<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/NCT03012178</url>
  </required_header>
  <id_info>
    <org_study_id>967510-2</org_study_id>
    <nct_id>NCT03012178</nct_id>
  </id_info>
  <brief_title>MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery</brief_title>
  <acronym>MRI-MVS</acronym>
  <official_title>Prospective Evaluation of MRI as a Predictor of Outcomes in Patients Undergoing Mitral Valve Surgery: MRI-MVS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Atlantic Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Atlantic Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the&#xD;
      severity of mitral regurgitation is central to determining which patients are appropriate for&#xD;
      correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is&#xD;
      made, patients are considered appropriate for mitral valve surgery in almost all clinical&#xD;
      circumstances. However, there is a significant mortality and morbidity associated with mitral&#xD;
      valve surgery The most common diagnostic tool to assess the severity of MR is&#xD;
      echocardiography. Several studies have shown that echocardiography parameters used to&#xD;
      quantify and qualify MR have high inter-observer and intra-observer variability, calling the&#xD;
      accuracy of these parameters into question. Furthermore, studies have shown that there is a&#xD;
      significant degree of discordance between echocardiography and MRI when assessing MR,&#xD;
      particularly among patients referred for mitral valve surgery. In a recent study,&#xD;
      quantification of mitral regurgitant volume MRI was found to be more accurate than&#xD;
      echocardiography in patients who underwent mitral valve surgery. All 38 patients who&#xD;
      underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA&#xD;
      guidelines based on echocardiographic findings. However, more than 2/3rds of patients who&#xD;
      underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose&#xD;
      this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients&#xD;
      undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and&#xD;
      healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post&#xD;
      surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.&#xD;
      repair according to MR severity by MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mitral regurgitation is a common disease which can lead to heart failure and death if left&#xD;
      untreated. The only known therapy for mitral regurgitation is correction of the mitral valve,&#xD;
      most commonly performed by surgical repair or replacement. According the STS database, there&#xD;
      were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has&#xD;
      been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA&#xD;
      guidelines for the management of mitral valve disease, quantifying the severity of mitral&#xD;
      regurgitation is central to determining which patients are appropriate for correction of&#xD;
      their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made,&#xD;
      patients are considered appropriate for mitral valve surgery in almost all clinical&#xD;
      circumstances. However, there is a significant mortality and morbidity associated with mitral&#xD;
      valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for&#xD;
      replacement. This data does not take into account long-term mortality and morbidity from&#xD;
      re-operation and life-long anti-coagulation as well as changes in quality of life.&#xD;
&#xD;
      The most common diagnostic tool to assess the severity of MR is echocardiography. Several&#xD;
      studies have shown that echocardiography parameters used to quantify and qualify MR have high&#xD;
      inter-observer and intra-observer variability, calling the accuracy of these parameters into&#xD;
      question. Furthermore, studies have shown that there is a significant degree of discordance&#xD;
      between echocardiography and MRI when assessing MR, particularly among patients referred for&#xD;
      mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was&#xD;
      found to be more accurate than echocardiography in patients who underwent mitral valve&#xD;
      surgery. All 38 patients who underwent mitral valve surgery in this study were deemed&#xD;
      appropriate according the ACC/AHA guidelines based on echocardiographic findings. However,&#xD;
      more than 2/3rds of patients who underwent mitral valve surgery in this study did not have&#xD;
      severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the&#xD;
      severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral&#xD;
      valve surgery on quality of life and healthcare costs in the context of MR severity by MRI,&#xD;
      3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the&#xD;
      likelihood of valve replacement vs. repair according to MR severity by MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.</measure>
    <time_frame>2 years</time_frame>
    <description>Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 years</time_frame>
    <description>Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Repair vs Replacement</measure>
    <time_frame>4 months</time_frame>
    <description>Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.</measure>
    <time_frame>0 days</time_frame>
    <description>Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.</measure>
    <time_frame>4 months</time_frame>
    <description>Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Mitral Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Mitral Valve Surgery</arm_group_label>
    <description>Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mitral valve surgery</intervention_name>
    <description>ACC/AHA guideline directed mitral valve repair or replacement</description>
    <arm_group_label>Mitral Valve Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are scheduled to undergo ACC/AHA guideline directed mitral valve surgery for&#xD;
        mitral regurgitation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older.&#xD;
&#xD;
          -  Able to give informed consent.&#xD;
&#xD;
          -  Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within&#xD;
             30 days.&#xD;
&#xD;
          -  Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA&#xD;
             guidelines for the management of valvular heart disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary mitral regurgitation.&#xD;
&#xD;
          -  Have a device which is not compatible with MRI&#xD;
&#xD;
          -  Claustrophobia preventing MRI.&#xD;
&#xD;
          -  Concomitant CABG, other valve surgery, or other cardiac surgery.&#xD;
&#xD;
          -  Atrial fibrillation or other substantial arrhythmia that would substantially degrade&#xD;
             MRI image acquisition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Seth Uretsky, MD</last_name>
    <phone>9739715597</phone>
    <email>seth.uretsky@atlantichealth.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Susan Miller, RN</last_name>
    <phone>9739715597</phone>
    <email>susan.miller@atlantichealth.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seth Uretsky, MD</last_name>
      <phone>973-971-5597</phone>
      <email>seth.uretsky@atlantichealth.org</email>
    </contact>
    <contact_backup>
      <last_name>Susan Miller, RN</last_name>
      <phone>9739715597</phone>
      <email>susan.miller@atlantichealth.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mitral Regurgitation</keyword>
  <keyword>Mitral valve Surgery</keyword>
  <keyword>MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012178
org study id: 967510-2
nct id: NCT03012178
lead sponsor: 
has dmc: No
Based on the ACC/AHA guidelines for the management of mitral valve disease, quantifying the
      severity of mitral regurgitation is central to determining which patients are appropriate for
      correction of their mitral valve by surgery. Specifically, once the diagnosis of severe MR is
      made, patients are considered appropriate for mitral valve surgery in almost all clinical
      circumstances. However, there is a significant mortality and morbidity associated with mitral
      valve surgery The most common diagnostic tool to assess the severity of MR is
      echocardiography. Several studies have shown that echocardiography parameters used to
      quantify and qualify MR have high inter-observer and intra-observer variability, calling the
      accuracy of these parameters into question. Furthermore, studies have shown that there is a
      significant degree of discordance between echocardiography and MRI when assessing MR,
      particularly among patients referred for mitral valve surgery. In a recent study,
      quantification of mitral regurgitant volume MRI was found to be more accurate than
      echocardiography in patients who underwent mitral valve surgery. All 38 patients who
      underwent mitral valve surgery in this study were deemed appropriate according the ACC/AHA
      guidelines based on echocardiographic findings. However, more than 2/3rds of patients who
      underwent mitral valve surgery in this study did not have severe MR by MRI. Thus, we propose
      this prospective multicenter trial to assess: 1) the severity of MR by MRI in patients
      undergoing mitral valve surgery. 2) the impact of mitral valve surgery on quality of life and
      healthcare costs in the context of MR severity by MRI, 3) assess patient outcomes post
      surgery in the context of MR severity by MRI and 4) the likelihood of valve replacement vs.
      repair according to MR severity by MRI.
Mitral regurgitation is a common disease which can lead to heart failure and death if left
      untreated. The only known therapy for mitral regurgitation is correction of the mitral valve,
      most commonly performed by surgical repair or replacement. According the STS database, there
      were 15,748 lone mitral valve surgeries in 2014. The number of mitral valve surgeries has
      been increasing with a 23% increase between the years 2010 and 2014. Based on the ACC/AHA
      guidelines for the management of mitral valve disease, quantifying the severity of mitral
      regurgitation is central to determining which patients are appropriate for correction of
      their mitral valve by surgery. Specifically, once the diagnosis of severe MR is made,
      patients are considered appropriate for mitral valve surgery in almost all clinical
      circumstances. However, there is a significant mortality and morbidity associated with mitral
      valve surgery. In the STS database, 30 day mortality was ~2% for repair and ~5% for
      replacement. This data does not take into account long-term mortality and morbidity from
      re-operation and life-long anti-coagulation as well as changes in quality of life.

      The most common diagnostic tool to assess the severity of MR is echocardiography. Several
      studies have shown that echocardiography parameters used to quantify and qualify MR have high
      inter-observer and intra-observer variability, calling the accuracy of these parameters into
      question. Furthermore, studies have shown that there is a significant degree of discordance
      between echocardiography and MRI when assessing MR, particularly among patients referred for
      mitral valve surgery. In a recent study, quantification of mitral regurgitant volume MRI was
      found to be more accurate than echocardiography in patients who underwent mitral valve
      surgery. All 38 patients who underwent mitral valve surgery in this study were deemed
      appropriate according the ACC/AHA guidelines based on echocardiographic findings. However,
      more than 2/3rds of patients who underwent mitral valve surgery in this study did not have
      severe MR by MRI. Thus, we propose this prospective multicenter trial to assess: 1) the
      severity of MR by MRI in patients undergoing mitral valve surgery. 2) the impact of mitral
      valve surgery on quality of life and healthcare costs in the context of MR severity by MRI,
      3) assess patient outcomes post surgery in the context of MR severity by MRI and 4) the
      likelihood of valve replacement vs. repair according to MR severity by MRI.
observational model: Cohort
time perspective: Prospective
measure: Operative and peri-operative outcomes according to the mitral regurgitation severity quantified by MRI.
time frame: 2 years
description: Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
measure: Quality of life
time frame: 2 years
description: Operative and peri-operative outcomes (mortality, morbidity, hospitalizations, reoperation, bleeding, and CVA) in the context of mitral regurgitation severity quantified by MRI.
measure: Repair vs Replacement
time frame: 4 months
description: Assess if the likelihood of mitral valve repair vs. replacement is associated with mitral regurgitant severity as quantified by MRI.
measure: Severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery.
time frame: 0 days
description: Cross sectional data regarding severity of mitral regurgitation as quantified MRI in subjects who are undergoing guideline directed mitral valve surgery
measure: Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
time frame: 4 months
description: Correlation of pre-surgical regurgitant volume as quantified by MRI with post-surgical change in LV EDV.
arm group label: Mitral Valve Surgery
description: Patients undergoing ACC/AHA guideline directed mitral valve surgery for mitral insufficiency.
intervention type: Procedure
intervention name: Mitral valve surgery
description: ACC/AHA guideline directed mitral valve repair or replacement
arm group label: Mitral Valve Surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Seth Uretsky, MD
phone: 9739715597
email: seth.uretsky@atlantichealth.org
last name: Susan Miller, RN
phone: 9739715597
email: susan.miller@atlantichealth.org
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No