<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/NCT03004599</url>
  </required_header>
  <id_info>
    <org_study_id>MH-P-002</org_study_id>
    <nct_id>NCT03004599</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis</brief_title>
  <official_title>Safety and Efficacy of SYM-SV/DS-002 in Patients With Severe Aortic Stenosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medico's Hirata Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medico's Hirata Inc.</source>
  <brief_summary>
    <textblock>
      Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation&#xD;
      using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients&#xD;
      presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo&#xD;
      conventional surgical aortic valve replacement (AVR)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the business issues. Manufacturer has been acquired by other company.&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>at 12 months post-procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence rates of MACCE</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>MACCE is defined as a composite of:&#xD;
All Cause Mortality&#xD;
Myocardial infarction (MI)&#xD;
All Stroke&#xD;
Reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence rates of individual MACCE components</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Individual MACCE components include:&#xD;
All Cause Mortality&#xD;
Myocardial infarction (MI)&#xD;
All Stroke&#xD;
Reintervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence rates of Major Adverse Events (MAEs)</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>MAEs include:&#xD;
MACCE&#xD;
Acute Kidney Injury (AKI)&#xD;
Cardiac Tamponade&#xD;
Prosthetic Valve Dysfunction (PVD)&#xD;
Cardiogenic Shock&#xD;
Prosthetic Valve Endocarditis&#xD;
Life-Threatening, Disabling or Major Bleeding&#xD;
Major Vascular Complications&#xD;
Cardiac Perforation&#xD;
Device Migration/Valve Embolism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence rate of conduction disturbance requiring Permanent Pacemaker Implantation(PPI)</measure>
    <time_frame>at 1 month, 6 month, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NYHA class from baseline</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in distance walked during 6-Minute Walk Test (6MWT) from baseline</measure>
    <time_frame>at 1 month and 12 month post-procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL from baseline</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Kansas City Cardiomyopathy Questionnaire (KCCQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL from baseline</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>SF-36</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Effective Orifice Area Index (EOAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Mean gradient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Degree of Aortic valve Regurgitation (AR) (Transvalvular and Paravalvular)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Echocardiographic assessment of valve performance</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Left ventricular ejection fraction (LVEF)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device success</measure>
    <time_frame>Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)</time_frame>
    <description>Device success is defined as that all of the following are achieved:&#xD;
Successful vascular access&#xD;
Successful delivery and deployment of the device&#xD;
Successful retrieval of the delivery system&#xD;
Correct position of the device in the proper anatomical location (placement in the aortic annulus with no impedance on device function)&#xD;
Intended performance of the prosthetic heart valve is confirmed by echocardiography (defined as below):&#xD;
No Patient-Prosthesis Mismatch (PPM) (EOAI &gt;0.85cm2/m2)&#xD;
And mean aortic valve gradient &lt; 20 mmHg or peak velocity &lt; 3 m/sec,&#xD;
And no moderate or severe prosthetic valve regurgitation&#xD;
Only one valve implanted in the proper anatomical location</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural success</measure>
    <time_frame>Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)</time_frame>
    <description>Procedural success is defined as that all of the following are achieved:&#xD;
Achievement of the device success&#xD;
Absence of in-hospital MACCE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence rate of Prosthetic Valve Dysfunction (PVD)</measure>
    <time_frame>at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure</time_frame>
    <description>Prosthetic Valve Dysfunction (PVD) is defined as:&#xD;
Aortic regurgitation (AR) reported as moderate or severe by echocardiography assessments&#xD;
Significant aortic stenosis (AS) which meets one or more of the following by echocardiography assessments:&#xD;
Peak velocity &gt; 4 m/s&#xD;
Mean gradient &gt; 35 mmHg&#xD;
Effective Orifice Area (EOA) &lt; 0.8 cm2&#xD;
TVIV1／TVIV2 &lt; 0.25</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence rate of clinical endpoints per VARC 2</measure>
    <time_frame>at 1 month post-procedure</time_frame>
    <description>Mortality&#xD;
Stroke&#xD;
Myocardial infarction (MI)&#xD;
Bleeding complications&#xD;
Acute kidney injury (AKI)&#xD;
Vascular complications&#xD;
Conduction disturbances and arrhythmia&#xD;
Other TAVI-related complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Severe Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Transcatheter Aortic Valve Implantation (TAVI)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System</intervention_name>
    <description>Transcatheter Aortic Valve Implantation via Transfemoral Approach</description>
    <arm_group_label>Transcatheter Aortic Valve Implantation (TAVI)</arm_group_label>
    <other_name>ACURATE neo™ Aortic Bioprosthesis</other_name>
    <other_name>ACURATE TF™ Transfemoral Delivery System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least one cardiologist and one cardiac surgeon agree that it is difficult for the&#xD;
             patient to receive a surgical procedure due to medical factors such that the subject&#xD;
             has various comorbidities and he/she is more likely to die or suffer from severe&#xD;
             diseases than to have significant improvements by a surgical procedure.&#xD;
&#xD;
          2. Subject has senile degenerative aortic valve stenosis with:&#xD;
&#xD;
               -  mean gradient &gt; 40 mmHg, or maximum jet velocity greater than 4.0 m/sec by either&#xD;
                  resting or dobutamine stress echocardiogram, or simultaneous pressure recordings&#xD;
                  at cardiac catheterization&#xD;
&#xD;
               -  AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5&#xD;
                  cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac&#xD;
                  catheterization&#xD;
&#xD;
          3. Subject is symptomatic from his/her aortic valve stenosis (AS), as demonstrated by New&#xD;
             York Heart Association (NYHA) Functional Class II or greater.&#xD;
&#xD;
          4. The subject has been informed of the nature of this trial, agrees to its provisions&#xD;
             and has provided written informed consent as approved by the IRB of the respective&#xD;
             clinical site.&#xD;
&#xD;
          5. The subject or the subject's legal representative agrees to visit the site where&#xD;
             he/she receives index procedure for all required post-procedure follow-ups.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Evidence of an acute myocardial infarction ≤ 30 days (The procedure day is counted as&#xD;
             day 0.) before the implant procedure&#xD;
&#xD;
          2. Any percutaneous coronary or peripheral interventional procedures, including&#xD;
             placements of bare metal stents are performed within 30 days prior to the implant&#xD;
             procedure, or any drug eluting stents are placed within 6 months (One month is counted&#xD;
             as 30 days.) prior to the implant procedure&#xD;
&#xD;
          3. Untreated clinically significant coronary artery disease (CAD) requiring&#xD;
             revascularization&#xD;
&#xD;
          4. Blood dyscrasias as defined:&#xD;
&#xD;
             leukopenia (WBC &lt; 1,000/mm3), thrombocytopenia (platelet count &lt;50,000 cells/mm3),&#xD;
             history of bleeding diathesis or coagulopathy&#xD;
&#xD;
          5. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or&#xD;
             mechanical hemodynamic support&#xD;
&#xD;
          6. Need for emergency surgery for any reason&#xD;
&#xD;
          7. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) &lt; 20% as&#xD;
             measured by resting echocardiogram&#xD;
&#xD;
          8. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months&#xD;
             prior to the implant procedure (except mild TIA related to aortic stenosis)&#xD;
&#xD;
          9. End stage renal disease requiring chronic dialysis or serum creatinine &gt; 3.0 mg/dL&#xD;
&#xD;
         10. Active Gastrointestinal (GI) bleeding within 3 months prior to the implant procedure&#xD;
&#xD;
         11. A known hypersensitivity or contraindication to any of the following which cannot be&#xD;
             adequately pre-medicated:&#xD;
&#xD;
               -  Aspirin&#xD;
&#xD;
               -  Heparin (HIT/HITTS)&#xD;
&#xD;
               -  Nitinol (titanium or nickel)&#xD;
&#xD;
               -  P2Y12 inhibitors (such as Ticlopidine etc.)&#xD;
&#xD;
               -  Contrast media&#xD;
&#xD;
         12. Ongoing sepsis, including active endocarditis&#xD;
&#xD;
         13. Subject refuses a blood transfusion&#xD;
&#xD;
         14. Life expectancy &lt; 12 months due to associated non-cardiac comorbid conditions&#xD;
&#xD;
         15. Other medical, social, or psychological conditions that in the opinion of a principal&#xD;
             investigator or sub-investigator precludes the subject from appropriate consent&#xD;
&#xD;
         16. Severe dementia (unable to provide informed consent for the treatment/procedure,&#xD;
             unable to live an independent life outside of a chronic care facility, or expected to&#xD;
             be fundamentally unable to undergo rehabilitation after the procedure, or unable to&#xD;
             come to the site for follow-up visits)&#xD;
&#xD;
         17. Currently participating in other trials of investigational drugs or other&#xD;
             investigational devices&#xD;
&#xD;
         18. Native aortic annulus size &lt; 21 mm or &gt; 27 mm per the baseline diagnostic imaging&#xD;
&#xD;
         19. Pre-existing prosthetic heart valve and / or prosthetic ring in any position&#xD;
&#xD;
         20. Mixed aortic valve disease (aortic stenosis and predominant aortic regurgitation&#xD;
             (3-4+))&#xD;
&#xD;
         21. Moderate to severe (3-4+) or severe (4+) mitral regurgitation or severe (4+) tricuspid&#xD;
             regurgitation&#xD;
&#xD;
         22. Moderate to severe mitral stenosis&#xD;
&#xD;
         23. Hypertrophic obstructive cardiomyopathy&#xD;
&#xD;
         24. New or untreated echocardiographic evidence of intracardiac mass, thrombus or&#xD;
             vegetation&#xD;
&#xD;
         25. Congenital bicuspid or unicuspid valve verified by echocardiograph&#xD;
&#xD;
         26. Extreme eccentric calcification of the native aortic valve&#xD;
&#xD;
         27. Transesophageal echocardiogram (TEE) is contraindicated.&#xD;
&#xD;
         28. Scheduled surgical or percutaneous procedure to be performed prior to 1-month visit&#xD;
             post-implant procedure&#xD;
&#xD;
         29. Hepatic failure (Child C or more)&#xD;
&#xD;
         30. Aortic or peripheral condition NOT appropriate for transfemoral implant due to the&#xD;
             size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral&#xD;
             arteries&#xD;
&#xD;
         31. Thoracic or abdominal aortic aneurysm&#xD;
&#xD;
         32. Woman who is pregnant, breastfeeding or willing to become pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kokura Memorial Hospital</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>802-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sakakibara Heart Institute</name>
      <address>
        <city>Fuchu</city>
        <state>Tokyo</state>
        <zip>183-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Itabashi</city>
        <state>Tokyo</state>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku</city>
        <state>Tokyo</state>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Valvular Heart Disease</keyword>
  <keyword>Critical Aortic Stenosis</keyword>
  <keyword>Severe Aortic Stenosis</keyword>
  <keyword>High Risk</keyword>
  <keyword>Aortic Valve Replacement</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Heart Valve Therapy</keyword>
  <keyword>Transcatheter</keyword>
  <keyword>Transfemoral</keyword>
  <keyword>TAVI</keyword>
  <keyword>TAVR</keyword>
  <keyword>ACURATE neo™ Aortic Bioprosthesis</keyword>
  <keyword>ACURATE TF™ Transfemoral Delivery System</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Constriction, Pathologic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03004599
org study id: MH-P-002
nct id: NCT03004599
lead sponsor: 
Safety and Efficacy of SYM-SV/DS-002 in Patients with Severe Aortic Stenosis
To evaluate the safety and efficacy of Transfemoral Transcatheter Aortic Valve Implantation
      using SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System in patients
      presenting with symptomatic severe aortic stenosis and with difficulty to safely undergo
      conventional surgical aortic valve replacement (AVR)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival rate
time frame: at 12 months post-procedure
measure: Occurrence rates of MACCE
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: MACCE is defined as a composite of:
All Cause Mortality
Myocardial infarction (MI)
All Stroke
Reintervention
measure: Occurrence rates of individual MACCE components
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Individual MACCE components include:
All Cause Mortality
Myocardial infarction (MI)
All Stroke
Reintervention
measure: Occurrence rates of Major Adverse Events (MAEs)
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: MAEs include:
MACCE
Acute Kidney Injury (AKI)
Cardiac Tamponade
Prosthetic Valve Dysfunction (PVD)
Cardiogenic Shock
Prosthetic Valve Endocarditis
Life-Threatening, Disabling or Major Bleeding
Major Vascular Complications
Cardiac Perforation
Device Migration/Valve Embolism
measure: Occurrence rate of conduction disturbance requiring Permanent Pacemaker Implantation(PPI)
time frame: at 1 month, 6 month, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
measure: Change in NYHA class from baseline
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
measure: Change in distance walked during 6-Minute Walk Test (6MWT) from baseline
time frame: at 1 month and 12 month post-procedure
measure: Change in QOL from baseline
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Kansas City Cardiomyopathy Questionnaire (KCCQ)
measure: Change in QOL from baseline
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: SF-36
measure: Echocardiographic assessment of valve performance
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Effective Orifice Area Index (EOAI)
measure: Echocardiographic assessment of valve performance
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Mean gradient
measure: Echocardiographic assessment of valve performance
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Degree of Aortic valve Regurgitation (AR) (Transvalvular and Paravalvular)
measure: Echocardiographic assessment of valve performance
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Left ventricular ejection fraction (LVEF)
measure: Device success
time frame: Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)
description: Device success is defined as that all of the following are achieved:
Successful vascular access
Successful delivery and deployment of the device
Successful retrieval of the delivery system
Correct position of the device in the proper anatomical location (placement in the aortic annulus with no impedance on device function)
Intended performance of the prosthetic heart valve is confirmed by echocardiography (defined as below):
No Patient-Prosthesis Mismatch (PPM) (EOAI >0.85cm2/m2)
And mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec,
And no moderate or severe prosthetic valve regurgitation
Only one valve implanted in the proper anatomical location
measure: Procedural success
time frame: Number of days from admission to discharge (estimated to be at 7 days post-procedure on average)
description: Procedural success is defined as that all of the following are achieved:
Achievement of the device success
Absence of in-hospital MACCE
measure: Occurrence rate of Prosthetic Valve Dysfunction (PVD)
time frame: at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years post-procedure
description: Prosthetic Valve Dysfunction (PVD) is defined as:
Aortic regurgitation (AR) reported as moderate or severe by echocardiography assessments
Significant aortic stenosis (AS) which meets one or more of the following by echocardiography assessments:
Peak velocity > 4 m/s
Mean gradient > 35 mmHg
Effective Orifice Area (EOA) < 0.8 cm2
TVIV1／TVIV2 < 0.25
measure: Occurrence rate of clinical endpoints per VARC 2
time frame: at 1 month post-procedure
description: Mortality
Stroke
Myocardial infarction (MI)
Bleeding complications
Acute kidney injury (AKI)
Vascular complications
Conduction disturbances and arrhythmia
Other TAVI-related complications
arm group label: Transcatheter Aortic Valve Implantation (TAVI)
arm group type: Other
intervention type: Device
intervention name: SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System
description: Transcatheter Aortic Valve Implantation via Transfemoral Approach
arm group label: Transcatheter Aortic Valve Implantation (TAVI)
other name: ACURATE neo™ Aortic Bioprosthesis
other name: ACURATE TF™ Transfemoral Delivery System
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Constriction, Pathologic