<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/NCT02207569</url>
  </required_header>
  <id_info>
    <org_study_id>10126779DOC</org_study_id>
    <nct_id>NCT02207569</nct_id>
  </id_info>
  <brief_title>Medtronic CoreValve Evolut R U.S. Clinical Study</brief_title>
  <official_title>Medtronic CoreValve Evolut R United States IDE Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiovascular</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study objectives are to assess the safety and efficacy of the CoreValve Evolut R&#xD;
      transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic&#xD;
      aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This objective will be accomplished by a prospective, single arm, historical controlled,&#xD;
      multi-site study involving a minimum of 150 implanted subjects with no more than 250&#xD;
      implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety&#xD;
      and efficacy results from this study will be compared to appropriate historical control data&#xD;
      for the Medtronic CoreValve System. Subjects will be followed up to 5 years following&#xD;
      implantation.&#xD;
&#xD;
      The enrollment phase of the study is estimated to take approximately 6-9 months. As each&#xD;
      implanted subject is to be followed up to 5 years, the estimated study duration is&#xD;
      approximately 66-69 months, excluding the time required for preparing the final report.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 28, 2020</completion_date>
  <primary_completion_date type="Actual">August 2015</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>All-cause Mortality at 30 Days by Percent</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Percentage of patients that died by any cause at 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Disabling Stroke at 30 Days</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Stroke Diagnostic Criteria:&#xD;
&gt;&#xD;
Acute episode of focal or global neurological deficit with at least 2 of the following:&#xD;
change in level of consciousness &gt;&#xD;
hemiplegia, hemiparesis&#xD;
numbness or sensory loss affecting 1 side &gt;&#xD;
dysphasia or aphasia&#xD;
hemianopia&#xD;
amaurosis fugax &gt;&#xD;
other neurological signs or symptoms consistent with stroke&#xD;
2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist&#xD;
3.) Confirmation of the diagnosis by at least 1 of the following:&#xD;
Neurological specialist &gt;&#xD;
Neuroimaging procedure, or on clincial grounds alone &gt; Stroke: durations of neural deficit &gt; 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death&#xD;
Defined by VARC II:&#xD;
&gt; An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Device Success Rate Between 24 and 7 Day</measure>
    <time_frame>Assessed at 24 hours to seven days post implantation</time_frame>
    <description>Percentage of patients with Device Success defined as:&#xD;
Absence of procedural mortality, AND&#xD;
Correct positioning of a single Evolut R valve into the proper anatomical location, AND&#xD;
Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity &lt; 3m/sec, AND&#xD;
Absence of moderate or severe prosthetic valve regurgitation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)</measure>
    <time_frame>Assessed at 24 hours to 7 days post implantation</time_frame>
    <description>Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coronary Artery Obstruction Requiring Intervention.</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent VARC II Combined Safety Endpoint at 30 Days</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>VARC II composite safety endpoint rate includes percent freedom from the following components:&#xD;
All-cause mortality&#xD;
All stroke (disabling and non-disabling)&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury: stage 2 or 3 (including renal replacement therapy).&#xD;
Coronary artery obstruction requiring intervention.&#xD;
Major vascular complication.&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Stage 2&#xD;
Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR&#xD;
&gt;&#xD;
Urine output &lt;0.5 mL/kg/h for &gt;12 but &lt;24 h &gt; Stage 3 &gt;&#xD;
1) Increase in serum creatinine to ≥300% (&gt;3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR&#xD;
Urine output &lt;0.3 ml/kg/h for ≥24 h OR&#xD;
&gt;&#xD;
Anuria for ≥12 h</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Fatal bleeding (BARC type 5) OR&#xD;
&gt;&#xD;
Bleeding in a critical organs, such as intracranial, intraspinal,&#xD;
&gt; intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR&#xD;
&gt;&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR&#xD;
&gt;&#xD;
Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* &gt; (BARC type 3b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days</measure>
    <time_frame>Assessed at 30 days</time_frame>
    <description>Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Resheath and Recapture Success Rate</measure>
    <time_frame>Assessed intra-procedurally</time_frame>
    <description>Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Performance -Mean Gradient</measure>
    <time_frame>Assessed at baseline, 30 days, 6 months, and 1 year</time_frame>
    <description>Mean gradient by Doppler echocardiography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Vascular Complication</measure>
    <time_frame>Assessed at 30 days post-implantation</time_frame>
    <description>Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR&#xD;
&gt;&#xD;
Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR&#xD;
&gt;&#xD;
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR&#xD;
&gt;&#xD;
The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR&#xD;
&gt;&#xD;
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR&#xD;
&gt;&#xD;
Surgery for access site nerve injury OR&#xD;
&gt;&#xD;
Permanent access related nerve injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Performance - Aortic Valve Area</measure>
    <time_frame>Assessed at baseline, 30 days, 6 months, and 1 year</time_frame>
    <description>Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe</measure>
    <time_frame>Assessed at 30 days, 6 months, and 1 year</time_frame>
    <description>Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">241</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>CoreValve Evolut R TAVR system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
EnVeo R Loading System (LS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CoreValve Evolut R TAVR system</intervention_name>
    <arm_group_label>CoreValve Evolut R TAVR system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria - Severe aortic stenosis, defined as aortic valve area of &lt; 1.0 cm2 (or&#xD;
        aortic valve area index of &lt; 0.6 cm2/m2) by the continuity equation, AND mean gradient &gt; 40&#xD;
        mmHg or maximal aortic valve velocity &gt; 4.0 m/sec by resting echocardiogram.&#xD;
&#xD;
        Subjects with low-flow/low gradient severe aortic stenosis can be included, provided&#xD;
        low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of &gt;40&#xD;
        mmHg or a maximal aortic valve velocity of &gt;4.0 m/sec, AND aortic valve area of &lt;1.0cm2 (or&#xD;
        aortic valve area index of &lt;0.6 cm2/m2).&#xD;
&#xD;
          -  STS score of ≥ 8 OR documented heart team agreement of ≥ high risk for AVR due to&#xD;
             frailty or co-morbidities.&#xD;
&#xD;
          -  Symptoms of aortic stenosis, AND NYHA Functional Class II or greater&#xD;
&#xD;
          -  The subject and the treating physician agree that the subject will return for all&#xD;
             required post-procedure follow-up visits.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Any condition considered a contraindication for placement of a bioprosthetic valve&#xD;
             (e.g. subject is indicated for mechanical prosthetic valve).&#xD;
&#xD;
          -  A known hypersensitivity or contraindication to any of the following which cannot be&#xD;
             adequately pre-medicated: aspirin or heparin (HIT/HITTS) and bivalirudin, ticlopidine&#xD;
             and clopidogrel, Nitinol (titanium or nickel), contrast media&#xD;
&#xD;
          -  Blood dyscrasias as defined: leukopenia (WBC &lt; 1000 mm3), thrombocytopenia (platelet&#xD;
             count &lt;50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or&#xD;
             hypercoagulable states.&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization.&#xD;
&#xD;
          -  Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) &lt;&#xD;
             20% by echocardiography, contrast ventriculography, or radionuclide ventriculography.&#xD;
&#xD;
          -  End stage renal disease requiring chronic dialysis or creatinine clearance &lt; 20&#xD;
             cc/min.&#xD;
&#xD;
          -  Ongoing sepsis, including active endocarditis.&#xD;
&#xD;
          -  Any percutaneous coronary or peripheral interventional procedure with a bare metal or&#xD;
             drug eluting stent performed within 30 days prior to the study procedure.&#xD;
&#xD;
          -  Symptomatic carotid or vertebral artery disease or successful treatment of carotid&#xD;
             stenosis within 10 weeks of Heart Team assessment.&#xD;
&#xD;
          -  Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or&#xD;
             mechanical hemodynamic support.&#xD;
&#xD;
          -  Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or&#xD;
             transient ischemic attack (TIA).&#xD;
&#xD;
          -  Gastrointestinal (GI) bleeding that would preclude anticoagulation.&#xD;
&#xD;
          -  Subject refuses a blood transfusion.&#xD;
&#xD;
          -  Severe dementia (resulting in either inability to provide informed consent for the&#xD;
             study/procedure, prevents independent lifestyle outside of a chronic care facility, or&#xD;
             will fundamentally complicate rehabilitation from the procedure or compliance with&#xD;
             follow-up visits).&#xD;
&#xD;
          -  Estimated life expectancy of less than 12 months due to associated non-cardiac&#xD;
             co-morbid conditions.&#xD;
&#xD;
          -  Other medical, social, or psychological conditions that in the opinion of the&#xD;
             investigator precludes the subject from appropriate consent or adherence to the&#xD;
             protocol required follow-ups exams.&#xD;
&#xD;
          -  Currently participating in an investigational drug or another device study (excluding&#xD;
             registries).&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction ≤ 30 days before the study procedure.&#xD;
&#xD;
          -  Need for emergency surgery for any reason.&#xD;
&#xD;
          -  Liver failure (Child-Pugh class C).&#xD;
&#xD;
          -  Subject is pregnant or breast feeding.&#xD;
&#xD;
        Anatomical exclusion criteria:&#xD;
&#xD;
          -  Pre-existing prosthetic heart valve in any position.&#xD;
&#xD;
          -  Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation).&#xD;
&#xD;
          -  Severe mitral regurgitation.&#xD;
&#xD;
          -  Severe tricuspid regurgitation.&#xD;
&#xD;
          -  Moderate or severe mitral stenosis.&#xD;
&#xD;
          -  Hypertrophic obstructive cardiomyopathy.&#xD;
&#xD;
          -  Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac&#xD;
             mass, thrombus, or vegetation.&#xD;
&#xD;
          -  Congenital bicuspid or unicuspid valve verified by echocardiography.&#xD;
&#xD;
        For transfemoral or transaxillary (subclavian) acess:&#xD;
&#xD;
        - Access vessel diameter &lt;5.0mm or &lt;6.0mm for patent LIMA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathew R Williams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New York Langone Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Good Samaritan Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center/Medstar</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Heart Center of Indiana/The Care Group, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconcess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Health Systems</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Detroit Medical Center Cardiovascular Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Memorial Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Hospital</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Methodist Hospital/Ohio Health Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburg Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinnacle Health</name>
      <address>
        <city>Wormleysburg</city>
        <state>Pennsylvania</state>
        <zip>17043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Heart and Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist DeBakey Heart &amp; Vasc Ctr/The Methodist Hosp</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Health Care/St Luke's Medical Center</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>September 30, 2016</results_first_submitted>
  <results_first_submitted_qc>November 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2017</results_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</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>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CoreValve Evolut R TAVR System</title>
          <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Implant</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="241">241 Attempted Implant</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="241">237 Implanted</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>1-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="241">241 Attempted Implant</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject anesthetized but product not onsite, for medical justification treated w/commercial device</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="232"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="222"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="213"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>24-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="171"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>36-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="171"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>48-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>60-Month</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>pt 103 years old no longer traveling for MD visits</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Covid-19 pt not willing to be seen</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>241 attempted implant</population>
      <group_list>
        <group group_id="B1">
          <title>CoreValve Evolut R TAVR System</title>
          <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&gt;&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&gt;&#xD;
EnVeo R Loading System (LS)&gt; &gt; CoreValve Evolut R TAVR system</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="241"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.3" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>All-cause Mortality at 30 Days by Percent</title>
        <description>Percentage of patients that died by any cause at 30 days</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality at 30 Days by Percent</title>
          <description>Percentage of patients that died by any cause at 30 days</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of partcipants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.1" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Disabling Stroke at 30 Days</title>
        <description>Stroke Diagnostic Criteria:&#xD;
&gt;&#xD;
Acute episode of focal or global neurological deficit with at least 2 of the following:&#xD;
change in level of consciousness &gt;&#xD;
hemiplegia, hemiparesis&#xD;
numbness or sensory loss affecting 1 side &gt;&#xD;
dysphasia or aphasia&#xD;
hemianopia&#xD;
amaurosis fugax &gt;&#xD;
other neurological signs or symptoms consistent with stroke&#xD;
2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist&#xD;
3.) Confirmation of the diagnosis by at least 1 of the following:&#xD;
Neurological specialist &gt;&#xD;
Neuroimaging procedure, or on clincial grounds alone &gt; Stroke: durations of neural deficit &gt; 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death&#xD;
Defined by VARC II:&#xD;
&gt; An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Disabling Stroke at 30 Days</title>
          <description>Stroke Diagnostic Criteria:&#xD;
&gt;&#xD;
Acute episode of focal or global neurological deficit with at least 2 of the following:&#xD;
change in level of consciousness &gt;&#xD;
hemiplegia, hemiparesis&#xD;
numbness or sensory loss affecting 1 side &gt;&#xD;
dysphasia or aphasia&#xD;
hemianopia&#xD;
amaurosis fugax &gt;&#xD;
other neurological signs or symptoms consistent with stroke&#xD;
2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist&#xD;
3.) Confirmation of the diagnosis by at least 1 of the following:&#xD;
Neurological specialist &gt;&#xD;
Neuroimaging procedure, or on clincial grounds alone &gt; Stroke: durations of neural deficit &gt; 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death&#xD;
Defined by VARC II:&#xD;
&gt; An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.7" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Device Success Rate Between 24 and 7 Day</title>
        <description>Percentage of patients with Device Success defined as:&#xD;
Absence of procedural mortality, AND&#xD;
Correct positioning of a single Evolut R valve into the proper anatomical location, AND&#xD;
Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity &lt; 3m/sec, AND&#xD;
Absence of moderate or severe prosthetic valve regurgitation</description>
        <time_frame>Assessed at 24 hours to seven days post implantation</time_frame>
        <population>All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Device Success Rate Between 24 and 7 Day</title>
          <description>Percentage of patients with Device Success defined as:&#xD;
Absence of procedural mortality, AND&#xD;
Correct positioning of a single Evolut R valve into the proper anatomical location, AND&#xD;
Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity &lt; 3m/sec, AND&#xD;
Absence of moderate or severe prosthetic valve regurgitation</description>
          <population>All subjects implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system</population>
          <units>percentage of overall device success</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2" lower_limit="62.3" upper_limit="75.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)</title>
        <description>Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.</description>
        <time_frame>Assessed at 24 hours to 7 days post implantation</time_frame>
        <population>Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)</title>
          <description>Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.</description>
          <population>Subset includes all subjects who are implanted with the Evolut R TAV, defined as the Evolut R TAV is placed in the aortic annulus and completely released from the Enveo catheter delivery system</population>
          <units>percentage of partcipants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.5" lower_limit="93.3" upper_limit="98.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)</title>
        <description>Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)</title>
          <description>Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.</description>
          <population>The safety subset includes all subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, or any monitoring line placed.</population>
          <units>percentage of overall patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coronary Artery Obstruction Requiring Intervention.</title>
        <description>Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Coronary Artery Obstruction Requiring Intervention.</title>
          <description>Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.1" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent VARC II Combined Safety Endpoint at 30 Days</title>
        <description>VARC II composite safety endpoint rate includes percent freedom from the following components:&#xD;
All-cause mortality&#xD;
All stroke (disabling and non-disabling)&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury: stage 2 or 3 (including renal replacement therapy).&#xD;
Coronary artery obstruction requiring intervention.&#xD;
Major vascular complication.&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percent VARC II Combined Safety Endpoint at 30 Days</title>
          <description>VARC II composite safety endpoint rate includes percent freedom from the following components:&#xD;
All-cause mortality&#xD;
All stroke (disabling and non-disabling)&#xD;
Life-threatening bleeding&#xD;
Acute kidney injury: stage 2 or 3 (including renal replacement therapy).&#xD;
Coronary artery obstruction requiring intervention.&#xD;
Major vascular complication.&#xD;
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="10.6" upper_limit="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).</title>
        <description>Stage 2&#xD;
Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR&#xD;
&gt;&#xD;
Urine output &lt;0.5 mL/kg/h for &gt;12 but &lt;24 h &gt; Stage 3 &gt;&#xD;
1) Increase in serum creatinine to ≥300% (&gt;3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR&#xD;
Urine output &lt;0.3 ml/kg/h for ≥24 h OR&#xD;
&gt;&#xD;
Anuria for ≥12 h</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).</title>
          <description>Stage 2&#xD;
Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR&#xD;
&gt;&#xD;
Urine output &lt;0.5 mL/kg/h for &gt;12 but &lt;24 h &gt; Stage 3 &gt;&#xD;
1) Increase in serum creatinine to ≥300% (&gt;3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR&#xD;
Urine output &lt;0.3 ml/kg/h for ≥24 h OR&#xD;
&gt;&#xD;
Anuria for ≥12 h</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.4" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate</title>
        <description>Fatal bleeding (BARC type 5) OR&#xD;
&gt;&#xD;
Bleeding in a critical organs, such as intracranial, intraspinal,&#xD;
&gt; intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR&#xD;
&gt;&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR&#xD;
&gt;&#xD;
Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* &gt; (BARC type 3b)</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate</title>
          <description>Fatal bleeding (BARC type 5) OR&#xD;
&gt;&#xD;
Bleeding in a critical organs, such as intracranial, intraspinal,&#xD;
&gt; intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR&#xD;
&gt;&#xD;
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR&#xD;
&gt;&#xD;
Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* &gt; (BARC type 3b)</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="4.4" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days</title>
        <description>Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure</description>
        <time_frame>Assessed at 30 days</time_frame>
        <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days</title>
          <description>Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure</description>
          <population>All subjects who are brought into the procedure room and any of the following have occurred: anesthesia administered, vascular line placed, TEE placed, or any monitoring line placed. Additionally, these patients did NOT have ICD or PPM at the time of the index procedure.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.7" lower_limit="14.7" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Resheath and Recapture Success Rate</title>
        <description>Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.</description>
        <time_frame>Assessed intra-procedurally</time_frame>
        <population>65 patients had resheath or recapture feature used during the 241 attempted procedures.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Resheath and Recapture Success Rate</title>
          <description>Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.</description>
          <population>65 patients had resheath or recapture feature used during the 241 attempted procedures.</population>
          <units>percentage of resheath or recapture</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Performance -Mean Gradient</title>
        <description>Mean gradient by Doppler echocardiography.</description>
        <time_frame>Assessed at baseline, 30 days, 6 months, and 1 year</time_frame>
        <population>The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Performance -Mean Gradient</title>
          <description>Mean gradient by Doppler echocardiography.</description>
          <population>The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system. Only subjects with echo can be analyzed.</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="237"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" spread="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="228"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Vascular Complication</title>
        <description>Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR&#xD;
&gt;&#xD;
Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR&#xD;
&gt;&#xD;
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR&#xD;
&gt;&#xD;
The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR&#xD;
&gt;&#xD;
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR&#xD;
&gt;&#xD;
Surgery for access site nerve injury OR&#xD;
&gt;&#xD;
Permanent access related nerve injury</description>
        <time_frame>Assessed at 30 days post-implantation</time_frame>
        <population>The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Major Vascular Complication</title>
          <description>Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR&#xD;
&gt;&#xD;
Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR&#xD;
&gt;&#xD;
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR&#xD;
&gt;&#xD;
The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR&#xD;
&gt;&#xD;
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR&#xD;
&gt;&#xD;
Surgery for access site nerve injury OR&#xD;
&gt;&#xD;
Permanent access related nerve injury</description>
          <population>The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the Evolut R system.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="4.8" upper_limit="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Performance - Aortic Valve Area</title>
        <description>Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2</description>
        <time_frame>Assessed at baseline, 30 days, 6 months, and 1 year</time_frame>
        <population>The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Performance - Aortic Valve Area</title>
          <description>Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2</description>
          <population>The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation - only subjects with echo can be analyzed.</population>
          <units>cm²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="211"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="204"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="180"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe</title>
        <description>Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.</description>
        <time_frame>Assessed at 30 days, 6 months, and 1 year</time_frame>
        <population>The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>CoreValve Evolut R TAVR System</title>
            <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV)&#xD;
&gt;&#xD;
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath&#xD;
&gt;&#xD;
EnVeo R Loading System (LS)&#xD;
&gt;&#xD;
&gt; CoreValve Evolut R TAVR system</description>
          </group>
        </group_list>
        <measure>
          <title>Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe</title>
          <description>Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.</description>
          <population>The hemodynamic performance subset includes all subjects implanted with the Evolut R TAV for more than 24 hours post implantation. Only subjects with echo can be analyzed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="237"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 days</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="227"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="205"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 year</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="191"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All events - 12 months, All Cause Mortality - 60 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CoreValve Evolut R TAVR System</title>
          <description>The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:&#xD;
Evolut R Transcatheter Aortic Valve (TAV) EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath EnVeo R Loading System (LS)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 10.0</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="107" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="170" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="39" subjects_affected="36" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Haemolytic Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Iron Deficiency Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Splenic Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="16" subjects_affected="15" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" events="32" subjects_affected="32" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Second Degree</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Left</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Right</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="28" subjects_affected="22" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Perforation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiogenic Shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Intracardiac Thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Left Ventricular Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Mitral Valve Incompetence</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Nodal Rhythm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pericardial Effusion</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pulseless Electrical Activity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Right Ventricular Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Right Ventricular Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Sinus Node Dysfunction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Stress Cardiomyopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Ventricular Asystole</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Ventricular Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Visual Impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gastric Ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hiatus Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Intestinal Ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Retroperitoneal Haemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Device Deployment Issue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Device Dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Implant Site Haemorrhage</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Implant Site Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Lead Dislodgement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Systemic Inflammatory Response Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gallbladder Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Wall Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Acquired Immunodeficiency Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Colitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Diverticulitis Intestinal Haemorrhagic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Incision Site Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pneumonia Staphylococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Arterial Injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Compression Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Feeding Tube Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Incision Site Complication</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Incision Site Haematoma</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Incision Site Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Vascular Pseudoaneurysm</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Magnesium Decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>International Normalised Ratio Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Urine Output Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Lactic Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Metabolic Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Spinal Column Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Chondrosarcoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Colon Neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Small Intestine Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypoxic-Ischaemic Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Ischaemic Stroke</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Partial Seizures</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Speech Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Thalamic Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hallucination, Visual</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Mental Disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Renal Infarct</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Acute Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pneumonia Aspiration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pulmonary Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Respiratory Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Stridor</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Subacute Cutaneous Lupus Erythematosus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalisation</sub_title>
                <counts group_id="E1" events="18" subjects_affected="1" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Aortic Dissection Rupture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Femoral Artery Dissection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Femoral Artery Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Iliac Vein Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Intermittent Claudication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Labile Blood Pressure</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Labile Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Malignant Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Orthostatic Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Peripheral Ischaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Peripheral Vascular Disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 10.0</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="197" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="49" subjects_affected="48" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="37" subjects_affected="37" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block First Degree</sub_title>
                <counts group_id="E1" events="40" subjects_affected="39" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Left</sub_title>
                <counts group_id="E1" events="82" subjects_affected="79" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Bundle Branch Block Right</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="241"/>
              </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="38" subjects_affected="32" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="25" subjects_affected="18" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Incision Site Haematoma</sub_title>
                <counts group_id="E1" events="18" subjects_affected="16" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="14" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="241"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="44" subjects_affected="40" subjects_at_risk="241"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="21" subjects_affected="20" subjects_at_risk="241"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kristin Smith</name_or_title>
      <organization>Medtronic</organization>
      <phone>763-526-3095</phone>
      <email>kristin.m.smith@medtronic.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/NCT02207569
org study id: 10126779DOC
nct id: NCT02207569
lead sponsor: 
has dmc: Yes
The study objectives are to assess the safety and efficacy of the CoreValve Evolut R
      transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic
      aortic stenosis are considered at high or extreme risk for surgical aortic valve replacement.
This objective will be accomplished by a prospective, single arm, historical controlled,
      multi-site study involving a minimum of 150 implanted subjects with no more than 250
      implanted subjects at up to 25 study sites in the United States. Procedural and 30 day safety
      and efficacy results from this study will be compared to appropriate historical control data
      for the Medtronic CoreValve System. Subjects will be followed up to 5 years following
      implantation.

      The enrollment phase of the study is estimated to take approximately 6-9 months. As each
      implanted subject is to be followed up to 5 years, the estimated study duration is
      approximately 66-69 months, excluding the time required for preparing the final report.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause Mortality at 30 Days by Percent
time frame: Assessed at 30 days post-implantation
description: Percentage of patients that died by any cause at 30 days
measure: Percentage of Patients With Disabling Stroke at 30 Days
time frame: Assessed at 30 days post-implantation
description: Stroke Diagnostic Criteria:
>
Acute episode of focal or global neurological deficit with at least 2 of the following:
change in level of consciousness >
hemiplegia, hemiparesis
numbness or sensory loss affecting 1 side >
dysphasia or aphasia
hemianopia
amaurosis fugax >
other neurological signs or symptoms consistent with stroke
2.) No other readily identifiable non-stroke cause or the clinical presentation, to be determined by or in conjunctions with the designated neurologist
3.) Confirmation of the diagnosis by at least 1 of the following:
Neurological specialist >
Neuroimaging procedure, or on clincial grounds alone > Stroke: durations of neural deficit > 24 h if available neuroimaging documents a new hemofrrhage or infarct; or the neurological deficit results in death
Defined by VARC II:
> An mRS (Modified Rankin Score) of 2 or more at 90 days and an increase in at least 1 mRS category from pre-stroke baseline
measure: Percent Device Success Rate Between 24 and 7 Day
time frame: Assessed at 24 hours to seven days post implantation
description: Percentage of patients with Device Success defined as:
Absence of procedural mortality, AND
Correct positioning of a single Evolut R valve into the proper anatomical location, AND
Absence of patient-prosthesis mismatch, and mean gradient , 20 mm Hg (or peak velocity < 3m/sec, AND
Absence of moderate or severe prosthetic valve regurgitation
measure: Percentage of Patients With Less Than Moderate Prosthetic Regurgitation at Early Post Procedure Echocardiogram (24 Hours to 7 Days)
time frame: Assessed at 24 hours to 7 days post implantation
description: Percentage of patience with none, trace or mild total prosthetic regurgitation at early post procedure echo cardiogram (24 hours to 7 days) as evaluated by echo core lab.
measure: Individual Component of VARC II Safety Endpoint: Percentage of People Requiring Valve-related Dysfunction Requiring Repeat Procedure (BAV, TAVI, or SAVR)
time frame: Assessed at 30 days post-implantation
description: Percentage of patients with any valve dysfunction that requires repeat procedure (e.g. balloon valvuloplasty, TAVI, or surgical AVR), per VARC II definition.
measure: Coronary Artery Obstruction Requiring Intervention.
time frame: Assessed at 30 days post-implantation
description: Angiographic or echocardiographic evidence of a new, partial or complete, obstruction of a coronary ostium, either by the Evolut R prosthesis itself, the native leaflets, calcifications, or dissection, occurring during or after the TAVI procedure.
measure: Percent VARC II Combined Safety Endpoint at 30 Days
time frame: Assessed at 30 days post-implantation
description: VARC II composite safety endpoint rate includes percent freedom from the following components:
All-cause mortality
All stroke (disabling and non-disabling)
Life-threatening bleeding
Acute kidney injury: stage 2 or 3 (including renal replacement therapy).
Coronary artery obstruction requiring intervention.
Major vascular complication.
Valve-related dysfunction requiring repeat procedure (BAV, TAVI, or SAVR)
measure: Percent of Patients With Acute Kidney Injury: Stage 2 or 3 (Including Renal Replacement Therapy).
time frame: Assessed at 30 days post-implantation
description: Stage 2
Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR
>
Urine output <0.5 mL/kg/h for >12 but <24 h > Stage 3 >
1) Increase in serum creatinine to ≥300% (>3 x increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR
Urine output <0.3 ml/kg/h for ≥24 h OR
>
Anuria for ≥12 h
measure: Percentage of Patients With Life-threatening or Disabling Bleeding Event Rate
time frame: Assessed at 30 days post-implantation
description: Fatal bleeding (BARC type 5) OR
>
Bleeding in a critical organs, such as intracranial, intraspinal,
> intraocular, or pericardial necessitating pericardiocentesis, or intramuscular with compartment syndrome (BARC type 3b and 3c) OR
>
Bleeding causing hypovolemic shock or severe hypotension requiring vasopressors or surgery (BARC type 3b) OR
>
Overt source of bleeding with drop in hemoglobin ≥5 g/dL or whole blood or packed red blood cells (RBCs) transfusion ≥4 units* > (BARC type 3b)
measure: Percent Rate of Patients Who Received New Permanent Pacemaker Implant at 30 Days
time frame: Assessed at 30 days
description: Percent of patients who underwent implantation of new permanent pacemaker or ICD during or after index procedure
measure: Percent Resheath and Recapture Success Rate
time frame: Assessed intra-procedurally
description: Resheath or recapture success rate (where attempted) where a successful resheath is defined as the intended portion of the Evolut R is resheathed into the capsule of the delivery catheter to the intended amount, as verified by flouroscopy; and a successful recapture is defined as the entire Evolut R TAV (including the frame) is full resheathed into the capsule of the delivery catheter until there is no gap between the capsule and the tip , as verified by flouroscopy. Resheath or recapture wa attempted in a subset of patients. Success rate is calculated as successful resheath or recaputure events in the number of total events. Resheath anad recapture is only possible during the index procedure.
measure: Hemodynamic Performance -Mean Gradient
time frame: Assessed at baseline, 30 days, 6 months, and 1 year
description: Mean gradient by Doppler echocardiography.
measure: Major Vascular Complication
time frame: Assessed at 30 days post-implantation
description: Any aortic dissection, aortic rupture, annulus rupture, left ventricle perforation, or new apical aneurysm/pseudoaneurysm OR
>
Access-related vascular injury (dissection, stenosis, perforation, rupture, arterio-venous fistula, pseudoaneurysm, hematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure) leading to death, life-threatening or major bleeding, visceral ischemia, or neurological impairment OR
>
Distal embolization (noncerebral) from a vascular source requiring surgery or resulting in amputation or irreversible end-organ damage OR
>
The use of unplanned endovascular or surgery associated with death, major bleeding, visceral ischemia or neurological impairment OR
>
Any new ipsilateral lower extremity ischemia documented by patient symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram OR
>
Surgery for access site nerve injury OR
>
Permanent access related nerve injury
measure: Hemodynamic Performance - Aortic Valve Area
time frame: Assessed at baseline, 30 days, 6 months, and 1 year
description: Hemodynamic performance by Doppler echocardiography - Aortic Valve Area cm2
measure: Hemodynamic Performance: Total Prosthetic Valve Regurgitation Graded as Moderate or Severe
time frame: Assessed at 30 days, 6 months, and 1 year
description: Hemodynamic performance: the percent of patients who have a degree of total prosthetic valve regurgitation that is moderate or severe.
arm group label: CoreValve Evolut R TAVR system
arm group type: Experimental
description: The CoreValve Evolut R System is a transcatheter aortic valve implantation system comprised of the following three components:
Evolut R Transcatheter Aortic Valve (TAV)
EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
EnVeo R Loading System (LS)
intervention type: Device
intervention name: CoreValve Evolut R TAVR system
arm group label: CoreValve Evolut R TAVR system
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mathew R Williams, MD
role: Principal Investigator
affiliation: New York Langone Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 