<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/NCT04475315</url>
  </required_header>
  <id_info>
    <org_study_id>20200679</org_study_id>
    <nct_id>NCT04475315</nct_id>
  </id_info>
  <brief_title>Ventricular Sling for Heart Failure With Reduced Ejection Fraction</brief_title>
  <official_title>Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to investigate the effect of using this surgical technique in&#xD;
      conjunction with bypass surgery to improve heart function and size, as well as decrease the&#xD;
      possibility of future mitral valve surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Sling is used to draw together the ventricular walls at the base of the papillary&#xD;
      muscles. This technique has previously been used in conjunction with mitral valve surgery,&#xD;
      and has shown significant benefits for the patients.&#xD;
&#xD;
      The reduction in the lateral inter-papillary muscle separation and in the left ventricular&#xD;
      volume provided by this technique is expected to improve ventricular function, limit&#xD;
      progression of ventricular dilation, and avoid progression of MR when performed without&#xD;
      mitral valve surgery in patients with symptomatic ventricular dilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty with recruitment&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 12, 2021</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">December 2027</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>Change in left ventricular function as assessed by LVEF</measure>
    <time_frame>Baseline, up to 5 years</time_frame>
    <description>Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in left ventricular volume</measure>
    <time_frame>Baseline, up to 5 years</time_frame>
    <description>End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality Rate</measure>
    <time_frame>5 years</time_frame>
    <description>Rate of reported mortality rate will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Major Adverse Cardiac Events (MACE)</measure>
    <time_frame>5 years</time_frame>
    <description>MACE is defined as a composite of clinical events comprised of death, stroke, worsening heart failure defined as +1 New York Heart Association (NYHA) class, Congestive Heart Failure (CHF) hospitalization and mitral valve intervention as evaluated by treating physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants at each FMR severity grade</measure>
    <time_frame>Baseline, up to 5 years</time_frame>
    <description>Functional Mitral Regurgitation (FMR) severity is graded on a scale of 1 to 4 with 1 = none, 2 =mild, 3 = moderate and 4 =severe. This outcome will report the percentage of participants with reported none, mild, moderate or severe mitral regurgitation as assessed via echocardiogram by treating physician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in MLHF Questionnaire Score</measure>
    <time_frame>Baseline, up to 5 years</time_frame>
    <description>Minnesota Living with Heart Failure (MLHF) is a 21-item questionnaire with a total score ranging from 0 (indicating heart failure has no affect to life) to 105 (indicating the greatest affect to life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Functional Status as assessed by 6MWT</measure>
    <time_frame>Baseline, up to 5 years</time_frame>
    <description>Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Cause Readmission Rate</measure>
    <time_frame>5 years</time_frame>
    <description>All cause readmission rate will be calculated for any case throughout the duration of study participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Failure Readmission Rate</measure>
    <time_frame>5 years</time_frame>
    <description>Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Mitral Leaflet Tenting</measure>
    <time_frame>5 years</time_frame>
    <description>Mitral Leaflet tenting will be evaluated using echocardiographic imaging.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Heart Failure</condition>
  <condition>Cardiomyopathy, Dilated</condition>
  <arm_group>
    <arm_group_label>Papillary Muscle Sling Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the control group will receive their SOC CABG surgery only, without any additional intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Papillary Muscle Sling</intervention_name>
    <description>The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened.</description>
    <arm_group_label>Papillary Muscle Sling Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG surgery</intervention_name>
    <description>Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery</description>
    <arm_group_label>Controls Group</arm_group_label>
    <arm_group_label>Papillary Muscle Sling Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with symptomatic heart failure with reduced ejection fraction and either ischemic&#xD;
        or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the&#xD;
        ventricular sling procedure is determined by the surgeon and or cardiologist, using some or&#xD;
        all the criteria described below:&#xD;
&#xD;
          -  Left ventricular end diastolic diameter is greater than or equal to 55mm.&#xD;
&#xD;
          -  Ejection fraction ≥20% and ≤40%&#xD;
&#xD;
          -  FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of&#xD;
             echocardiography at the time of the study approval (via a transthoracic or&#xD;
             transesophageal echo).&#xD;
&#xD;
          -  End-systolic Interpapillary muscle distance ≥ 20mm&#xD;
&#xD;
          -  Cardiomyopathy of ischemic or non-ischemic origins.&#xD;
&#xD;
          -  Able to sign informed consent and release of medical information forms, or able to&#xD;
             assign a legal representative who can sign on the patient's behalf.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any evidence of structural (chordal or leaflet) mitral lesions.&#xD;
&#xD;
          -  Planned concomitant intra-operative procedures (except for closure of patent foramen&#xD;
             ovale or atrial septal defect or coronary revascularization)&#xD;
&#xD;
          -  Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial&#xD;
             fibrillation.&#xD;
&#xD;
          -  Persistent atrial fibrillation&#xD;
&#xD;
          -  Prior mitral valve repair&#xD;
&#xD;
          -  Contraindication for cardiopulmonary bypass&#xD;
&#xD;
          -  Clinical signs of cardiogenic shock&#xD;
&#xD;
          -  ST segment elevation myocardial infarction within 14 days prior to inclusion in this&#xD;
             study.&#xD;
&#xD;
          -  Congenital heart disease (except PFO or ASD)&#xD;
&#xD;
          -  Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement&#xD;
             therapy, who are contraindicated for cardiac surgery&#xD;
&#xD;
          -  Recent history of psychiatric disease that is likely to impair compliance with the&#xD;
             study protocol, in the judgement of the investigator&#xD;
&#xD;
          -  Pregnancy&#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_official>
    <last_name>Joseph Lamelas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209.</citation>
    <PMID>24364086</PMID>
  </reference>
  <reference>
    <citation>Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29.</citation>
    <PMID>23545430</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Joseph Lamelas</investigator_full_name>
    <investigator_title>Chief and Program Director of Cardiothoracic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Cardiomyopathies</mesh_term>
    <mesh_term>Cardiomyopathy, Dilated</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/NCT04475315
org study id: 20200679
nct id: NCT04475315
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this research is to investigate the effect of using this surgical technique in
      conjunction with bypass surgery to improve heart function and size, as well as decrease the
      possibility of future mitral valve surgery.
The Sling is used to draw together the ventricular walls at the base of the papillary
      muscles. This technique has previously been used in conjunction with mitral valve surgery,
      and has shown significant benefits for the patients.

      The reduction in the lateral inter-papillary muscle separation and in the left ventricular
      volume provided by this technique is expected to improve ventricular function, limit
      progression of ventricular dilation, and avoid progression of MR when performed without
      mitral valve surgery in patients with symptomatic ventricular dilation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in left ventricular function as assessed by LVEF
time frame: Baseline, up to 5 years
description: Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram
measure: Change in left ventricular volume
time frame: Baseline, up to 5 years
description: End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.
measure: Mortality Rate
time frame: 5 years
description: Rate of reported mortality rate will be evaluated.
measure: Number of Major Adverse Cardiac Events (MACE)
time frame: 5 years
description: MACE is defined as a composite of clinical events comprised of death, stroke, worsening heart failure defined as +1 New York Heart Association (NYHA) class, Congestive Heart Failure (CHF) hospitalization and mitral valve intervention as evaluated by treating physician
measure: Percentage of participants at each FMR severity grade
time frame: Baseline, up to 5 years
description: Functional Mitral Regurgitation (FMR) severity is graded on a scale of 1 to 4 with 1 = none, 2 =mild, 3 = moderate and 4 =severe. This outcome will report the percentage of participants with reported none, mild, moderate or severe mitral regurgitation as assessed via echocardiogram by treating physician.
measure: Change in MLHF Questionnaire Score
time frame: Baseline, up to 5 years
description: Minnesota Living with Heart Failure (MLHF) is a 21-item questionnaire with a total score ranging from 0 (indicating heart failure has no affect to life) to 105 (indicating the greatest affect to life).
measure: Change in Functional Status as assessed by 6MWT
time frame: Baseline, up to 5 years
description: Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT).
measure: All Cause Readmission Rate
time frame: 5 years
description: All cause readmission rate will be calculated for any case throughout the duration of study participation.
measure: Heart Failure Readmission Rate
time frame: 5 years
description: Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.
measure: Incidence of Mitral Leaflet Tenting
time frame: 5 years
description: Mitral Leaflet tenting will be evaluated using echocardiographic imaging.
arm group label: Papillary Muscle Sling Group
arm group type: Experimental
description: Participants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery.
arm group label: Controls Group
arm group type: Active Comparator
description: Participants in the control group will receive their SOC CABG surgery only, without any additional intervention.
intervention type: Device
intervention name: Papillary Muscle Sling
description: The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened.
arm group label: Papillary Muscle Sling Group
intervention type: Procedure
intervention name: CABG surgery
description: Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery
arm group label: Controls Group
arm group label: Papillary Muscle Sling Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Lamelas, MD
role: Principal Investigator
affiliation: University of Miami
country: United States
citation: Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209.
PMID: 24364086
citation: Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29.
PMID: 23545430
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Joseph Lamelas
investigator title: Chief and Program Director of Cardiothoracic Surgery
mesh term: Heart Failure
mesh term: Cardiomyopathies
mesh term: Cardiomyopathy, Dilated
sharing ipd: No