<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/NCT02214277</url>
  </required_header>
  <id_info>
    <org_study_id>CP-10836</org_study_id>
    <nct_id>NCT02214277</nct_id>
  </id_info>
  <brief_title>Cerebral Protection in Transcatheter Aortic Valve Replacement</brief_title>
  <official_title>Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claret Medical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Claret Medical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Sentinel System will be a safe and effective method for capturing and removing embolic&#xD;
      material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce&#xD;
      the ischemic burden in the cerebral anterior circulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and&#xD;
      retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation&#xD;
      while performing transcatheter aortic valve replacement.&#xD;
&#xD;
      The objective of this study is to assess the safety and efficacy of the Claret Medical&#xD;
      Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic&#xD;
      Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).&#xD;
&#xD;
      The study population is comprised of subjects with severe symptomatic calcified native aortic&#xD;
      valve stenosis who meet the commercially approved indications for TAVR with the Edwards&#xD;
      SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.</measure>
    <time_frame>Day 2-7 Post-Procedure</time_frame>
    <description>Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days</measure>
    <time_frame>30 Days Post-Procedure</time_frame>
    <description>Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Captured Debris Histopathology (Observational)</measure>
    <time_frame>Post-procedure</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">363</enrollment>
  <condition>Severe Symptomatic Calcified Native Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Test Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cerebral Protection System-The SENTINEL System with TAVR</intervention_name>
    <description>Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.</description>
    <arm_group_label>Safety Arm</arm_group_label>
    <arm_group_label>Test Arm</arm_group_label>
    <other_name>Cerebral Protection System: The SENTINEL System</other_name>
    <other_name>TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TAVR</intervention_name>
    <arm_group_label>Control Arm</arm_group_label>
    <other_name>TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Approved indications for commercially available Edwards SAPIEN Transcatheter Heart&#xD;
             Valve, model 9000TFX or SAPIEN XT, model 9300TFX meeting one of the three sub-criteria&#xD;
             below:&#xD;
&#xD;
             SAPIEN&#xD;
&#xD;
               1. transfemoral delivery in subjects with severe symptomatic calcified native aortic&#xD;
                  valve stenosis without severe aortic insufficiency and with ejection fraction&#xD;
                  &gt;20% who have been examined by a heart team including an experienced cardiac&#xD;
                  surgeon and a cardiologist and found to either be:&#xD;
&#xD;
                    1. inoperable and in whom existing co-morbidities would not preclude the&#xD;
                       expected benefit from correction of the aortic stenosis; or&#xD;
&#xD;
                    2. be operative candidates for aortic valve replacement but who have a Society&#xD;
                       of Thoracic Surgeons predicted operative risk score &gt;8% or are judged by the&#xD;
                       heart team to be at a 15% risk of mortality for surgical aortic valve&#xD;
                       replacement.&#xD;
&#xD;
                  or&#xD;
&#xD;
               2. transapical delivery in subjects with severe symptomatic calcified native aortic&#xD;
                  valve stenosis without severe aortic insufficiency and with ejection fraction &gt;&#xD;
                  20% who have been examined by a heart team including an experienced cardiac&#xD;
                  surgeon and a cardiologist and found to be operative candidates for aortic valve&#xD;
                  replacement but who have a Society of Thoracic Surgeons operative risk score 8%&#xD;
                  or are judged by the heart team to be at a 15% risk of mortality for surgical&#xD;
                  aortic valve replacement.&#xD;
&#xD;
                  SAPIEN XT (Transfemoral or Transapical only)&#xD;
&#xD;
               3. in patients with symptomatic heart disease due to severe native calcific aortic&#xD;
                  stenosis (aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2, a&#xD;
                  mean aortic valve gradient of ≥ 40 mmHg, or a peak aortic-jet velocity of ≥ 4.0&#xD;
                  m/s), and with native anatomy appropriate for the 23, 26, or 29 mm valve system,&#xD;
                  who are judged by a heart team, including a cardiac surgeon, to be at high or&#xD;
                  greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons&#xD;
                  operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).&#xD;
&#xD;
          2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15&#xD;
             mm) diameters without significant stenosis (&gt; 70%) as determined by Multi-Slice&#xD;
             Computed Tomography (MSCT) scan or equivalent imaging modality&#xD;
&#xD;
          3. The subject and the treating physician agree that the subject will return for all&#xD;
             required post-procedure follow-up visit&#xD;
&#xD;
          4. The subject or the subject's legal representative has been informed of the nature of&#xD;
             the trial, agrees to its provisions and has provided written informed consent as&#xD;
             approved by the IRB of the respective clinical site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General&#xD;
&#xD;
          1. Vasculature in the right extremity precluding 6Fr sheath radial or brachial access&#xD;
&#xD;
          2. Inadequate circulation to the right extremity as evidenced by signs of artery&#xD;
             occlusion (modified Allen's test) or absence of radial/brachial pulse&#xD;
&#xD;
          3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity&#xD;
             vasculature&#xD;
&#xD;
          4. Evidence of an acute myocardial infarction ≤ 1 month before the intended treatment&#xD;
&#xD;
          5. Aortic valve is a congenital unicuspid or bicuspid valve; or is non-calcified&#xD;
&#xD;
          6. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant&#xD;
             aortic regurgitation &gt;3+)&#xD;
&#xD;
          7. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is&#xD;
             performed within 30 days of the index procedure (unless part of planned strategy for&#xD;
             treatment of concomitant coronary artery disease)&#xD;
&#xD;
          8. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe&#xD;
             (greater than 3+) mitral insufficiency&#xD;
&#xD;
          9. Blood dyscrasias as defined: Leukopenia, acute anemia, thrombocytopenia, history of&#xD;
             bleeding diathesis or coagulopathy&#xD;
&#xD;
         10. Hemodynamic instability requiring inotropic support or mechanical heart assistance.&#xD;
&#xD;
         11. Need for emergency surgery for any reason&#xD;
&#xD;
         12. Hypertrophic cardiomyopathy with or without obstruction&#xD;
&#xD;
         13. Severe ventricular dysfunction with LVEF ≤20%&#xD;
&#xD;
         14. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation&#xD;
&#xD;
         15. Symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant&#xD;
             CEA/stenting&#xD;
&#xD;
         16. Subject has undergone carotid stenting or carotid endarterectomy within the previous 6&#xD;
             weeks&#xD;
&#xD;
         17. Active peptic ulcer or upper GI bleeding within the prior 3 months&#xD;
&#xD;
         18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, or&#xD;
             clopidogrel, or sensitivity to contrast media, which cannot be adequately&#xD;
             pre-medicated&#xD;
&#xD;
         19. Recent (within 6 months) CVA or a TIA&#xD;
&#xD;
         20. Renal insufficiency (creatinine &gt; 3.0 mg/dL or GFR &lt; 30) and/or renal replacement&#xD;
             therapy at the time of screening&#xD;
&#xD;
         21. Life expectancy &lt; 12 months due to non-cardiac co-morbid conditions&#xD;
&#xD;
         22. Subjects in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who&#xD;
             will refuse transfusion&#xD;
&#xD;
         23. Subjects who have active bacterial endocarditis or other active infections&#xD;
&#xD;
         24. Currently participating in an investigational drug or another device study&#xD;
&#xD;
         25. Subjects who have a planned treatment with any other investigational device or&#xD;
             procedure during the study follow-up period (90 days)&#xD;
&#xD;
         26. Subject with planned concomitant surgical or transcatheter ablation for Atrial&#xD;
             Fibrillation during the study follow-up period (90 days)&#xD;
&#xD;
         27. Any subject with a balloon valvuloplasty (BAV) within 30 days of the procedure&#xD;
&#xD;
             Neurologic&#xD;
&#xD;
         28. Subject had active major psychiatric disease&#xD;
&#xD;
         29. Subject has severe visual, auditory, or learning impairment and who are unable to&#xD;
             comprehend English and therefore unable to be consented for the study&#xD;
&#xD;
         30. Subjects with neurodegenerative or other progressive neurological disease or history&#xD;
             of significant head trauma followed by persistent neurologic defaults or known&#xD;
             structural brain abnormalities&#xD;
&#xD;
             Angiographic&#xD;
&#xD;
         31. Excessive tortuosity in the right radial/brachial/subclavian artery preventing&#xD;
             Sentinel System access and insertion&#xD;
&#xD;
         32. Subject whose brachiocephalic or left carotid artery reveals significant stenosis,&#xD;
             calcification, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the&#xD;
             ostium&#xD;
&#xD;
             Magnetic Resonance Imaging&#xD;
&#xD;
         33. Subject Body Mass Index (BMI) precluding imaging in scanner&#xD;
&#xD;
         34. Contraindications to MRI (subjects with any implantable temporary or permanent&#xD;
             pacemaker or defibrillator, metal implants in field of view, metallic fragments,&#xD;
             clips, or devices in the brain or eye before TAVR procedure)&#xD;
&#xD;
         35. Planned implantation of a pacemaker or defibrillator implantation after TAVR&#xD;
&#xD;
         36. Claustrophobia&#xD;
&#xD;
         37. Known allergy to gadolinium or contrast agent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susheel Kodali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samir Kapadia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Hospital</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Houston / Memorial Hermann</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UVA Advanced Cardiac Valve Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UW Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herzzentrum Leipzig - Universitatsklinik</name>
      <address>
        <city>Leipzig</city>
        <zip>04289</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/27815101</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.</citation>
    <PMID>27815101</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>September 1, 2017</results_first_submitted>
  <results_first_submitted_qc>April 10, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2018</results_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Embolic Protection</keyword>
  <keyword>Edwards SAPIEN THV</keyword>
  <keyword>Edwards SAPIEN XT</keyword>
  <keyword>TAVR</keyword>
  <keyword>Transfemoral</keyword>
  <keyword>Transapical</keyword>
  <keyword>Heart Valve Diseases</keyword>
  <keyword>Heart Diseases</keyword>
  <keyword>TAVI</keyword>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Aortic Valve</keyword>
  <keyword>Transcatheter Heart Valve</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Safety Arm</title>
          <description>Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure. Safety Arm patients did not receive MRI.&#xD;
The Safety Arm was combined with the Test Arm for analysis of safety endpoints.</description>
        </group>
        <group group_id="P2">
          <title>Test Arm</title>
          <description>Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.&#xD;
The Test Arm was compared to the Control Arm for analysis of MRI related endpoints, and was combined with the Safety Arm for analysis of safety endpoints.</description>
        </group>
        <group group_id="P3">
          <title>Control Arm</title>
          <description>Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.&#xD;
The Control Arm was compared to the Test arm for MRI related endpoints.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="121"/>
                <participants group_id="P3" count="119"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="104"/>
                <participants group_id="P2" count="96"/>
                <participants group_id="P3" count="85"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="34"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Safety Arm</title>
          <description>Safety Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study received safety follow-up at discharge, at 30 days and 90 days post-procedure; and neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure.</description>
        </group>
        <group group_id="B2">
          <title>Test Arm</title>
          <description>Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.</description>
        </group>
        <group group_id="B3">
          <title>Control Arm</title>
          <description>Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="123"/>
            <count group_id="B2" value="121"/>
            <count group_id="B3" value="119"/>
            <count group_id="B4" value="363"/>
          </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="81.5" spread="8.98"/>
                    <measurement group_id="B2" value="82.0" spread="7.95"/>
                    <measurement group_id="B3" value="83.4" spread="7.90"/>
                    <measurement group_id="B4" value="82.3" spread="8.31"/>
                  </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="68"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="58"/>
                    <measurement group_id="B4" value="189"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="61"/>
                    <measurement group_id="B4" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="118"/>
                    <measurement group_id="B4" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="115"/>
                    <measurement group_id="B3" value="115"/>
                    <measurement group_id="B4" value="339"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                  </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="98"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="289"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>STS PROM Score</title>
          <description>The Society of Thoracic Surgeons' (STS) predicted risk of mortality (PROM) score is used to predict the risk of operative mortality and morbidity of surgery. It is based on patient demographic and clinical variables, and scores are divided into four categories: low risk (&lt;4%),intermediate risk (&gt;=4% to &lt;8%), high risk (&gt;=8% to &lt;12%) ,very high risk (&gt;=12%).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.2" spread="3.17"/>
                    <measurement group_id="B2" value="6.4" spread="3.28"/>
                    <measurement group_id="B3" value="7.5" spread="4.66"/>
                    <measurement group_id="B4" value="6.7" spread="3.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Atrial Fibrillation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.</title>
        <description>Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.</description>
        <time_frame>Day 2-7 Post-Procedure</time_frame>
        <population>ITT with Imputation. Test Arm compared to the Control Arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Arm</title>
            <description>Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety followup at discharge, at 30 and at 90 days postprocedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days postprocedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days postprocedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days post-procedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days post-procedure; and Quality of Life assessment at baseline, 30 days and 90 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.</title>
          <description>Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.</description>
          <population>ITT with Imputation. Test Arm compared to the Control Arm.</population>
          <units>mm3</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.1" lower_limit="36.9" upper_limit="379.7"/>
                    <measurement group_id="O2" value="174" lower_limit="39.6" upper_limit="469.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days</title>
        <description>Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.</description>
        <time_frame>30 Days Post-Procedure</time_frame>
        <population>Safety Arm and Test Arm. ITT with imputation.</population>
        <group_list>
          <group group_id="O1">
            <title>Safety Cohort</title>
            <description>The Safety Cohort is the combination of the Safety and Test Arms.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days</title>
          <description>Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.</description>
          <population>Safety Arm and Test Arm. ITT with imputation.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="244"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Captured Debris Histopathology (Observational)</title>
        <time_frame>Post-procedure</time_frame>
        <population>Only Test Arm patients had debris samples collected. Only samples with evaluable filters were used in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Arm</title>
            <description>Test Arm patients received TAVR and the Sentinel System. Patients enrolled in this arm of the study underwent safety followup at discharge, at 30 and at 90 days postprocedure; MRI assessment for efficacy at baseline, 2-7 days and 30 days postprocedure; neurological evaluation at baseline, discharge, 30 days and 90 days (only in the case of a stroke ≤ 30 days) post procedure; neurocognitive evaluation at baseline, 2-7 days (optional), 30 days and 90 days postprocedure; Quality of Life assessment at baseline, 30 days and 90 days; and histopathological evaluation of debris captured in the Sentinel device filters.</description>
          </group>
        </group_list>
        <measure>
          <title>Captured Debris Histopathology (Observational)</title>
          <population>Only Test Arm patients had debris samples collected. Only samples with evaluable filters were used in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Debris present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No debris present</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>0-30 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Safety Cohort (Test + Safety Arms)</title>
          <description>The Safety Cohort is the combination of the Safety and Test Arms. Patients enrolled in these arms of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Control Arm patients received TAVR only. Patients enrolled in this arm of the study underwent safety follow-up at discharge, at 30 and at 90 days post-procedure.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="244"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="244"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="244"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="244"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="119"/>
              </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="1" subjects_affected="1" subjects_at_risk="244"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="158" subjects_at_risk="244"/>
                <counts group_id="E2" subjects_affected="79" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="23" subjects_at_risk="244"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="244"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Cardiac Arrest</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="244"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Conduction System Injury</sub_title>
                <counts group_id="E1" events="47" subjects_affected="42" subjects_at_risk="244"/>
                <counts group_id="E2" events="36" subjects_affected="30" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal Lab Value</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="244"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Bleed, Operative or Post-Operative</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="244"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="244"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="244"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="119"/>
              </event>
              <event>
                <sub_title>Other</sub_title>
                <counts group_id="E1" events="74" subjects_affected="53" subjects_at_risk="244"/>
                <counts group_id="E2" events="42" subjects_affected="30" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Access Site Hematoma</sub_title>
                <description>All vascular access sites , including Sentinel (radial, brachial) and TAVR access</description>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="244"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="119"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological Event, Imaging Only</sub_title>
                <counts group_id="E1" events="31" subjects_affected="30" subjects_at_risk="244"/>
                <counts group_id="E2" events="24" subjects_affected="23" subjects_at_risk="119"/>
              </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>Director of Clinical Research</name_or_title>
      <organization>Claret Medical</organization>
      <phone>707-528-9300</phone>
      <email>info@claretmedical.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/NCT02214277
org study id: CP-10836
nct id: NCT02214277
lead sponsor: 
has dmc: Yes
The Sentinel System will be a safe and effective method for capturing and removing embolic
      material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce
      the ischemic burden in the cerebral anterior circulation.
The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and
      retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation
      while performing transcatheter aortic valve replacement.

      The objective of this study is to assess the safety and efficacy of the Claret Medical
      Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic
      Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection).

      The study population is comprised of subjects with severe symptomatic calcified native aortic
      valve stenosis who meet the commercially approved indications for TAVR with the Edwards
      SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Reduction in Median Total New Lesion Volume in Protected Territories Between Test and Control Arms as Assessed by DW-MRI at Day 2-7 Post-procedure.
time frame: Day 2-7 Post-Procedure
description: Total new lesion volume is defined as the sum of all diffusion-positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. Protected territories are defined as brain territories uniquely perfused by the vessels protected by the Sentinel System, namely the left and right carotid arteries, and the right vertebral artery.
measure: Patients With Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
time frame: 30 Days Post-Procedure
description: Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3 within 72 hours or discharge, whatever occurs first) at 30 days compared to a historical performance goal of 18.3%.
measure: Captured Debris Histopathology (Observational)
time frame: Post-procedure
arm group label: Test Arm
arm group type: Experimental
arm group label: Control Arm
arm group type: Active Comparator
arm group label: Safety Arm
arm group type: Other
intervention type: Device
intervention name: Cerebral Protection System-The SENTINEL System with TAVR
description: Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
arm group label: Safety Arm
arm group label: Test Arm
other name: Cerebral Protection System: The SENTINEL System
other name: TAVR Device: Edwards SAPIEN THV or Edwards SAPIEN XT
intervention type: Device
intervention name: TAVR
arm group label: Control Arm
other name: TAVR: Edwards SAPIEN THV or Edwards SAPIEN XT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susheel Kodali, MD
role: Principal Investigator
affiliation: Columbia University
last name: Samir Kapadia, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/27815101
description: Related Info
citation: Kapadia SR, Kodali S, Makkar R, Mehran R, Lazar RM, Zivadinov R, Dwyer MG, Jilaihawi H, Virmani R, Anwaruddin S, Thourani VH, Nazif T, Mangner N, Woitek F, Krishnaswamy A, Mick S, Chakravarty T, Nakamura M, McCabe JM, Satler L, Zajarias A, Szeto WY, Svensson L, Alu MC, White RM, Kraemer C, Parhizgar A, Leon MB, Linke A; SENTINEL Trial Investigators. Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2017 Jan 31;69(4):367-377. doi: 10.1016/j.jacc.2016.10.023. Epub 2016 Nov 1.
PMID: 27815101
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
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