term: Mitral Valve Insufficiency
sharing ipd: Undecided