<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/NCT03038204</url>
  </required_header>
  <id_info>
    <org_study_id>FederalCCS 001</org_study_id>
    <nct_id>NCT03038204</nct_id>
  </id_info>
  <brief_title>The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation</brief_title>
  <acronym>PMA</acronym>
  <official_title>The Papillary Muscle Approximation Provide Stability of Mitral Valve Repair for Ischemic Mitral Regurgitation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for&#xD;
      secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these&#xD;
      procedures is the papillary muscles approximation. However, the safety and the positive&#xD;
      impact of this method are still in doubt.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction.&#xD;
      Among several surgical procedures, mitral ring annuloplasty has been the method of choice for&#xD;
      a considerable period. However, mitral regurgitation recurrence after surgery has a reported&#xD;
      occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying&#xD;
      recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory&#xD;
      outcomes. The pathophysiology of IMR is complex and results from the imbalance between&#xD;
      closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular&#xD;
      chamber, and displacement of papillary muscles in apical and lateral direction increase the&#xD;
      tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial&#xD;
      contractility decrease closing forces, which lead to impaired leaflet coaptation and&#xD;
      appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an&#xD;
      integrated approach affecting all units of the pathogenesis of MR recurrence.&#xD;
&#xD;
      Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for&#xD;
      secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these&#xD;
      procedures is the papillary muscles approximation. However, the safety and the positive&#xD;
      impact of this method are still in doubt. This study is conducted to identify the positive&#xD;
      qualities and safety of this technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Mitral regurgitation severity (1,2 or 3)</measure>
    <time_frame>1 year</time_frame>
    <description>Mitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of left ventricular dimensions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ejection fraction (%)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of myocardial contractility.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of the impact of the surgery on the mitral valve configuration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tenting area (mm^2)</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment of the impact of the surgery on the configuration of the mitral valve.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Age (years)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Body mass index (kg/m^2)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Body surface area (m^2)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>NYHA (I, II, III or IV)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>EuroSCORE</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Six minute walk test (m)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypertension (absence, stage 1, 2 or 3)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients. Impact of the factor on the long-term survival.</description>
  </other_outcome>
  <other_outcome>
    <measure>Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients. Impact of the factor on the long-term survival.</description>
  </other_outcome>
  <other_outcome>
    <measure>Obesity (absence, class 1, 2 or 3)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients. Impact of the factor on the long-term survival.</description>
  </other_outcome>
  <other_outcome>
    <measure>Multifocal atherosclerosis (presence or absence)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients. Impact of the factor on the long-term survival.</description>
  </other_outcome>
  <other_outcome>
    <measure>COPD (absence, GOLD 1, 2, 3 or 4)</measure>
    <time_frame>1 year</time_frame>
    <description>Description and comparison of groups of patients. Impact of the factor on the long-term survival.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Mitral Regurgitation</condition>
  <arm_group>
    <arm_group_label>PMA+MVA+CABG</arm_group_label>
    <description>patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MVA+CABG</arm_group_label>
    <description>patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The papillary muscle approximation</intervention_name>
    <description>Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution.&#xD;
After coronary anastomosis, the mitral valve is exposed by a transseptal incision.&#xD;
The papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose.&#xD;
Annuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured.</description>
    <arm_group_label>PMA+MVA+CABG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with ischemic cardiomyopathy and coexisting IMR were enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ischemic cardiomyopathy,&#xD;
&#xD;
          -  Ischemic mitral regurgitation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Degenerative mitral valve disease,&#xD;
&#xD;
          -  Unstable angina,&#xD;
&#xD;
          -  Recent myocardial infarction (&lt; 6 months),&#xD;
&#xD;
          -  Papillary muscles rupture,&#xD;
&#xD;
          -  Severe right ventricular dysfunction,&#xD;
&#xD;
          -  Multiple organ failures,&#xD;
&#xD;
          -  Concomitant left ventricular reconstruction,&#xD;
&#xD;
          -  Aortic valve procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Manabe S, Shimokawa T, Fukui T, Tabata M, Takanashi S. Impact of papillary muscle approximation on mitral valve configuration in the surgical correction of ischemic mitral regurgitation. Thorac Cardiovasc Surg. 2012 Jun;60(4):269-74. doi: 10.1055/s-0032-1304536. Epub 2012 May 1.</citation>
    <PMID>22549757</PMID>
  </reference>
  <results_reference>
    <citation>Roshanali F, Vedadian A, Shoar S, Naderan M, Mandegar MH. Efficacy of papillary muscle approximation in preventing functional mitral regurgitation recurrence in high-risk patients with ischaemic cardiomyopathy and mitral regurgitation. Acta Cardiol. 2013 Jun;68(3):271-8. doi: 10.1080/ac.68.3.2983421.</citation>
    <PMID>23882872</PMID>
  </results_reference>
  <results_reference>
    <citation>Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6.</citation>
    <PMID>25500293</PMID>
  </results_reference>
  <results_reference>
    <citation>Rama A, Praschker L, Barreda E, Gandjbakhch I. Papillary muscle approximation for functional ischemic mitral regurgitation. Ann Thorac Surg. 2007 Dec;84(6):2130-1. doi: 10.1016/j.athoracsur.2007.04.056.</citation>
    <PMID>18036963</PMID>
  </results_reference>
  <results_reference>
    <citation>Ishikawa S, Ueda K, Kawasaki A, Neya K, Suzuki H. Papillary muscle sandwich plasty for ischemic mitral regurgitation: a new simple technique. J Thorac Cardiovasc Surg. 2008 Jun;135(6):1384-6. doi: 10.1016/j.jtcvs.2007.12.034. No abstract available.</citation>
    <PMID>18544392</PMID>
  </results_reference>
  <results_reference>
    <citation>Yamaguchi A, Adachi K, Yuri K, Kimura N, Kimura C, Tamura A, Adachi H. Reduction of mitral valve leaflet tethering by procedures targeting the subvalvular apparatus in addition to mitral annuloplasty. Circ J. 2013;77(6):1461-5. doi: 10.1253/circj.cj-12-1148. Epub 2013 Feb 20.</citation>
    <PMID>23428660</PMID>
  </results_reference>
  <results_reference>
    <citation>Wakasa S, Kubota S, Shingu Y, Ooka T, Tachibana T, Matsui Y. The extent of papillary muscle approximation affects mortality and durability of mitral valve repair for ischemic mitral regurgitation. J Cardiothorac Surg. 2014 Jun 3;9:98. doi: 10.1186/1749-8090-9-98.</citation>
    <PMID>24893928</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>January 28, 2017</last_update_submitted>
  <last_update_submitted_qc>January 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 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>Papillary muscles approximation</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>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/NCT03038204
org study id: FederalCCS 001
nct id: NCT03038204
lead sponsor: 
has dmc: Yes
Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for
      secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these
      procedures is the papillary muscles approximation. However, the safety and the positive
      impact of this method are still in doubt.
Ischemic mitral regurgitation develops in 10-50% of patients after myocardial infarction.
      Among several surgical procedures, mitral ring annuloplasty has been the method of choice for
      a considerable period. However, mitral regurgitation recurrence after surgery has a reported
      occurrence that ranges from 5% to 58%. Careful consideration of the mechanisms underlying
      recurrence of mitral regurgitation after annuloplasty might explain the unsatisfactory
      outcomes. The pathophysiology of IMR is complex and results from the imbalance between
      closing and tethering forces acting on the mitral valve. Enlargement of the left ventricular
      chamber, and displacement of papillary muscles in apical and lateral direction increase the
      tethering forces. Left ventricular and papillary muscle dyssynchrony, reduced myocardial
      contractility decrease closing forces, which lead to impaired leaflet coaptation and
      appearance of mitral regurgitation. Thus, treatment of mitral insufficiency requires an
      integrated approach affecting all units of the pathogenesis of MR recurrence.

      Recent publications show that an adjunctive subvalvular repair during mitral annuloplasty for
      secondary mitral regurgitation effective in preventing recurrent regurgitation. One of these
      procedures is the papillary muscles approximation. However, the safety and the positive
      impact of this method are still in doubt. This study is conducted to identify the positive
      qualities and safety of this technique.
observational model: Cohort
time perspective: Prospective
measure: Mitral regurgitation severity (1,2 or 3)
time frame: 1 year
description: Mitral regurgitation severity is the main indicator of the effectiveness of mitral valve plasty. Evaluation of mitral regurgitation was performed in accordance with the recommendations of the American Society of Echocardiography (ASE). Recurrence of mitral regurgitation 2 and more was considered as significant.
measure: End-diastolic volume (ml), end-systolic volume (ml), stroke volume (ml)
time frame: 1 year
description: Assessment of left ventricular dimensions.
measure: Ejection fraction (%)
time frame: 1 year
description: Assessment of myocardial contractility.
measure: Systolic interpapillary muscle distance (mm), diastolic interpapillary muscle distance (mm), coaptation depth (mm), coaptation length (mm)
time frame: 1 year
description: Assessment of the impact of the surgery on the mitral valve configuration.
measure: Tenting area (mm^2)
time frame: 1 year
description: Assessment of the impact of the surgery on the configuration of the mitral valve.
measure: Age (years)
time frame: 1 year
description: Description and comparison of groups of patients
measure: Body mass index (kg/m^2)
time frame: 1 year
description: Description and comparison of groups of patients.
measure: Body surface area (m^2)
time frame: 1 year
description: Description and comparison of groups of patients.
measure: NYHA (I, II, III or IV)
time frame: 1 year
description: Description and comparison of groups of patients.
measure: EuroSCORE
time frame: 1 year
description: Description and comparison of groups of patients.
measure: Six minute walk test (m)
time frame: 1 year
description: Description and comparison of groups of patients.
measure: Hypertension (absence, stage 1, 2 or 3)
time frame: 1 year
description: Description and comparison of groups of patients. Impact of the factor on the long-term survival.
measure: Diabetes mellitus (absence, insulin-dependent or noninsulin-dependent)
time frame: 1 year
description: Description and comparison of groups of patients. Impact of the factor on the long-term survival.
measure: Obesity (absence, class 1, 2 or 3)
time frame: 1 year
description: Description and comparison of groups of patients. Impact of the factor on the long-term survival.
measure: Multifocal atherosclerosis (presence or absence)
time frame: 1 year
description: Description and comparison of groups of patients. Impact of the factor on the long-term survival.
measure: COPD (absence, GOLD 1, 2, 3 or 4)
time frame: 1 year
description: Description and comparison of groups of patients. Impact of the factor on the long-term survival.
arm group label: PMA+MVA+CABG
description: patients with ischemic cardiomyopathy and mitral regurgitation who underwent coronary artery bypass grafting, mitral annuloplasty, and papillary muscles approximation.
arm group label: MVA+CABG
description: patients with ischemic cardiomyopathy who underwent coronary artery bypass grafting and mitral valve annuloplasty.
intervention type: Procedure
intervention name: The papillary muscle approximation
description: Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution.
After coronary anastomosis, the mitral valve is exposed by a transseptal incision.
The papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose.
Annuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured.
arm group label: PMA+MVA+CABG
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
citation: Manabe S, Shimokawa T, Fukui T, Tabata M, Takanashi S. Impact of papillary muscle approximation on mitral valve configuration in the surgical correction of ischemic mitral regurgitation. Thorac Cardiovasc Surg. 2012 Jun;60(4):269-74. doi: 10.1055/s-0032-1304536. Epub 2012 May 1.
PMID: 22549757
citation: Roshanali F, Vedadian A, Shoar S, Naderan M, Mandegar MH. Efficacy of papillary muscle approximation in preventing functional mitral regurgitation recurrence in high-risk patients with ischaemic cardiomyopathy and mitral regurgitation. Acta Cardiol. 2013 Jun;68(3):271-8. doi: 10.1080/ac.68.3.2983421.
PMID: 23882872
citation: Kron IL, Hung J, Overbey JR, Bouchard D, Gelijns AC, Moskowitz AJ, Voisine P, O'Gara PT, Argenziano M, Michler RE, Gillinov M, Puskas JD, Gammie JS, Mack MJ, Smith PK, Sai-Sudhakar C, Gardner TJ, Ailawadi G, Zeng X, O'Sullivan K, Parides MK, Swayze R, Thourani V, Rose EA, Perrault LP, Acker MA; CTSN Investigators. Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2015 Mar;149(3):752-61.e1. doi: 10.1016/j.jtcvs.2014.10.120. Epub 2014 Nov 6.
PMID: 25500293
citation: Rama A, Praschker L, Barreda E, Gandjbakhch I. Papillary muscle approximation for functional ischemic mitral regurgitation. Ann Thorac Surg. 2007 Dec;84(6):2130-1. doi: 10.1016/j.athoracsur.2007.04.056.
PMID: 18036963
citation: Ishikawa S, Ueda K, Kawasaki A, Neya K, Suzuki H. Papillary muscle sandwich plasty for ischemic mitral regurgitation: a new simple technique. J Thorac Cardiovasc Surg. 2008 Jun;135(6):1384-6. doi: 10.1016/j.jtcvs.2007.12.034. No abstract available.
PMID: 18544392
citation: Yamaguchi A, Adachi K, Yuri K, Kimura N, Kimura C, Tamura A, Adachi H. Reduction of mitral valve leaflet tethering by procedures targeting the subvalvular apparatus in addition to mitral annuloplasty. Circ J. 2013;77(6):1461-5. doi: 10.1253/circj.cj-12-1148. Epub 2013 Feb 20.
PMID: 23428660
citation: Wakasa S, Kubota S, Shingu Y, Ooka T, Tachibana T, Matsui Y. The extent of papillary muscle approximation affects mortality and durability of mitral valve repair for ischemic mitral regurgitation. J Cardiothorac Surg. 2014 Jun 3;9:98. doi: 10.1186/1749-8090-9-98.
PMID: 24893928
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
mesh term: Mitral Valve Insufficiency
sharing ipd: Yes