<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/NCT01678144</url>
  </required_header>
  <id_info>
    <org_study_id>2010-040</org_study_id>
    <nct_id>NCT01678144</nct_id>
  </id_info>
  <brief_title>Study on Safety and Performance of Medtentia Mitral Valve Repair System in Surgical Repair of Mitral Regurgitation</brief_title>
  <official_title>Evaluation of the Safety and Performance of the Medtentia Mitral Valve Repair System When Used in Adults Undergoing Mitral Valve Repair Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtentia International Ltd Oy</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtentia International Ltd Oy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the trial is to demonstrate the safety and performance of the Medtentia&#xD;
      Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to&#xD;
      demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the safety and performance of the MAR in patients&#xD;
      with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve&#xD;
      annuloplasty concomitantly with any of the following, either individually or in combination:&#xD;
&#xD;
        -  Tricuspid valve repair&#xD;
&#xD;
        -  Coronary artery bypass grafting (CABG)&#xD;
&#xD;
        -  Valve resection and chordae repair&#xD;
&#xD;
        -  Correction of atrial septal defect&#xD;
&#xD;
        -  Correction of patent foramen ovale&#xD;
&#xD;
        -  Ablation therapy for atrial defibrillation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic decision by Sponsor&#xD;
  </why_stopped>
  <start_date type="Actual">June 30, 2011</start_date>
  <completion_date type="Actual">April 22, 2016</completion_date>
  <primary_completion_date type="Actual">July 30, 2014</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>Prospective, multi-national, multi-center, open-label, single-arm</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.</measure>
    <time_frame>Time from surgery through hospital discharge, up to 7 days.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).</measure>
    <time_frame>Time from baseline through V03 (3 months)</time_frame>
    <description>Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.</measure>
    <time_frame>30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery</time_frame>
    <description>Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).</measure>
    <time_frame>From surgery to end of study (2 years)</time_frame>
    <description>MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).</measure>
    <time_frame>From surgery to end of study (2 years).</time_frame>
    <description>All the adverse events reported were non-device related.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).</measure>
    <time_frame>From surgery to end of study (2 years).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).</measure>
    <time_frame>From surgery to end of study (2 years).</time_frame>
    <description>The occurrence, frequency and nature of abnormalities in any of the following:&#xD;
physical examination&#xD;
vital signs&#xD;
electrocardiography (ECG)&#xD;
echocardiography (ECHO)&#xD;
Laboratory tests&#xD;
Chest X-rays (taken only when clinically indicated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.</measure>
    <time_frame>Day of surgery visit (V01).</time_frame>
    <description>Success will be defined as no or only residual mitral regurgitation (MR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).</measure>
    <time_frame>V06 (24 months)</time_frame>
    <description>Measurement analysis at 24 months after successful MAR implantation.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.</measure>
    <time_frame>From screening to end of study (up to 2 years)</time_frame>
    <description>Change from screening at each follow-up visit in the following MR parameters, as measured using TTE:&#xD;
Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)&#xD;
Coaptation height</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.</measure>
    <time_frame>Day of surgery visit (V01)</time_frame>
    <description>Duration of the following key stages of the annuloplasty procedure:&#xD;
MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness)&#xD;
MAR rotation time&#xD;
Suturing time (from start of annulus suturing until last knot)&#xD;
Aortic clamp time&#xD;
Cardiac arrest time</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.</measure>
    <time_frame>At screening and at each follow-up visit (except for discharge visit, up to 2 years).</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.</measure>
    <time_frame>Day of surgery visit (V01)</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Mitral Regurgitation</condition>
  <condition>Mitral Insufficiency</condition>
  <arm_group>
    <arm_group_label>Medtentia Annuloplasty Ring (MAR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</intervention_name>
    <arm_group_label>Medtentia Annuloplasty Ring (MAR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Eligible patients must meet all the following inclusion criteria:&#xD;
&#xD;
          1. Signed Informed Consent Form.&#xD;
&#xD;
          2. Male or female aged ≥18 to ≤ 85 years on the day of screening. Females of childbearing&#xD;
             potential (not surgically sterilized or more than one year post-menopausal) must have&#xD;
             a negative pregnancy test (serum beta-human chorionic gonadotropin (beta-hCG) or&#xD;
             urine) within 24 hours prior to mitral valve surgery.&#xD;
&#xD;
          3. Patient must meet one of the following indications for mitral repair surgery according&#xD;
             to the European Society of Cardiology (ESC) and the American Heart Association (AHA)&#xD;
             guidelines, and must have consented to have such surgery before undergoing the&#xD;
             informed consent process for this study.&#xD;
&#xD;
               -  Symptomatic patient with chronic severe primary mitral regurgitation (MR), left&#xD;
                  ventricle ejection fraction (LVEF) &gt; 30% and left ventricle end systolic diameter&#xD;
                  (LVESD) &lt; 55 mm or&#xD;
&#xD;
               -  Asymptomatic patient with chronic severe primary MR who either:&#xD;
&#xD;
                    -  Has LV dysfunction (LVEF ≤ 60 % and/or LVESD ≥ 40 mm or&#xD;
&#xD;
                    -  Has a preserved LV function (LVEF&gt; 60% and LVESD &lt; 40 mm) together with a&#xD;
                       likelihood of a successful and durable repair of &gt; 95 % and an expected&#xD;
                       mortality rate of &lt; 1% or&#xD;
&#xD;
                    -  Has a flail leaflet and LVESD ≥ 40 mm together with a high likelihood of&#xD;
                       durable repair and a low surgical risk or&#xD;
&#xD;
                    -  Has a new onset of atrial fibrillation or pulmonary hypertension (systolic&#xD;
                       pulmonary pressure &gt; 50 mm Hg at rest) or&#xD;
&#xD;
               -  Asymptomatic patient with chronic moderate or severe primary MR who is to undergo&#xD;
                  cardiac surgery for another indication when the mitral valve (MV) repair can be&#xD;
                  performed concomitantly&#xD;
&#xD;
               -  Patient with chronic severe or moderate secondary MR and an LVEF &gt; 30 % who is&#xD;
                  undergoing CABG concomitantly&#xD;
&#xD;
          4. Patient must have a life expectancy of more than 24 months at the time of screening,&#xD;
             assuming they undergo mitral valve annuloplasty.&#xD;
&#xD;
          5. Patient must have a mitral valve diameter corresponding to MAR size 26 - 40 and&#xD;
             leaflet thickness (smallest helix height - largest helix height) for which an&#xD;
             appropriate MAR ring is available.&#xD;
&#xD;
          6. Patient must be able and willing to attend all scheduled visits and comply with all&#xD;
             study procedures.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Eligible patients must not meet any of the following exclusion criteria:&#xD;
&#xD;
          1. Have had previous cardiac surgery, including but not limited to any of the following:&#xD;
             minimally invasive surgery, mitral valve surgery or valvuloplasty, implantation of a&#xD;
             prosthetic heart valve or cardiac defibrillator.&#xD;
&#xD;
          2. Have ejection fraction below 30%.&#xD;
&#xD;
          3. Plan to have any concomitant cardiac surgery or procedure other than CABG, tricuspid&#xD;
             valve repair, correction of atrial septal defect, closure of auricular appendage,&#xD;
             correction of patent foramen ovale and/or ablation therapy for correction of atrial&#xD;
             fibrillation performed with the mitral valve repair, which may also include leaflet&#xD;
             resection and chordae replacement.&#xD;
&#xD;
          4. Have any structural hindrance or heart abnormality that would make use of the MAR&#xD;
             technically infeasible, such as a mitral valve of an unusual size or leaflet thickness&#xD;
             for which a suitable MAR is not available, or an obstruction or other abnormality that&#xD;
             blocks positioning of the MAR. (Final determination to be made during surgery).&#xD;
&#xD;
          5. Show evidence of having had an acute myocardial infarction (MI) within the 30 days&#xD;
             preceding the mitral valve repair surgery.&#xD;
&#xD;
          6. Have a history of stroke within the preceding 12 months or have had any stroke that is&#xD;
             not completely clinically resolved and/or significant carotid artery disease (subjects&#xD;
             with carotid stenosis ≥50% and/or ulceration).&#xD;
&#xD;
          7. Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy.&#xD;
&#xD;
          8. Have restricted mobility of the mitral apparatus that results in a valvular area less&#xD;
             than 3.0 cm2.&#xD;
&#xD;
          9. Be in need of annular decalcification.&#xD;
&#xD;
         10. Have any comorbidities or conditions that would be a contraindication to open heart&#xD;
             surgery or that would place the patient at an unacceptable surgical risk, such as:&#xD;
             severe chronic obstructive pulmonary disease (COPD); hepatic failure;&#xD;
             immunosuppressive abnormalities or other immunological deficiencies including being&#xD;
             immunocompromised or having an autoimmune disease; chronic renal failure requiring&#xD;
             dialysis; hematological abnormalities including a history of bleeding diathesis or&#xD;
             coagulopathy; being unable to follow the locally recommended anticoagulant regimen; an&#xD;
             intolerance or hypersensitivity to anesthetics; cancer that requires further&#xD;
             radiation, chemotherapy or surgical treatment.&#xD;
&#xD;
         11. Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler.&#xD;
&#xD;
         12. Have any recent psychiatric disorder, including drug or alcohol abuse, that in the&#xD;
             Investigator's opinion could impair the patient's compliance with study procedures.&#xD;
&#xD;
         13. Be currently or have in the preceding 30 days participated in any other study&#xD;
             involving an investigational drug or device.&#xD;
&#xD;
         14. Be an employee of the investigational site directly affiliated with this study, the&#xD;
             sponsor or the clinical research organization or have an immediate family member who&#xD;
             is.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kalervo Werkkala, M.D., Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Helsinki University Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Helsinki University Hospital, Cardiovascular and Thorax Surgery Clinic</name>
      <address>
        <city>Helsinki</city>
        <zip>00029</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <link>
    <url>https://medtentia.com</url>
    <description>Medtentia Company Webpage</description>
  </link>
  <reference>
    <citation>Konerding MA, Simpanen J, Ihlberg L, Aittomaki J, Werkkala K, Delventhal V, Ackermann M. Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model. J Cardiothorac Surg. 2013 Apr 8;8:70. doi: 10.1186/1749-8090-8-70.</citation>
    <PMID>23566678</PMID>
  </reference>
  <reference>
    <citation>Jensen H, Simpanen J, Smerup M, Bjerre M, Bramsen M, Werkkala K, Vainikka T, Hasenkam JM, Wierup P. Medtentia double helix mitral annuloplasty system evaluated in a porcine experimental model. Innovations (Phila). 2010 Mar;5(2):114-7. doi: 10.1097/IMI.0b013e3181d84316.</citation>
    <PMID>22437358</PMID>
  </reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>March 4, 2019</results_first_submitted>
  <results_first_submitted_qc>June 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2019</results_first_posted>
  <last_update_submitted>June 27, 2019</last_update_submitted>
  <last_update_submitted_qc>June 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mitral valve</keyword>
  <keyword>mitral surgery</keyword>
  <keyword>mitral repair</keyword>
  <keyword>mitral annuloplasty</keyword>
  <keyword>mitral valve surgery</keyword>
  <keyword>mitral valve repair</keyword>
  <keyword>mitral valve annuloplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitral Valve Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All patients were enrolled at Helsinki University Central Hospital from June 2011 to April 2014.&#xD;
During Stage 1 (2011-2012) and Stage 2 (2013-2016) MAR was implanted for 12 patients.&#xD;
11 of 24 consented patients did not receive MAR due to non-anatomical fit (majority in Stage 1); for 1 patient MAR was replaced before the operation was completed.</recruitment_details>
      <pre_assignment_details>Patients qualifying for mitral valve repair surgery according to guidelines from the European Society of Cardiology (ESC) and the American Heart Association (AHA) and meeting pre-operative selection criteria.&#xD;
Successful implantation rate improved significantly during Stage 2 after sizing adjustment of the implant (Regular and Expanded).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Medtentia Annuloplasty Ring (MAR)</title>
          <description>All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Stage 1: MAR Classic</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Stage 2: MAR Regular and MAR Expanded</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </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>
      <population>Baseline data are provided for patients enrolled in the Stage 1 and Stage 2.</population>
      <group_list>
        <group group_id="B1">
          <title>Medtentia Annuloplasty Ring (MAR)</title>
          <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)&#xD;
Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</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="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.5" spread="8.3"/>
                  </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="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </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>Finland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>New York Heart Association (NYHA) Functional Capacity</title>
          <description>Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Class I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class III</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class IV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left Ventricular Inner Dimension Systole</title>
          <description>The dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole by trans-thoracic echocardiography.</description>
          <population>Assessment not available for one patient.</population>
          <units>millimeters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" lower_limit="42" upper_limit="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mitral valve regurgitation</title>
          <description>Mitral regurgitation according to American College of Cardiology/ American Heart Association (ACC/AHA) classification determined by echocardiography: Class I - trivial (&lt;0.2 cm2 effective regurgitant orifice (ERO)), Class II - mild (0.2-0.29 cm2 ERO), Class III - moderate (0.3-0.39 cm2 ERO), Class IV - severe (≥0.4 cm2 ERO).</description>
          <population>Assessment not available for one patient.</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Class I</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class II</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class III</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Class IV</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking status</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="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Current smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Non-smoker/ Former smoker</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mitral valve leaflet coaptation height</title>
          <description>Mitral valve leaflet coaptation height assessment by trans-thoracic echocardiography.</description>
          <population>Assessment not available for one patient.</population>
          <units>millimeters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14" lower_limit="9.8" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Left Ventricular Inner Dimension Diastole</title>
          <description>The dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-diastole by trans-thoracic echocardiography.</description>
          <population>Assessment not available for one patient.</population>
          <units>millimeters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" lower_limit="54" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.</title>
        <time_frame>Time from surgery through hospital discharge, up to 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).</title>
        <description>Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).</description>
        <time_frame>Time from baseline through V03 (3 months)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).</title>
          <description>Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.91" lower_limit="58.72" upper_limit="99.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.</title>
        <description>Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.</description>
        <time_frame>30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.</title>
          <description>Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.</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="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).</title>
        <description>MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.</description>
        <time_frame>From surgery to end of study (2 years)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).</title>
          <description>MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.</description>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).</title>
        <description>All the adverse events reported were non-device related.</description>
        <time_frame>From surgery to end of study (2 years).</time_frame>
        <population>Due to the smaller than planned patient group size the descriptive statistics was used. Adverse events data is presented in Adverse Events section.</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).</title>
          <description>All the adverse events reported were non-device related.</description>
          <population>Due to the smaller than planned patient group size the descriptive statistics was used. Adverse events data is presented in Adverse Events section.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).</title>
        <time_frame>From surgery to end of study (2 years).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).</title>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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>Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).</title>
        <description>The occurrence, frequency and nature of abnormalities in any of the following:&#xD;
physical examination&#xD;
vital signs&#xD;
electrocardiography (ECG)&#xD;
echocardiography (ECHO)&#xD;
Laboratory tests&#xD;
Chest X-rays (taken only when clinically indicated)</description>
        <time_frame>From surgery to end of study (2 years).</time_frame>
        <population>The study was terminated prematurely. Due to the smaller than planned patient group size no sufficient data was collected for planned analysis of this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).</title>
          <description>The occurrence, frequency and nature of abnormalities in any of the following:&#xD;
physical examination&#xD;
vital signs&#xD;
electrocardiography (ECG)&#xD;
echocardiography (ECHO)&#xD;
Laboratory tests&#xD;
Chest X-rays (taken only when clinically indicated)</description>
          <population>The study was terminated prematurely. Due to the smaller than planned patient group size no sufficient data was collected for planned analysis of this endpoint.</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>Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.</title>
        <description>Success will be defined as no or only residual mitral regurgitation (MR).</description>
        <time_frame>Day of surgery visit (V01).</time_frame>
        <population>The data for this outcome measure was not collected.This was a part of the echocardiography investigation protocol and therefore was not documented on electronic case report form although the surgeon in charge performed the investigation on the operation table.</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.</title>
          <description>Success will be defined as no or only residual mitral regurgitation (MR).</description>
          <population>The data for this outcome measure was not collected.This was a part of the echocardiography investigation protocol and therefore was not documented on electronic case report form although the surgeon in charge performed the investigation on the operation table.</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>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).</title>
        <description>Measurement analysis at 24 months after successful MAR implantation.</description>
        <time_frame>V06 (24 months)</time_frame>
        <population>The study was terminated prematurely. Due to the smaller than planned patient group size no patient data at V04 (6 months) and V05 (12 months) was analyzed for this endpoint. The results provided are only for V06 (24 months).</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).</title>
          <description>Measurement analysis at 24 months after successful MAR implantation.</description>
          <population>The study was terminated prematurely. Due to the smaller than planned patient group size no patient data at V04 (6 months) and V05 (12 months) was analyzed for this endpoint. The results provided are only for V06 (24 months).</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="71.51" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.</title>
        <description>Change from screening at each follow-up visit in the following MR parameters, as measured using TTE:&#xD;
Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)&#xD;
Coaptation height</description>
        <time_frame>From screening to end of study (up to 2 years)</time_frame>
        <population>The outcome is reported for subjects and follow up visits where data is available</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.</title>
          <description>Change from screening at each follow-up visit in the following MR parameters, as measured using TTE:&#xD;
Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)&#xD;
Coaptation height</description>
          <population>The outcome is reported for subjects and follow up visits where data is available</population>
          <units>millimeters</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Left Ventricular Inner Dimension Systole 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" lower_limit="34" upper_limit="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Ventricular Inner Dimension Systole 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38" lower_limit="36" upper_limit="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Ventricular Inner Dimension Diastole 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="45" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Ventricular Inner Dimension Diastole 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51" lower_limit="49" upper_limit="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coaptation Height 3 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="2.7" upper_limit="12.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Coaptation Height 2 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" lower_limit="3.6" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.</title>
        <description>Duration of the following key stages of the annuloplasty procedure:&#xD;
MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness)&#xD;
MAR rotation time&#xD;
Suturing time (from start of annulus suturing until last knot)&#xD;
Aortic clamp time&#xD;
Cardiac arrest time</description>
        <time_frame>Day of surgery visit (V01)</time_frame>
        <population>MAR rotation time assessment available for 9 patients only.</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.</title>
          <description>Duration of the following key stages of the annuloplasty procedure:&#xD;
MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness)&#xD;
MAR rotation time&#xD;
Suturing time (from start of annulus suturing until last knot)&#xD;
Aortic clamp time&#xD;
Cardiac arrest time</description>
          <population>MAR rotation time assessment available for 9 patients only.</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Aortic clamp time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.2" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAR implantation time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Suturing time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAR rotation time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac arrest time</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.2" spread="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.</title>
        <time_frame>At screening and at each follow-up visit (except for discharge visit, up to 2 years).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 monts</title>
              <category_list>
                <category>
                  <title>Class I</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <title>Class I</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <category_list>
                <category>
                  <title>Class I</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 years</title>
              <category_list>
                <category>
                  <title>Class I</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class II</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class III</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Class IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.</title>
        <time_frame>Day of surgery visit (V01)</time_frame>
        <population>The leaflet measuring tool was designed to compress the leaflet between two jaws to measure the thickness. Due to soft tissue getting compressed between these two jaws the measure was not seen accurate, therefore this procedure was omitted in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Medtentia Annuloplasty Ring (MAR)</title>
            <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
          </group>
        </group_list>
        <measure>
          <title>Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.</title>
          <population>The leaflet measuring tool was designed to compress the leaflet between two jaws to measure the thickness. Due to soft tissue getting compressed between these two jaws the measure was not seen accurate, therefore this procedure was omitted in the study.</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>AEs documented from the point of surgery trough the follow-up (2 years).</time_frame>
      <desc>Common episodes during surgery (e.g. blood loss) and postoperative (e.g. pain, nausea, normal bruising) that are not considered clinically relevant by the Investigator should not be captured as AEs unless the event is worse than would normally be expected.&#xD;
Cases of excessive or abnormal bleeding or blood loss should be reported as AEs. Normal surgery-related laboratory test fluctuations common after surgery and not usually considered clinically significant are not considered to be AEs.</desc>
      <group_list>
        <group group_id="E1">
          <title>Medtentia Annuloplasty Ring (MAR)</title>
          <description>Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.0)</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="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Residual mitral regurgitation leading to re-operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Takotsubo cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation worsening</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Peritonsilitis l.dx</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Urinary tract infection/ urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Increased white blood cell count</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pre-symptomatic migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (19.0)</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="8" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation worsening</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia episode</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <description>Reported adverse event terms: Wound infection, left leg donor site and Minor wound infection.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Common cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma bronchiale</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Pulmonary congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated prematurely. The smaller than planned patient group size did not allow testing the study hypothesis in full. Due to the limited number of patients only descriptive statistics were used.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Olli Keränen / CEO</name_or_title>
      <organization>Medtentia International Ltd Oy</organization>
      <phone>+358 50 3567090</phone>
      <email>ok@medtentia.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/NCT01678144
org study id: 2010-040
nct id: NCT01678144
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the trial is to demonstrate the safety and performance of the Medtentia
      Annuloplasty Ring (MAR) during mitral valve repair surgery. In addition, the trial aims to
      demonstrate that the MAR fulfills the requirements for mitral valve annuloplasty rings.
The purpose of this study is to evaluate the safety and performance of the MAR in patients
      with mitral regurgitation requiring either isolated mitral valve annuloplasty or mitral valve
      annuloplasty concomitantly with any of the following, either individually or in combination:

        -  Tricuspid valve repair

        -  Coronary artery bypass grafting (CABG)

        -  Valve resection and chordae repair

        -  Correction of atrial septal defect

        -  Correction of patent foramen ovale

        -  Ablation therapy for atrial defibrillation
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, multi-national, multi-center, open-label, single-arm
primary purpose: Treatment
masking: None (Open Label)
measure: Safety: All-cause Mortality Occurring in the Time From Surgery Through Hospital Discharge.
time frame: Time from surgery through hospital discharge, up to 7 days.
measure: Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes From Baseline (SC) to Three Months (V03) as Measured by Trans-thoracic Echocardiography (TTE).
time frame: Time from baseline through V03 (3 months)
description: Success will be defined as an improvement in at least 2 degrees in mitral regurgitation (MR) class as described in the ACC/AHA Guidelines for the Management of Patients with Valvular Heart Disease (Bonow, et al., 2008).
measure: Safety: 30-day Mortality and Mortality at 3 Months, 6 Months, 1 Year, 1.5 Years and 2 Years.
time frame: 30 days, 3 months, 6 months, 1 year, 1.5 years and 2 years after surgery
description: Mortality rates determined both for all-cause mortality and for related deaths only. For the former, the causality status will be determined by the Investigator, and all deaths that are clearly unrelated to the device, the surgery or the underlying medical condition will be excluded from the analysis.
measure: Safety: The Occurrence, Frequency and Timing of Treatment-emergent Major Adverse Cardiac Events (MACEs).
time frame: From surgery to end of study (2 years)
description: MACE is defined as stroke and clinically significant myocardial infarction (MI), from surgery to end of study.
measure: Safety: The Occurrence, Nature and Frequency of Treatment-emergent Adverse Events (AEs), in Particular Severe Serious Adverse Device Effects (SADEs).
time frame: From surgery to end of study (2 years).
description: All the adverse events reported were non-device related.
measure: Safety: The Occurrence, Nature and Frequency of Device Deficiencies and Adverse Device Effects (ADEs).
time frame: From surgery to end of study (2 years).
measure: Safety: The Occurrence, Frequency and Nature of Abnormalities in the Period From Surgery Through Follow-up (Detailed List in Description Field).
time frame: From surgery to end of study (2 years).
description: The occurrence, frequency and nature of abnormalities in any of the following:
physical examination
vital signs
electrocardiography (ECG)
echocardiography (ECHO)
Laboratory tests
Chest X-rays (taken only when clinically indicated)
measure: Performance: Mitral Regurgitation (MR) as Seen in Trans-esophageal Echocardiography (TEE) Performed During Surgery Before and After Annuloplasty.
time frame: Day of surgery visit (V01).
description: Success will be defined as no or only residual mitral regurgitation (MR).
measure: Performance: Percentage of Participants With Improvement by at Least 2 Mitral Regurgitation Classes at Each Follow-up Visit (V04-V06) of the Improvement in MR From Screening, as Measured by Trans-thoracic Echocardiography (TTE).
time frame: V06 (24 months)
description: Measurement analysis at 24 months after successful MAR implantation.
measure: Exploratory: Change in the Mitral Regurgitation (MR) Parameters, as Measured Using TTE.
time frame: From screening to end of study (up to 2 years)
description: Change from screening at each follow-up visit in the following MR parameters, as measured using TTE:
Left ventricular inner dimension systole and diastole assessment by trans-thoracic echocardiography (the dimension of inner edge to inner edge, perpendicular to the long axis of the left ventricle, at the level of the mitral valve leaflet tips, measured at end-systole and end-diastole)
Coaptation height
measure: Exploratory: Duration of the Key Stages of the Annuloplasty Procedure.
time frame: Day of surgery visit (V01)
description: Duration of the following key stages of the annuloplasty procedure:
MAR implantation time (beginning with the measurement of the annulus size and ending with the completion of the last suture, but not including the time needed to measure leaflet thickness)
MAR rotation time
Suturing time (from start of annulus suturing until last knot)
Aortic clamp time
Cardiac arrest time
measure: Exploratory: Changes From Screening in NYHA Classification at All Follow-up Visits Except Discharge.
time frame: At screening and at each follow-up visit (except for discharge visit, up to 2 years).
measure: Exploratory: Thickness of the Anterior Leaflet Segment A2 and the Posterior Scallop P2 of the Mitral Valve (MV) Leaflets, as Measured With the Dedicated Medtentia Leaflet Measurement Tool.
time frame: Day of surgery visit (V01)
arm group label: Medtentia Annuloplasty Ring (MAR)
arm group type: Experimental
description: All eligible patients underwent surgical mitral valve repair using annuloplasty device - Medtentia Annuloplasty Ring (MAR)
intervention type: Device
intervention name: Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)
arm group label: Medtentia Annuloplasty Ring (MAR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Kalervo Werkkala, M.D., Prof.
role: Principal Investigator
affiliation: Helsinki University Central Hospital
facility: 
country: Finland
url: https://medtentia.com
description: Medtentia Company Webpage
citation: Konerding MA, Simpanen J, Ihlberg L, Aittomaki J, Werkkala K, Delventhal V, Ackermann M. Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model. J Cardiothorac Surg. 2013 Apr 8;8:70. doi: 10.1186/1749-8090-8-70.
PMID: 23566678
citation: Jensen H, Simpanen J, Smerup M, Bjerre M, Bramsen M, Werkkala K, Vainikka T, Hasenkam JM, Wierup P. Medtentia double helix mitral annuloplasty system evaluated in a porcine experimental model. Innovations (Phila). 2010 Mar;5(2):114-7. doi: 10.1097/IMI.0b013e3181d84316.
PMID: 22437358
responsible party type: Sponsor
mesh term: Mitral Valve Insufficiency
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated prematurely. The smaller than planned patient group size did not allow testing the study hypothesis in full. Due to the limited number of patients only descriptive statistics were used.
point of contact: 