<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/NCT01735513</url>
  </required_header>
  <id_info>
    <org_study_id>WDHZ-TC-TAo-EmbolX</org_study_id>
    <nct_id>NCT01735513</nct_id>
  </id_info>
  <brief_title>Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation</brief_title>
  <acronym>TAo-EmbolX</acronym>
  <official_title>Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation: a Randomized-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve&#xD;
      implantation by the use of an embolic protection device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging</measure>
    <time_frame>Postoperative day 1-3</time_frame>
    <description>MRI of the brain is obtained at the same time as clinical exams. Scans are performed on a 1.5-T MR unit and a circular polarized head coil. The imaging protocol includes a transversal DW, single shot echo-planar sequence of the whole brain. Diffusion images are processed to generate isotopic apparent diffusion coefficient maps using dedicated software allowing for proper classification of the lesions. Transversal fluid-attenuated inversion recovery and transversal T2-weighted turbo spin-echo sequences are also performed. Slice thickness is 5mm for all sequences. Scans are read by an experienced neuroradiologist blinded to the clinical data. The presence, number, volume and location of all new focal diffusion abnormalities were recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment</measure>
    <time_frame>30 days after treatment</time_frame>
    <description>Stroke and transient ischaemic attack is defined according to the Valve Academic Research Consortium (VARC) recommendation. In case of stroke, the modified Rankin scale (mRS) is assessed to categorize the patient's level of functional independence during daily activities.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Neurocognitive function postoperatively compared to preoperative status</measure>
    <time_frame>at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months</time_frame>
    <description>Examinations were performed at baseline, pre-discharge and 3 months thereafter. Neurological status is assessed by a detailed clinical examination protocol. Cognitive function is evaluated using three different standardized neuropsychological tests and the Mini-Mental State Examination (MMSE).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Transaortic Transcatheter Aortic Valve Implantation</condition>
  <arm_group>
    <arm_group_label>Transaortic TAVI with EmbolX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device &quot;EmbolX&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transaortic TAVI without EmbolX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device &quot;EmbolX&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intra-aortic embolic protection management system; Embol-X</intervention_name>
    <description>The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients &quot;embolic showers&quot; which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.</description>
    <arm_group_label>Transaortic TAVI with EmbolX</arm_group_label>
    <arm_group_label>Transaortic TAVI without EmbolX</arm_group_label>
    <other_name>Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with symptomatic severe aortic valve stenosis (valve area &lt;0.8 cm2) are considered&#xD;
        candidates for TAVI (TAVR) if they have a logistic European System for Cardiac Operative&#xD;
        Risk Evaluation score (EuroSCORE) ≥15% or surgery is deemed to be at excessive risk because&#xD;
        of comorbidities and other risk factors not being captured by these scoring systems.&#xD;
        Indication for TAVI in the individual patient is discussed in a consensus conference of&#xD;
        cardiologists and cardiac surgeons, and patient's or physician's preference alone is not&#xD;
        considered adequate for decision making. The performance of TAVI in these patients is&#xD;
        approved by the local authorities. All patients have to agree to participate in the study,&#xD;
        and written informed consent is obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients are excluded from TAVI (TAVR) in the presence of any of the following conditions:&#xD;
&#xD;
          -  bicuspid aortic valve&#xD;
&#xD;
          -  aortic annulus diameter ≤18 or ≥27 mm&#xD;
&#xD;
          -  procelain aorta&#xD;
&#xD;
          -  unprotected left main disease&#xD;
&#xD;
          -  recent myocardial infarction or cerebrovascular event&#xD;
&#xD;
          -  sepsis or active endocarditis&#xD;
&#xD;
          -  severe aortic atheroma&#xD;
&#xD;
          -  left ventricular or atrial thrombus&#xD;
&#xD;
          -  active peptic ulcer&#xD;
&#xD;
          -  bleeding diathesis&#xD;
&#xD;
          -  hypersensitivity to antiplatelet therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 22, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>May 11, 2016</last_update_submitted>
  <last_update_submitted_qc>May 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West German Heart Center Essen</investigator_affiliation>
    <investigator_full_name>Matthias Thielmann</investigator_full_name>
    <investigator_title>PD. Dr. med. Matthias Thielmann</investigator_title>
  </responsible_party>
  <keyword>transaortic TAVI or TAVR</keyword>
  <keyword>embolic protection device</keyword>
  <keyword>EmbolX</keyword>
  <keyword>efficacy</keyword>
  <keyword>during transaortic TAVI</keyword>
  <keyword>reduce the incidence of new foci of restricted diffusion on diffusion-weighted MRI</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01735513
org study id: WDHZ-TC-TAo-EmbolX
nct id: NCT01735513
lead sponsor: 
has dmc: No
Study hypothesis: Reduction of cerebral embolic lesions during transcatheter aortic valve
      implantation by the use of an embolic protection device.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The detection of new morphological brain injury with new hyper-intense DW-MRI cerebral lesions on the post-treatment compared to the pretreatment MRI imaging
time frame: Postoperative day 1-3
description: MRI of the brain is obtained at the same time as clinical exams. Scans are performed on a 1.5-T MR unit and a circular polarized head coil. The imaging protocol includes a transversal DW, single shot echo-planar sequence of the whole brain. Diffusion images are processed to generate isotopic apparent diffusion coefficient maps using dedicated software allowing for proper classification of the lesions. Transversal fluid-attenuated inversion recovery and transversal T2-weighted turbo spin-echo sequences are also performed. Slice thickness is 5mm for all sequences. Scans are read by an experienced neuroradiologist blinded to the clinical data. The presence, number, volume and location of all new focal diffusion abnormalities were recorded.
measure: Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment
time frame: 30 days after treatment
description: Stroke and transient ischaemic attack is defined according to the Valve Academic Research Consortium (VARC) recommendation. In case of stroke, the modified Rankin scale (mRS) is assessed to categorize the patient's level of functional independence during daily activities.
measure: Neurocognitive function postoperatively compared to preoperative status
time frame: at baseline before treatment and at 1-3 days after treatment, at discharge and at 3 months
description: Examinations were performed at baseline, pre-discharge and 3 months thereafter. Neurological status is assessed by a detailed clinical examination protocol. Cognitive function is evaluated using three different standardized neuropsychological tests and the Mini-Mental State Examination (MMSE).
arm group label: Transaortic TAVI with EmbolX
arm group type: Experimental
description: Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation with the use of the embolic protection device "EmbolX"
arm group label: Transaortic TAVI without EmbolX
arm group type: Active Comparator
description: Subjects are randomized into this arm to receive a transaortic transcatheter aortic valve implantation without the use of the embolic protection device "EmbolX"
intervention type: Device
intervention name: Intra-aortic embolic protection management system; Embol-X
description: The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients "embolic showers" which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream.
arm group label: Transaortic TAVI with EmbolX
arm group label: Transaortic TAVI without EmbolX
other name: Embol-X, Edwards Lifesciences, Irvine, CA, USA. The EMBOL- X intra-aortic embolic management system.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: West German Heart Center Essen
investigator full name: Matthias Thielmann
investigator title: PD. Dr. med. Matthias Thielmann