<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/NCT03015194</url>
  </required_header>
  <id_info>
    <org_study_id>999917032</org_study_id>
    <secondary_id>17-H-N032</secondary_id>
    <nct_id>NCT03015194</nct_id>
  </id_info>
  <brief_title>NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation</brief_title>
  <official_title>NHLBI DIR LAMPOON Study: Intentional Laceration of the Anterior Mitral Leaflet to Prevent Left Ventricular Outflow Tract Obstruction During Transcatheter Mitral Valve Implantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral&#xD;
      valve heart problems. But the usual TMVR techniques might cause an obstruction for some&#xD;
      people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants&#xD;
      in this study will be among the first in the world to have this technique done.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To test the safety and effectiveness of the LAMPOON technique in TMVR.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Adults ages 21 and over who are recommended to have TMVR with LAMPOON&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with medical history and exam and by review of medical records.&#xD;
&#xD;
      Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the&#xD;
      procedure.&#xD;
&#xD;
      Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for&#xD;
      the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of&#xD;
      the way before inserting the artificial mitral valve.&#xD;
&#xD;
      Participants will recover in an inpatient recovery unit.&#xD;
&#xD;
      They will repeat the previous tests before leaving the hospital, 1 month later, 6 months&#xD;
      later and 1 year later. They will have yearly follow-up phone calls for about 5 years.&#xD;
&#xD;
      In the event of a participant's death, researchers will ask for an autopsy and to analyze the&#xD;
      heart. Permission for this is not required as part of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when&#xD;
      no surgical options exist. In as many as half of patients, TMVR can cause life-threatening&#xD;
      blockage of the left ventricle by displacing the existing mitral valve leaflet. For these&#xD;
      patients the only options appear to avoid TMVR or in some to cause a focused heart attack and&#xD;
      to wait 6 weeks. The investigators have developed and tested a technique to split the&#xD;
      existing mitral valve leaflet and enable TMVR in patients who have no other options. The&#xD;
      procedure is called intentional laceration of the anterior mitral leaflet to prevent left&#xD;
      ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices&#xD;
      commercially available, there has been short-term success with implanted transcatheter aortic&#xD;
      valve devices in the mitral position for TMVR.&#xD;
&#xD;
      The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options&#xD;
      to treat their mitral valve failure, using heart valve devices designed to implant in the&#xD;
      aortic valve position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">April 13, 2023</completion_date>
  <primary_completion_date type="Actual">July 26, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With &quot;Acceptable&quot; Technical Success of the LAMPOON Procedure</measure>
    <time_frame>Exit from the Cardiac Catheterization Laboratory</time_frame>
    <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 50 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With &quot;Optimal&quot; Technical Success of the LAMPOON Procedure</measure>
    <time_frame>Exit from the Cardiac Catheterization Laboratory</time_frame>
    <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 30 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Mitral Valve Failure</condition>
  <arm_group>
    <arm_group_label>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Edwards SAPIEN 3 transcatheter heart valve</intervention_name>
    <description>Used to relieve aortic stenosis in patients with symptomatic heart disease&#xD;
In this study it is not used for aortic stenosis-----the device is used in the mitral valve position.</description>
    <arm_group_label>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ASHI INTECC Astato XS 20</intervention_name>
    <description>The Astato 0.014&quot; guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step.</description>
    <arm_group_label>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          -  Adults age greater than or equal to 21 years&#xD;
&#xD;
          -  Severe symptomatic native mitral valve failure after mitral annuloplasty repair or&#xD;
             related to mitral annular calcification.&#xD;
&#xD;
          -  Unacceptably high or prohibitive risk for surgical mitral valve replacement and&#xD;
             indicated for transcatheter mitral valve replacement (TMVR) as determined by the&#xD;
             multidisciplinary institutional heart team, including at least one cardiovascular&#xD;
             surgeon who has examined the patient.&#xD;
&#xD;
          -  High or prohibitive risk of LVOT obstruction (predicted neo-LVOT less than 200 mm2) or&#xD;
             transcatheter heart valve dysfunction from long/redundant anterior mitral valve&#xD;
             leaflet, as determined by the multidisciplinary institutional heart team.&#xD;
&#xD;
          -  Anatomic eligibility for LAMPOON based on core lab assessment of the baseline CT and&#xD;
             echocardiogram.&#xD;
&#xD;
          -  Concordance of the study selection team&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Subjects unable to consent to participate, unless the subject has a legally authorized&#xD;
             representative&#xD;
&#xD;
          -  Subjects unwilling to participate or unwilling to return for study follow-up&#xD;
             activities.&#xD;
&#xD;
          -  Predicted neo-LVOT created by the Sapien-3 skirt, after LAMPOON, less than 150 mm2&#xD;
&#xD;
          -  TAVR within 6 weeks&#xD;
&#xD;
          -  Intended concurrent structural heart procedure, such as aortic or tricuspid valve&#xD;
             implantation&#xD;
&#xD;
          -  Pregnancy or intent to become pregnant prior to completion of all protocol follow-up&#xD;
             procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert J Lederman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart, Lung, and Blood Institute (NHLBI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medstar Washington Hospital Center, Cardiovascular Research Program</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INOVA Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carilion Medical Center</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Division of Cardiology</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <results_first_submitted>March 25, 2021</results_first_submitted>
  <results_first_submitted_qc>March 30, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2021</results_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LVOT (left ventricular outflow tract, obstruction)</keyword>
  <keyword>Transcatheter Mitral Valve Implantation</keyword>
  <keyword>Transcatheter Heart Valve</keyword>
  <keyword>Mitral Valve Regurgitation</keyword>
  <keyword>Mitral Valve Stenosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ventricular Outflow Obstruction, Left</mesh_term>
    <mesh_term>Lacerations</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03015194/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Protocol enrolled 32 participants, however 2 participants had screen failed.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</title>
          <description>The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</title>
          <description>The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" lower_limit="47" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With &quot;Acceptable&quot; Technical Success of the LAMPOON Procedure</title>
        <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 50 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
        <time_frame>Exit from the Cardiac Catheterization Laboratory</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</title>
            <description>The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE)or intracardiac echocardiography.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &quot;Acceptable&quot; Technical Success of the LAMPOON Procedure</title>
          <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 50 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Successful LAMPOON traversal and laceration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LVOT gradient &lt;50 mm Hg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Procedure survival</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Successful access, delivery, and retrieval of LAMPOON device system</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Successful deployment and correct positioning of the first intended device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freedom from emergency surgery or reintervention related to the device or access procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With &quot;Optimal&quot; Technical Success of the LAMPOON Procedure</title>
        <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 30 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
        <time_frame>Exit from the Cardiac Catheterization Laboratory</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</title>
            <description>The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &quot;Optimal&quot; Technical Success of the LAMPOON Procedure</title>
          <description>Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an &quot;acceptable technical success&quot; met the following criteria:&#xD;
Successful LAMPOON traversal and laceration; and&#xD;
Peak LVOT gradient &lt; 30 mm Hg; and&#xD;
Absence of procedural mortality; and&#xD;
Successful access, delivery, and retrieval of the LAMPOON device system; and&#xD;
Successful deployment and correct positioning of the first intended device; and&#xD;
Freedom from emergency surgery or reintervention related to the device or access procedure.&#xD;
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Successful LAMPOON traversal and laceration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LVOT gradient &lt;30 mm Hg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Procedure survival</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Successful access, delivery, and retrieval of LAMPOON device system</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Successful deployment and correct positioning of the first intended device</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Freedom from emergency surgery or reintervention related to the device or access procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event recording will start on Day (0) until 30-day follow up, after this only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated device effects (UADE) and unanticipated problems (UP) will be reported to the Sponsor for 1 year.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option</title>
          <description>The intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) is a one-time procedure on Day 0 with three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemolysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular Block complete</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Perivalvular leak</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders other-LVOT obstruction post TMVR.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other -increased mitral valve gradient, TMVR thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-left apical pseudoaneurism.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-increased LVOT gradient post TMVR</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-elevated mitral valve gradient ; possible TMVR thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-perivalvular leak post TMVR</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-perivalvular pseudoaneurysm.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-mitral valve thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>tenting of anterior leaflet of mitral valve causing myocardial dysfunction and severe hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-severe perivalvular leak immediately post TMVR</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders-other-right ventricular apex pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>chest pain-cardiac</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>endocarditis infective</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" events="16" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Esophageal varices hemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gastric hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gastrointestional disorders -other-Toxic Megacolon</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gastrointestional disorders -other-cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions-other-AV fistual bleed.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>General disorders and administration site conditions-other-AV fistual thrombosed.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title vocab="Death">Multi-organ failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteremia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bronchial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>endocarditis infective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Infections and infestations-other-C. Difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Infections and infestations-other-septic emboli</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arterial injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>fall</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications-other-digoxin toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications-other-Coumadin toxicity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injury, poisoning, and procedureal complications-other-opioid toxicity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injury, poisoning and procedural complications-other-subtherapeutic INR-coumadin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>wound complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations other-guidewire fracture and separation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-TMVR embolized</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-TMVR dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations-other-explant of TMVR Sapien -3 due to malpositioning, MAC, and LV calcification</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder-other-generalized pain with impending death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Intracranial hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adult Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory , thoracic and mediastinal disorders-other-pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory , thoracic and mediastinal disorders-other-pneumonia with sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders-other-COPD exacerbation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders-other-excessive secretions while intubated.</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and Medical Procedures-others-alcohol septal ablation to treat LVOT obstruction</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vascular disorder-other-thrombolic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vascular disorders-other-hypotensive shock post cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>vascular disorders-other-thrombotic event</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>CTCAE (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood and Lymphatic systems disorder, other-Elevated WBCs</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemolysis</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="20" subjects_affected="16" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders other-LVOT obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac disorders other-TMVR perivalvular link</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" events="10" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>conduction disorder</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Heart failure</sub_title>
                <counts group_id="E1" events="36" subjects_affected="24" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>dysphagia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lower gastrointestional hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Upper gastrointestional hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Edema Limbs</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>General disorders and administration sites, other-AV fistual bleed</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bladder Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Urinary tract infections</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac troponin I increase</sub_title>
                <counts group_id="E1" events="30" subjects_affected="27" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Haptoglobin decrease</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>INR increased</sub_title>
                <counts group_id="E1" events="17" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-albumin low</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-decreased INR</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations, other-Calcium decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-sodium low</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-low magnesium</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-potassium high</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Investigations other-potassium low</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Platelet Count Decrease</sub_title>
                <counts group_id="E1" events="34" subjects_affected="28" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hematuria</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>urinary retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>pleural effusion</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pulmonary edema</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders, other-pulmonary nodule</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediatinal disorders other-Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediatinal disorders other-Tachypnea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulceration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arterial thromboembolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hematoma</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>thromboembolic event</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>vascular disorders other-bruise</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Robert Lederman, M.D. Principal Investigator, NIH, NHLBI</name_or_title>
      <organization>National Heart Lung and Blood Institute (NHLBI)</organization>
      <phone>301.402.6769</phone>
      <email>ledermar@nhlbi.nih.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03015194
org study id: 999917032
secondary id: 17-H-N032
nct id: NCT03015194
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
Background:

      Transcatheter mitral valve replacement (TMVR) is recommended for some people with mitral
      valve heart problems. But the usual TMVR techniques might cause an obstruction for some
      people. A new technique is called LAMPOON. It may have less risk of obstruction. Participants
      in this study will be among the first in the world to have this technique done.

      Objectives:

      To test the safety and effectiveness of the LAMPOON technique in TMVR.

      Eligibility:

      Adults ages 21 and over who are recommended to have TMVR with LAMPOON

      Design:

      Participants will be screened with medical history and exam and by review of medical records.

      Participants will have blood tests, an ECG, a heart CT scan, and an echocardiogram before the
      procedure.

      Participants will have TMVR with LAMPOON. They will have anesthesia or moderate sedation for
      the procedure. Doctors will use a wire to split the diseased mitral valve and move it out of
      the way before inserting the artificial mitral valve.

      Participants will recover in an inpatient recovery unit.

      They will repeat the previous tests before leaving the hospital, 1 month later, 6 months
      later and 1 year later. They will have yearly follow-up phone calls for about 5 years.

      In the event of a participant's death, researchers will ask for an autopsy and to analyze the
      heart. Permission for this is not required as part of the study.
Transcatheter mitral valve replacement (TMVR) is an option to treat mitral valve failure when
      no surgical options exist. In as many as half of patients, TMVR can cause life-threatening
      blockage of the left ventricle by displacing the existing mitral valve leaflet. For these
      patients the only options appear to avoid TMVR or in some to cause a focused heart attack and
      to wait 6 weeks. The investigators have developed and tested a technique to split the
      existing mitral valve leaflet and enable TMVR in patients who have no other options. The
      procedure is called intentional laceration of the anterior mitral leaflet to prevent left
      ventricular outflow tract obstruction (LAMPOON). Although there are no dedicated TMVR devices
      commercially available, there has been short-term success with implanted transcatheter aortic
      valve devices in the mitral position for TMVR.

      The purpose of this study is to perform LAMPOON and TMVR in patients who have no good options
      to treat their mitral valve failure, using heart valve devices designed to implant in the
      aortic valve position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With "Acceptable" Technical Success of the LAMPOON Procedure
time frame: Exit from the Cardiac Catheterization Laboratory
description: Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:
Successful LAMPOON traversal and laceration; and
Peak LVOT gradient < 50 mm Hg; and
Absence of procedural mortality; and
Successful access, delivery, and retrieval of the LAMPOON device system; and
Successful deployment and correct positioning of the first intended device; and
Freedom from emergency surgery or reintervention related to the device or access procedure.
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
measure: Number of Participants With "Optimal" Technical Success of the LAMPOON Procedure
time frame: Exit from the Cardiac Catheterization Laboratory
description: Participants post intentional laceration of the anterior mitral leaflet to prevent left ventricular outflow tract obstruction (LAMPOON) procedure that were defined as an "acceptable technical success" met the following criteria:
Successful LAMPOON traversal and laceration; and
Peak LVOT gradient < 30 mm Hg; and
Absence of procedural mortality; and
Successful access, delivery, and retrieval of the LAMPOON device system; and
Successful deployment and correct positioning of the first intended device; and
Freedom from emergency surgery or reintervention related to the device or access procedure.
The first two factors are modifications of the MVARC (mitral valve academic research consortium) consensus endpoint, specific for LAMPOON procedure.
arm group label: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
arm group type: Experimental
description: The LAMPOON procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TMVR. These are all guided by fluoroscopy combined with transesophageal echocardiogram (TEE) or intracardiac echocardiography.
intervention type: Device
intervention name: Edwards SAPIEN 3 transcatheter heart valve
description: Used to relieve aortic stenosis in patients with symptomatic heart disease
In this study it is not used for aortic stenosis-----the device is used in the mitral valve position.
arm group label: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
intervention type: Device
intervention name: ASHI INTECC Astato XS 20
description: The Astato 0.014" guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step.
arm group label: Laceration of Anterior Mitral Leaflet in Mitral Valve Failure Participants With no Surgical Option
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Robert J Lederman, M.D.
role: Principal Investigator
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Ventricular Outflow Obstruction, Left
mesh term: Lacerations
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 