<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/NCT03043404</url>
  </required_header>
  <id_info>
    <org_study_id>S2321</org_study_id>
    <nct_id>NCT03043404</nct_id>
  </id_info>
  <brief_title>Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System</brief_title>
  <official_title>REPRISE II FLEX: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With a FLEXible Delivery System - Confirmation of Performance and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</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>
      To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter&#xD;
      aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis&#xD;
      who are considered high risk for surgical valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical study is a prospective, single-arm study designed to confirm that the acute&#xD;
      performance and safety of the Lotus Valve Flex System for TAVR are consistent with the&#xD;
      results of the Lotus Valve System in the REPRISE II study, when delivered and deployed in&#xD;
      symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk&#xD;
      for surgical aortic valve replacement (SAVR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2013</start_date>
  <completion_date type="Actual">December 10, 2018</completion_date>
  <primary_completion_date type="Actual">December 10, 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical success</measure>
    <time_frame>immediately post-procedure</time_frame>
    <description>defined as successful vascular access, delivery and deployment of the Lotus Valve and successful retrieval of the delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location; reported as percent of subjects.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean aortic valve pressure gradient and effective orifice area</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>as measured by echocardiography and assessed by an independent core laboratory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device performance</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first)</time_frame>
    <description>defined as successful repositioning of the Lotus Valve if repositioning is attempted; and successful retrieval of the Lotus Valve if retrieval is attempted; and grade of paravalvular aortic regurgitation, as measured by echocardiography and assessed by an independent core laboratory</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mortality: all-cause, cardiovascular, and non-cardiovascular</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Stroke: disabling and non-disabling</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Composite of all-cause mortality and disabling stroke</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding: life-threatening (or disabling) and major</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial infarction (MI)</measure>
    <time_frame>periprocedural (≤72 hours post index procedure) and spontaneous (&gt;72 hours post index procedure)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Acute kidney injury: based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2</measure>
    <time_frame>≤7 days post index procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Major vascular complication</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Repeat procedure for valve-related dysfunction (surgical or interventional therapy)</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>New permanent pacemaker implantation resulting from new or worsened conduction disturbances (including new left bundle branch block [LBBB] and third degree atrioventricular block)</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>New onset of atrial fibrillation or atrial flutter</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Coronary obstruction</measure>
    <time_frame>≤7 days post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Ventricular septal perforation, reported as percent of subjects</measure>
    <time_frame>≤7 days post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Mitral apparatus damage, reported as percent of subjects</measure>
    <time_frame>≤7 days post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac tamponade, reported as percent of subjects</measure>
    <time_frame>≤7 days post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Prosthetic aortic valve malposition, including valve migration, valve embolization, ectopic valve deployment, or transcatheter aortic valve (TAV)-in-TAV deployment</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Prosthetic aortic valve thrombosis</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Prosthetic aortic valve endocarditis</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Prosthetic aortic valve performance</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
    <description>as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional status</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
    <description>as evaluated by the New York Heart Association (NYHA) classification</description>
  </other_outcome>
  <other_outcome>
    <measure>Neurological status</measure>
    <time_frame>at discharge and 1 year</time_frame>
    <description>as determined by the National Institutes of Health Stroke Scale (NIHSS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Neurological status</measure>
    <time_frame>at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure</time_frame>
    <description>as determined by the Modified Rankin Scale (mRS)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Lotus Valve Flex System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter aortic valve replacement (TAVR) with Lotus Valve FLEX System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter aortic valve replacement</intervention_name>
    <description>TAVR with Lotus Valve Flex System</description>
    <arm_group_label>Lotus Valve Flex System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subject is ≥70 years of age&#xD;
&#xD;
          -  2. Subject has documented calcific native aortic valve stenosis with an initial aortic&#xD;
             valve area (AVA) of &lt;1.0 cm2 (or AVA index of &lt;0.6 cm2/m2) and either a mean pressure&#xD;
             gradient &gt;40 mm Hg or a jet velocity &gt;4 m/s, as measured by echocardiography&#xD;
&#xD;
          -  3. Subject has a documented aortic annulus size between ≥20 and ≤27 mm based on&#xD;
             pre-procedure diagnostic imaging&#xD;
&#xD;
          -  4. Symptomatic aortic valve stenosis with NYHA Functional Class ≥ II&#xD;
&#xD;
          -  5. Subject is considered high risk for surgical valve replacement based on at least&#xD;
             one of the following:&#xD;
&#xD;
               1. Society of Thoracic Surgeons (STS) score ≥8%, AND/OR&#xD;
&#xD;
               2. Agreement by the heart team (which must include an in-person evaluation by an&#xD;
                  experienced cardiac surgeon) that subject is at high operative risk of serious&#xD;
                  morbidity or mortality with surgical valve replacement&#xD;
&#xD;
          -  6. Heart team (which must include an experienced cardiac surgeon) assessment that the&#xD;
             subject is likely to benefit from valve replacement.&#xD;
&#xD;
          -  7. Subject (or legal representative) understands the study requirements and the&#xD;
             treatment procedures, and provides written informed consent.&#xD;
&#xD;
          -  8. Subject, family member, and/or legal representative agree(s) and subject is capable&#xD;
             of returning to the study hospital for all required scheduled follow up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has a congenital unicuspid or bicuspid aortic valve.&#xD;
&#xD;
          2. Subject with an acute myocardial infarction within 30 days of the index procedure&#xD;
             (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the&#xD;
             presence of CK-MB elevation and/or troponin elevation).&#xD;
&#xD;
          3. Subject has had a cerebrovascular accident or transient ischemic attack within the&#xD;
             past 6 months, or has any permanent neurologic defect prior to study enrollment.&#xD;
&#xD;
          4. Subject is on dialysis or has serum creatinine level &gt;3.0 mg/dL or 265 µmol/L.&#xD;
&#xD;
          5. Subject has a pre-existing prosthetic heart valve (aortic or mitral) or a prosthetic&#xD;
             ring in any position.&#xD;
&#xD;
          6. Subject has ≥3+ mitral regurgitation, ≥3+ aortic regurgitation or ≥3+ tricuspid&#xD;
             regurgitation (i.e., subject cannot have more than moderate mitral, aortic or&#xD;
             tricuspid regurgitation).&#xD;
&#xD;
          7. Subject has a need for emergency surgery for any reason.&#xD;
&#xD;
          8. Subject has a history of endocarditis within 12 months of index procedure or evidence&#xD;
             of an active systemic infection or sepsis.&#xD;
&#xD;
          9. Subject has echocardiographic evidence of intra-cardiac mass, thrombus or vegetation.&#xD;
&#xD;
         10. Subject has Hgb &lt;9 g/dL, platelet count &lt;50,000 cells/mm3 or &gt;700,000 cells/mm3, or&#xD;
             white blood cell count &lt;1,000 cells/mm3.&#xD;
&#xD;
         11. Subject requires chronic anticoagulation therapy (warfarin) and cannot tolerate&#xD;
             concomitant therapy with either aspirin or clopidogrel.&#xD;
&#xD;
             Note: Subjects who require chronic anticoagulation must be able to be treated&#xD;
             additionally with either aspirin or clopidogrel. An alternative P2Y12 inhibitor may be&#xD;
             prescribed if subject is allergic to or intolerant of clopidogrel.&#xD;
&#xD;
         12. Subject has active peptic ulcer disease or gastrointestinal bleed within the past 3&#xD;
             months, other bleeding diathesis or coagulopathy or will refuse transfusions.&#xD;
&#xD;
         13. Subject has known hypersensitivity to contrast agents that cannot be adequately&#xD;
             pre-medicated, or has known hypersensitivity to aspirin, all thienopyridines, heparin,&#xD;
             nickel, tantalum, titanium, or polyurethanes.&#xD;
&#xD;
         14. Subject has a life expectancy of less than 12 months due to non-cardiac, co-morbid&#xD;
             conditions based on the assessment of the investigator at the time of enrollment.&#xD;
&#xD;
         15. Subject has hypertrophic obstructive cardiomyopathy.&#xD;
&#xD;
         16. Subject has any therapeutic invasive cardiac procedure (including balloon aortic&#xD;
             valvuloplasty) within 30 days prior to the index procedure (except for pacemaker&#xD;
             implantation which is allowed).&#xD;
&#xD;
         17. Subject has untreated coronary artery disease, which in the opinion of the treating&#xD;
             physician is clinically significant and requires revascularization.&#xD;
&#xD;
         18. Subject has documented left ventricular ejection fraction &lt;30%.&#xD;
&#xD;
         19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic&#xD;
             support or mechanical support devices.&#xD;
&#xD;
         20. Subject has severe peripheral vascular disease (including aneurysm defined as maximal&#xD;
             luminal diameter &gt;5 cm or with documented presence of thrombus, marked tortuosity,&#xD;
             narrowing of the abdominal aorta, severe unfolding of the thoracic aorta or thick [&gt;5&#xD;
             mm], protruding or ulcerated atheroma in the aortic arch) or symptomatic carotid or&#xD;
             vertebral disease.&#xD;
&#xD;
         21. Femoral artery lumen of &lt;6.0 mm for subjects requiring 23 mm valve size or &lt;6.5 mm for&#xD;
             subjects requiring 27 mm valve size, or severe iliofemoral tortuosity or calcification&#xD;
             that would prevent safe placement of the introducer sheath.&#xD;
&#xD;
         22. Current problems with substance abuse (e.g., alcohol, etc.).&#xD;
&#xD;
         23. Subject is participating in another investigational drug or device study that has not&#xD;
             reached its primary endpoint.&#xD;
&#xD;
         24. Subject has untreated conduction system disorder (e.g., Type II second degree&#xD;
             atrioventricular block) that in the opinion of the treating physician is clinically&#xD;
             significant and requires a pacemaker implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian T Meredith, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Monash</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Heart</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 1, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043404
org study id: S2321
nct id: NCT03043404
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter
      aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis
      who are considered high risk for surgical valve replacement.
This clinical study is a prospective, single-arm study designed to confirm that the acute
      performance and safety of the Lotus Valve Flex System for TAVR are consistent with the
      results of the Lotus Valve System in the REPRISE II study, when delivered and deployed in
      symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk
      for surgical aortic valve replacement (SAVR).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical success
time frame: immediately post-procedure
description: defined as successful vascular access, delivery and deployment of the Lotus Valve and successful retrieval of the delivery system; and correct positioning of a single Lotus Valve in the proper anatomical location; reported as percent of subjects.
measure: Mean aortic valve pressure gradient and effective orifice area
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: as measured by echocardiography and assessed by an independent core laboratory
measure: Device performance
time frame: at discharge or 7 days post-procedure (whichever comes first)
description: defined as successful repositioning of the Lotus Valve if repositioning is attempted; and successful retrieval of the Lotus Valve if retrieval is attempted; and grade of paravalvular aortic regurgitation, as measured by echocardiography and assessed by an independent core laboratory
measure: Mortality: all-cause, cardiovascular, and non-cardiovascular
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Stroke: disabling and non-disabling
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Composite of all-cause mortality and disabling stroke
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Bleeding: life-threatening (or disabling) and major
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Myocardial infarction (MI)
time frame: periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)
measure: Acute kidney injury: based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2
time frame: ≤7 days post index procedure
measure: Major vascular complication
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: New permanent pacemaker implantation resulting from new or worsened conduction disturbances (including new left bundle branch block [LBBB] and third degree atrioventricular block)
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: New onset of atrial fibrillation or atrial flutter
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Coronary obstruction
time frame: ≤7 days post procedure
measure: Ventricular septal perforation, reported as percent of subjects
time frame: ≤7 days post procedure
measure: Mitral apparatus damage, reported as percent of subjects
time frame: ≤7 days post procedure
measure: Cardiac tamponade, reported as percent of subjects
time frame: ≤7 days post procedure
measure: Prosthetic aortic valve malposition, including valve migration, valve embolization, ectopic valve deployment, or transcatheter aortic valve (TAV)-in-TAV deployment
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Prosthetic aortic valve thrombosis
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Prosthetic aortic valve endocarditis
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
measure: Prosthetic aortic valve performance
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
description: as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory, including effective orifice area, mean and peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation
measure: Functional status
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
description: as evaluated by the New York Heart Association (NYHA) classification
measure: Neurological status
time frame: at discharge and 1 year
description: as determined by the National Institutes of Health Stroke Scale (NIHSS)
measure: Neurological status
time frame: at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and 1, 2, 3, 4, and 5 years post procedure
description: as determined by the Modified Rankin Scale (mRS)
arm group label: Lotus Valve Flex System
arm group type: Experimental
description: Transcatheter aortic valve replacement (TAVR) with Lotus Valve FLEX System
intervention type: Device
intervention name: Transcatheter aortic valve replacement
description: TAVR with Lotus Valve Flex System
arm group label: Lotus Valve Flex System
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Ian T Meredith, MD, PhD
role: Principal Investigator
affiliation: Monash
facility: 
facility: 
country: Australia
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No