<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/NCT01708265</url>
  </required_header>
  <id_info>
    <org_study_id>NL39851.041.12.</org_study_id>
    <nct_id>NCT01708265</nct_id>
  </id_info>
  <brief_title>The Dutch Asymptomatic Mitral Regurgitation Trial</brief_title>
  <acronym>Dutch AMR</acronym>
  <official_title>Dutch AMR; Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Organic Mitral Regurgitation; a Multicenter, Randomised Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Interuniversity Cardiology Institute of the Netherlands</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>WCN, Dutch Network for Cardiovascular Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>UMC Utrecht</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare early mitral valve repair versus a watchful waiting&#xD;
      strategy in asymptomatic patients with severe organic mitral valve regurgitation and&#xD;
      preserved left ventricular function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular&#xD;
      (LV) function is a challenging clinical entity as data on the recommended treatment strategy&#xD;
      for these patients are scarce and conflicting, which is reflected in current guidelines.&#xD;
      European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly&#xD;
      echocardiography, whilst American guidelines are more in favour of early surgery to&#xD;
      reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future&#xD;
      LV dysfunction and complaints.&#xD;
&#xD;
      A number of non-randomised trials show a favourable outcome of early surgery and the early&#xD;
      surgery strategy has shown to be associated with improved long-term survival, decreased&#xD;
      cardiac mortality and decreased morbidity compared with the conservative management&#xD;
      [citations 1-3]. On the other hand, non-randomised trials describe also that a conservative&#xD;
      strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is&#xD;
      performed in this population it has proven to be eventually associated with good&#xD;
      perioperative and postoperative outcome in 50% of the patients at 10 years when careful&#xD;
      follow-up is being carried out [citation 4]. Non-randomised trials inherently have a number&#xD;
      of drawbacks. A randomised trial comparing both strategies and objectivising the best&#xD;
      treatment strategy has never been performed.&#xD;
&#xD;
      The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective,&#xD;
      randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients&#xD;
      with severe organic MV regurgitation and preserved LV function [citation 5, 6].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    low inclusion rate&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">February 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>Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>The primary outcome is defined as 'time to first event'. It concerns time to first event of the composite endpoint of cardiovascular mortality, congestive heart failure, non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation (permanent or requiring hospitalization) and/or reoperation after elective MV surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Congestive heart failure</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization for nonfatal cardiovascular events</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of all-cause mortality at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs and effectiveness</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures total direct and indirect costs and cost-effectiveness at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures health-related quality of life at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic parameters</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures echocardiographic parameters at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMR parameters</measure>
    <time_frame>Min. 5 years.</time_frame>
    <description>Secondary outcome measures Cardiovascular Magnetic Resonance imaging (CMR) parameters at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Paroxysmal atrial fibrillation</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of paroxysmal atrial fibrillation at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise test parameters</measure>
    <time_frame>Min. 5 years.</time_frame>
    <description>Secondary outcome measures exercise test parameters at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BNP</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures brain natriuretic peptide (BNP) plasma levels at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of myocardial infarction at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pacemaker implantation</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of pacemaker implantation at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transient ischemic attack</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of transient ischemic attack (TIA) at a minimum of 5 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary embolism</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Secondary outcome measures the incidence of pulmonary embolism at a minimum of 5 years.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Surgery complication rate</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>The complication rate in the mitral valve surgery group (e.g. re-operation for bleeding, pneumonia, residual or recurrent mitral valve regurgitation) will be determined at a minimum of 5 years.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate for the need of facilitated surgery</measure>
    <time_frame>Min. 5 years</time_frame>
    <description>Rate for the need of facilitated surgery in the watchful waiting group will be determined at a minimum of 5 years.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Heart; Disease, Mitral(Valve)</condition>
  <condition>Diseases of Mitral Valve</condition>
  <condition>Mitral Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Early mitral valve repair</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Early mitral valve repair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Watchful waiting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Watchful waiting</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Watchful waiting</intervention_name>
    <description>In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.</description>
    <arm_group_label>Watchful waiting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Early mitral valve repair</intervention_name>
    <description>Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.</description>
    <arm_group_label>Early mitral valve repair</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Asymptomatic&#xD;
&#xD;
          -  Severe organic mitral valve regurgitation.&#xD;
&#xD;
          -  Preserved left ventricular function (left ventricular ejection fraction &gt;60% and left&#xD;
             ventricular end-systolic dimension ≤45 mm)&#xD;
&#xD;
          -  The likelihood of MV repair should be more than 90% determined by the local heart team&#xD;
             with a cardiologist and cardiothoracic surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmonary hypertension (&gt;50 mmHg at rest)&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Physical inability as determined by the heart team to undergo surgery&#xD;
&#xD;
          -  Other life-threatening morbidity&#xD;
&#xD;
          -  Higher expected surgical risks in advance, according to the dedicated heart team&#xD;
&#xD;
          -  Moderate to severe kidney disease (eGFR less than 30 mL/min)&#xD;
&#xD;
          -  Flail leaflet together with a left ventricular end systolic diameter (LVESD) &gt;40 mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven AJ Chamuleau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Utrecht (UMC Utrecht)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jolanda Kluin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Utrecht (UMC Utrecht)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert JM Klautz, Prof. MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Center (LUMC Leiden)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Leiden University Medical Center</name>
      <address>
        <city>Leiden</city>
        <state>South Holland</state>
        <zip>2333 ZA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia Hospital</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht (UMC Utrecht)</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>http://dutchamr.nl/</url>
    <description>Dutch AMR study homepage</description>
  </link>
  <reference>
    <citation>Ling LH, Enriquez-Sarano M, Seward JB, Orszulak TA, Schaff HV, Bailey KR, Tajik AJ, Frye RL. Early surgery in patients with mitral regurgitation due to flail leaflets: a long-term outcome study. Circulation. 1997 Sep 16;96(6):1819-25. doi: 10.1161/01.cir.96.6.1819.</citation>
    <PMID>9323067</PMID>
  </reference>
  <reference>
    <citation>Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.</citation>
    <PMID>15745978</PMID>
  </reference>
  <reference>
    <citation>Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.</citation>
    <PMID>19632855</PMID>
  </reference>
  <reference>
    <citation>Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006 May 9;113(18):2238-44. doi: 10.1161/CIRCULATIONAHA.105.599175. Epub 2006 May 1.</citation>
    <PMID>16651470</PMID>
  </reference>
  <reference>
    <citation>Tietge WJ, de Heer LM, van Hessen MW, Jansen R, Bots ML, van Gilst W, Schalij M, Klautz RJ, Van den Brink RB, Van Herwerden LA, Doevendans PA, Chamuleau SA, Kluin J. Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial. Neth Heart J. 2012 Mar;20(3):94-101. doi: 10.1007/s12471-012-0249-y.</citation>
    <PMID>22354529</PMID>
  </reference>
  <reference>
    <citation>Jansen R, Kluin J, Chamuleau SA. Research versus clinical practice in asymptomatic patients with severe organic mitral regurgitation and preserved LV function. J Am Coll Cardiol. 2014 Oct 14;64(15):1639-40. doi: 10.1016/j.jacc.2014.07.964. No abstract available.</citation>
    <PMID>25301470</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>November 22, 2016</last_update_submitted>
  <last_update_submitted_qc>November 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UMC Utrecht</investigator_affiliation>
    <investigator_full_name>S.A.J. Chamuleau</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Mitral Valve Insufficiency</keyword>
  <keyword>Mitral Valve Regurgitation</keyword>
  <keyword>Asymptomatic Mitral Valve Regurgitation</keyword>
  <keyword>Asymptomatic Mitral Valve Insufficiency</keyword>
  <keyword>Mitral Valve Repair</keyword>
  <keyword>Watchful Waiting</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01708265
org study id: NL39851.041.12.
nct id: NCT01708265
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare early mitral valve repair versus a watchful waiting
      strategy in asymptomatic patients with severe organic mitral valve regurgitation and
      preserved left ventricular function.
Severe asymptomatic organic mitral valve (MV) regurgitation with preserved left ventricular
      (LV) function is a challenging clinical entity as data on the recommended treatment strategy
      for these patients are scarce and conflicting, which is reflected in current guidelines.
      European guidelines advocate a more conservative strategy i.e. watchful waiting, with yearly
      echocardiography, whilst American guidelines are more in favour of early surgery to
      reconstruct the MV, i.e. MV repair (in contrast to MV replacement) in order to prevent future
      LV dysfunction and complaints.

      A number of non-randomised trials show a favourable outcome of early surgery and the early
      surgery strategy has shown to be associated with improved long-term survival, decreased
      cardiac mortality and decreased morbidity compared with the conservative management
      [citations 1-3]. On the other hand, non-randomised trials describe also that a conservative
      strategy (i.e. watchful waiting) can be safely accomplished. If facilitated surgery is
      performed in this population it has proven to be eventually associated with good
      perioperative and postoperative outcome in 50% of the patients at 10 years when careful
      follow-up is being carried out [citation 4]. Non-randomised trials inherently have a number
      of drawbacks. A randomised trial comparing both strategies and objectivising the best
      treatment strategy has never been performed.

      The Dutch AMR (Asymptomatic Mitral Regurgitation) trial is a multicenter, prospective,
      randomised trial comparing early MV repair versus watchful waiting in asymptomatic patients
      with severe organic MV regurgitation and preserved LV function [citation 5, 6].
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite endpoint: cardiovascular mortality, congestive heart failure and hospitalization for nonfatal cardiovascular events
time frame: Min. 5 years
description: The primary outcome is defined as 'time to first event'. It concerns time to first event of the composite endpoint of cardiovascular mortality, congestive heart failure, non-fatal cardiovascular events requiring hospitalization, defined as: stroke/cerebrovascular accident (CVA), atrial fibrillation (permanent or requiring hospitalization) and/or reoperation after elective MV surgery.
measure: Cardiovascular mortality
time frame: Min. 5 years
description: Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
measure: Congestive heart failure
time frame: Min. 5 years
description: Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
measure: Hospitalization for nonfatal cardiovascular events
time frame: Min. 5 years
description: Secondary outcome measures are the separate components of the composite primary endpoint: cardiovascular mortality, congestive heart failure, hospitalization for nonfatal cardiovascular events (stroke/cerebrovascular accident (CVA), AF (permanent or requiring hospitalization) and reoperation after elective MV surgery).
measure: All-cause mortality
time frame: Min. 5 years
description: Secondary outcome measures the incidence of all-cause mortality at a minimum of 5 years.
measure: Costs and effectiveness
time frame: Min. 5 years
description: Secondary outcome measures total direct and indirect costs and cost-effectiveness at a minimum of 5 years.
measure: Health-related quality of life
time frame: Min. 5 years
description: Secondary outcome measures health-related quality of life at a minimum of 5 years.
measure: Echocardiographic parameters
time frame: Min. 5 years
description: Secondary outcome measures echocardiographic parameters at a minimum of 5 years.
measure: CMR parameters
time frame: Min. 5 years.
description: Secondary outcome measures Cardiovascular Magnetic Resonance imaging (CMR) parameters at a minimum of 5 years.
measure: Paroxysmal atrial fibrillation
time frame: Min. 5 years
description: Secondary outcome measures the incidence of paroxysmal atrial fibrillation at a minimum of 5 years.
measure: Exercise test parameters
time frame: Min. 5 years.
description: Secondary outcome measures exercise test parameters at a minimum of 5 years.
measure: BNP
time frame: Min. 5 years
description: Secondary outcome measures brain natriuretic peptide (BNP) plasma levels at a minimum of 5 years.
measure: Myocardial infarction
time frame: Min. 5 years
description: Secondary outcome measures the incidence of myocardial infarction at a minimum of 5 years.
measure: Pacemaker implantation
time frame: Min. 5 years
description: Secondary outcome measures the incidence of pacemaker implantation at a minimum of 5 years.
measure: Transient ischemic attack
time frame: Min. 5 years
description: Secondary outcome measures the incidence of transient ischemic attack (TIA) at a minimum of 5 years.
measure: Pulmonary embolism
time frame: Min. 5 years
description: Secondary outcome measures the incidence of pulmonary embolism at a minimum of 5 years.
measure: Surgery complication rate
time frame: Min. 5 years
description: The complication rate in the mitral valve surgery group (e.g. re-operation for bleeding, pneumonia, residual or recurrent mitral valve regurgitation) will be determined at a minimum of 5 years.
measure: Rate for the need of facilitated surgery
time frame: Min. 5 years
description: Rate for the need of facilitated surgery in the watchful waiting group will be determined at a minimum of 5 years.
arm group label: Early mitral valve repair
arm group type: Active Comparator
description: Early mitral valve repair
arm group label: Watchful waiting
arm group type: Active Comparator
description: Watchful waiting
intervention type: Other
intervention name: Watchful waiting
description: In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.
arm group label: Watchful waiting
intervention type: Procedure
intervention name: Early mitral valve repair
description: Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.
arm group label: Early mitral valve repair
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Steven AJ Chamuleau, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Utrecht (UMC Utrecht)
last name: Jolanda Kluin, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Utrecht (UMC Utrecht)
last name: Robert JM Klautz, Prof. MD PhD
role: Principal Investigator
affiliation: Leiden University Medical Center (LUMC Leiden)
facility: 
facility: 
facility: 
facility: 
country: Netherlands
url: http://dutchamr.nl/
description: Dutch AMR study homepage
citation: Ling LH, Enriquez-Sarano M, Seward JB, Orszulak TA, Schaff HV, Bailey KR, Tajik AJ, Frye RL. Early surgery in patients with mitral regurgitation due to flail leaflets: a long-term outcome study. Circulation. 1997 Sep 16;96(6):1819-25. doi: 10.1161/01.cir.96.6.1819.
PMID: 9323067
citation: Enriquez-Sarano M, Avierinos JF, Messika-Zeitoun D, Detaint D, Capps M, Nkomo V, Scott C, Schaff HV, Tajik AJ. Quantitative determinants of the outcome of asymptomatic mitral regurgitation. N Engl J Med. 2005 Mar 3;352(9):875-83. doi: 10.1056/NEJMoa041451.
PMID: 15745978
citation: Chenot F, Montant P, Vancraeynest D, Pasquet A, Gerber B, Noirhomme PH, El Khoury G, Vanoverschelde JL. Long-term clinical outcome of mitral valve repair in asymptomatic severe mitral regurgitation. Eur J Cardiothorac Surg. 2009 Sep;36(3):539-45. doi: 10.1016/j.ejcts.2009.02.063. Epub 2009 Jul 25.
PMID: 19632855
citation: Rosenhek R, Rader F, Klaar U, Gabriel H, Krejc M, Kalbeck D, Schemper M, Maurer G, Baumgartner H. Outcome of watchful waiting in asymptomatic severe mitral regurgitation. Circulation. 2006 May 9;113(18):2238-44. doi: 10.1161/CIRCULATIONAHA.105.599175. Epub 2006 May 1.
PMID: 16651470
citation: Tietge WJ, de Heer LM, van Hessen MW, Jansen R, Bots ML, van Gilst W, Schalij M, Klautz RJ, Van den Brink RB, Van Herwerden LA, Doevendans PA, Chamuleau SA, Kluin J. Early mitral valve repair versus watchful waiting in patients with severe asymptomatic organic mitral regurgitation; rationale and design of the Dutch AMR trial, a multicenter, randomised trial. Neth Heart J. 2012 Mar;20(3):94-101. doi: 10.1007/s12471-012-0249-y.
PMID: 22354529
citation: Jansen R, Kluin J, Chamuleau SA. Research versus clinical practice in asymptomatic patients with severe organic mitral regurgitation and preserved LV function. J Am Coll Cardiol. 2014 Oct 14;64(15):1639-40. doi: 10.1016/j.jacc.2014.07.964. No abstract available.
PMID: 25301470
responsible party type: Principal Investigator
investigator affiliation: UMC Utrecht
investigator full name: S.A.J. Chamuleau
investigator title: MD, PhD
mesh term: Mitral Valve Insufficiency