<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/NCT03285724</url>
  </required_header>
  <id_info>
    <org_study_id>HMEFS-2000</org_study_id>
    <nct_id>NCT03285724</nct_id>
  </id_info>
  <brief_title>Safety and Performance Study of the Harpoon Mitral Valve Repair System</brief_title>
  <official_title>Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Edwards Lifesciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Edwards Lifesciences</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>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the safety and performance of the Harpoon&#xD;
      Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages&#xD;
      over current surgical interventions including: 1) a small minimally invasive incision, 2) no&#xD;
      sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the&#xD;
      valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length&#xD;
      adjustment and 8) less complicated procedure that is teachable and adoptable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The device is designed to reduce the degree of mitral regurgitation by delivering and&#xD;
      anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating&#xD;
      heart.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Edwards Lifesciences acquired Harpoon Medical in December 2017 and a decision has been made to&#xD;
    close enrollment in the HMEFS-2000 protocol&#xD;
  </why_stopped>
  <start_date type="Actual">May 16, 2017</start_date>
  <completion_date type="Actual">April 20, 2018</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</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>
    <intervention_model_description>Single Group Assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Procedural Success During the First 30 Days</measure>
    <time_frame>Procedure, discharge, and 30 days</time_frame>
    <description>To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from &quot;severe&quot; to less than or equal to &quot;moderate&quot; at the conclusion of the procedure and at 30 days post-procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days</measure>
    <time_frame>Procedure, Discharge and 30 Days</time_frame>
    <description>Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subject's Severity of Mitral Regurgitation Over Time</measure>
    <time_frame>6 Months, 12 Months, and 24 Months</time_frame>
    <description>Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Freedom From Serious Adverse Events Over Time</measure>
    <time_frame>6 Months, 12 Months, and 24 Months</time_frame>
    <description>Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Mitral Valve Regurgitation</condition>
  <condition>Mitral Valve Prolapse</condition>
  <condition>Mitral Valve Insufficiency</condition>
  <arm_group>
    <arm_group_label>Harpoon Medical Transapical device TSD-5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Harpoon Artificial ePTFE Chords</intervention_name>
    <description>The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.</description>
    <arm_group_label>Harpoon Medical Transapical device TSD-5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patient referred for mitral valve surgery&#xD;
&#xD;
          -  Presence of severe MR as read on an echocardiographic study performed within 60 days&#xD;
             prior to procedure.&#xD;
&#xD;
          -  Estimated post-ePTFE cordal implantation coaptation surface is adequate in the&#xD;
             judgment of the operating surgeon and the patient eligibility committee&#xD;
&#xD;
          -  Degenerative mitral valve disease associated with anterior, bileaflet, or posterior&#xD;
             leaflet prolapse&#xD;
&#xD;
          -  Patient is able to sign informed consent and able to return for follow-up and is&#xD;
             capable of participating in all testing associated with this clinical investigation&#xD;
&#xD;
          -  Women of child-bearing potential have a negative pregnancy test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Infective endocarditis&#xD;
&#xD;
          -  History of Mediastinal Radiation&#xD;
&#xD;
          -  Inflammatory (rheumatic) valve disease&#xD;
&#xD;
          -  Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting&#xD;
             (CABG), aortic valve surgery, etc.)&#xD;
&#xD;
          -  Symptomatic coronary artery disease&#xD;
&#xD;
          -  Cardiogenic shock at the time of enrollment&#xD;
&#xD;
          -  ST segment elevation myocardial infarction requiring intervention within 30 days prior&#xD;
             to enrollment&#xD;
&#xD;
          -  Evidence of cirrhosis or hepatic synthetic failure&#xD;
&#xD;
          -  Pregnancy at the time of enrollment (women of child bearing age should have negative&#xD;
             pregnancy within 14 days of surgery)&#xD;
&#xD;
          -  Severe pulmonary hypertension (PA systolic pressure &gt; 70 mmHg)&#xD;
&#xD;
          -  Previous cardiac surgery, or surgery on the left pleural space&#xD;
&#xD;
          -  Left ventricular, atrial or appendage thrombus&#xD;
&#xD;
          -  Severely calcified mitral leaflets&#xD;
&#xD;
          -  Recent stroke (&lt; 6 months) with permanent impairment&#xD;
&#xD;
          -  EuroScore (for mitral valve repair) &gt; 8%&#xD;
&#xD;
          -  Patients with contraindications to Transesophageal echocardiography&#xD;
&#xD;
          -  Severe left or right ventricular dysfunction&#xD;
&#xD;
          -  NYHA Class IV&#xD;
&#xD;
          -  Renal insufficiency CKD stage 3b or worse (GFR &lt; 45 ml/min/1.73 m2)&#xD;
&#xD;
          -  Patient is participating in another clinical study for which follow-up is currently&#xD;
             ongoing. (Co-enrollment in an investigational device or interventional study)&#xD;
&#xD;
          -  Patient with non-cardiac co-morbidities and life expectancy &lt; 1 year&#xD;
&#xD;
          -  Patient has a condition or conditions that, in the opinion of the Investigator,&#xD;
             preclude participation, including willingness to comply with all follow-up procedures&#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>Krzysztof Bartus, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jagiellonian University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jagiellonian University</name>
      <address>
        <city>Krakow</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut of Kardiologii &amp; Transplantology</name>
      <address>
        <city>Warsaw</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>September 23, 2019</results_first_submitted>
  <results_first_submitted_qc>September 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2019</results_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mitral Valve Repair</keyword>
  <keyword>Transapical</keyword>
  <keyword>artificial chordae</keyword>
  <keyword>bi-leaflet prolapse</keyword>
  <keyword>anterior prolapse</keyword>
  <keyword>posterior prolapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
    <mesh_term>Mitral Valve Prolapse</mesh_term>
    <mesh_term>Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <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>October 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03285724/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Harpoon Medical Device</title>
          <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Harpoon Medical Device</title>
          <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Procedural Success During the First 30 Days</title>
        <description>To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from &quot;severe&quot; to less than or equal to &quot;moderate&quot; at the conclusion of the procedure and at 30 days post-procedure.</description>
        <time_frame>Procedure, discharge, and 30 days</time_frame>
        <population>Subject was not implanted with study Device</population>
        <group_list>
          <group group_id="O1">
            <title>Harpoon Medical Device</title>
            <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Procedural Success During the First 30 Days</title>
          <description>To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from &quot;severe&quot; to less than or equal to &quot;moderate&quot; at the conclusion of the procedure and at 30 days post-procedure.</description>
          <population>Subject was not implanted with study Device</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days</title>
        <description>Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.</description>
        <time_frame>Procedure, Discharge and 30 Days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Harpoon Medical Device</title>
            <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days</title>
          <description>Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 Days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Severity of Mitral Regurgitation Over Time</title>
        <description>Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
        <time_frame>6 Months, 12 Months, and 24 Months</time_frame>
        <population>Participant did not receive the Harpoon Medical Device.</population>
        <group_list>
          <group group_id="O1">
            <title>Harpoon Medical Device</title>
            <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Severity of Mitral Regurgitation Over Time</title>
          <description>Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
          <population>Participant did not receive the Harpoon Medical Device.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Freedom From Serious Adverse Events Over Time</title>
        <description>Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
        <time_frame>6 Months, 12 Months, and 24 Months</time_frame>
        <population>Participant did not receive the Harpoon Medical Device.</population>
        <group_list>
          <group group_id="O1">
            <title>Harpoon Medical Device</title>
            <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Freedom From Serious Adverse Events Over Time</title>
          <description>Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded</description>
          <population>Participant did not receive the Harpoon Medical Device.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Events occurring from baseline through end of procedure.</time_frame>
      <desc>Participant did not receive the Harpoon Medical Device.</desc>
      <group_list>
        <group group_id="E1">
          <title>Harpoon Medical Device</title>
          <description>Safety and Performance study of the Harpoon Medical Device in patients with degenerative mitral regurgitation.</description>
        </group>
      </group_list>
      <serious_events>
        <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="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Implantation cord failure, mitral ring damage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>PI must submit publication 60 days prior to its submission for presentation/publication to Sponsor. The Sponsor may, at its sole discretion, (a) approve the publication, (b) reject the publication, or (c) suggest changes to the publication to ensure protection of confidential commercial information in compliance with regulatory requirements. Until the content of any publication is approved by the Sponsor and the PI, the PI shall not disclose such publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart</name_or_title>
      <organization>Edwards Lifesciences, LLC</organization>
      <phone>949-250-2500 ext 0225</phone>
      <email>Andrey_Nersesov@edwards.com</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/NCT03285724
org study id: HMEFS-2000
nct id: NCT03285724
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
The primary objective of this study is to evaluate the safety and performance of the Harpoon
      Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages
      over current surgical interventions including: 1) a small minimally invasive incision, 2) no
      sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the
      valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length
      adjustment and 8) less complicated procedure that is teachable and adoptable.
The device is designed to reduce the degree of mitral regurgitation by delivering and
      anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating
      heart.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects With Procedural Success During the First 30 Days
time frame: Procedure, discharge, and 30 days
description: To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
measure: Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
time frame: Procedure, Discharge and 30 Days
description: Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
measure: Subject's Severity of Mitral Regurgitation Over Time
time frame: 6 Months, 12 Months, and 24 Months
description: Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
measure: Subject's Freedom From Serious Adverse Events Over Time
time frame: 6 Months, 12 Months, and 24 Months
description: Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded
arm group label: Harpoon Medical Transapical device TSD-5
arm group type: Experimental
description: This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.
intervention type: Device
intervention name: Harpoon Artificial ePTFE Chords
description: The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.
arm group label: Harpoon Medical Transapical device TSD-5
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Krzysztof Bartus, MD PhD
role: Principal Investigator
affiliation: Jagiellonian University
facility: 
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
mesh term: Mitral Valve Prolapse
mesh term: Prolapse
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 