<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/NCT03811119</url>
  </required_header>
  <id_info>
    <org_study_id>MASH TAVI 06-09-2018</org_study_id>
    <nct_id>NCT03811119</nct_id>
  </id_info>
  <brief_title>Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial</brief_title>
  <acronym>MASH-TAVI</acronym>
  <official_title>MANTA™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erasmus Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to&#xD;
      suture-based VCDs in preventing vascular access site complications in patients undergoing&#xD;
      transfemoral transcatheter aortic valve replacement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see summary&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2018</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>
    <intervention_model_description>Open label randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite rate of major- and minor vascular complications according to VARC-2</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a Major Vascular Complication according to VARC-2</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>total number of participants major vascular complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a Minor Vascular Complication according to VARC-2</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>total number of participants minor vascular complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause death rate</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a major- or life threatening bleeding according to VARC-2</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>total number of participants with major/life-threatening bleedings</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for transfusions for access site related bleeding/complications</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>Total number of transfusions of RBC because of site-related bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with vascular closure device failure</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to hemostasis</measure>
    <time_frame>During the TAVI procedure</time_frame>
    <description>After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>During the TAVI procedure</time_frame>
    <description>The total procedural time in minutes will be compared between the two treatment arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5</measure>
    <time_frame>Between transcatheter aortic valve implantation and 30 days follow-up</time_frame>
    <description>Clinically relevant bleeding defined as BARC 2, 3 and 5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to a maximum of 30 days after the TAVI procedure</time_frame>
    <description>The total length of hospital stay in days will be compared between the two treatment arms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>MANTA vascular closure device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arteriotomy closure with a collagen-based vascular closure device (MANTA™)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suture based vascular closure device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MANTA vascular closure device</intervention_name>
    <description>Collagen based vascular closure device</description>
    <arm_group_label>MANTA vascular closure device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Suture based vascular closure device</intervention_name>
    <description>Suture based vascular closure device (ProGlide)</description>
    <arm_group_label>Suture based vascular closure device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with&#xD;
             any commercially-available transcatheter heart valve (THV)&#xD;
&#xD;
          -  Common femoral artery diameter &gt; 5.0mm (14 - 22F compatible)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic leg ischaemia&#xD;
&#xD;
          -  Previous thromboendarterectomy or plastic patch of the common femoral artery&#xD;
&#xD;
          -  Previous implantation of a suture-based VCD less than 30 days before, or a plug-based&#xD;
             VCD within 6 months&#xD;
&#xD;
          -  Unilateral or bilateral lower extremity amputation&#xD;
&#xD;
          -  Systemic infection or a local infection at or near the access site&#xD;
&#xD;
          -  Allergy to the components any of both devices (i.e. bovine materials or any other&#xD;
             device material, including collagen and/or collagen products, polyglycolic or&#xD;
             polylactic acid, stainless steel or nickel)&#xD;
&#xD;
          -  Active bleeding or bleeding diathesis including thrombocytopenia (platelet count&#xD;
             &lt;50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease&#xD;
&#xD;
          -  Patients in whom continuous oral anticoagulation therapy cannot be stopped for the&#xD;
             peri-procedural period or patients with INR &gt;1.8 at the time of the procedure&#xD;
&#xD;
          -  Patient unable to be adequately anti-coagulated for the procedure&#xD;
&#xD;
          -  Morbidly obese or cachectic (BMI &gt;40 kg/m2 or &lt;20 kg/m2)&#xD;
&#xD;
          -  Anatomical and procedural contraindication for suture-based or Manta closure (lack of&#xD;
             proper puncture site in the common femoral artery in terms of calcification, size, and&#xD;
             atherosclerotic disease)&#xD;
&#xD;
          -  Absence of computed tomographic data of the access site before the procedure&#xD;
&#xD;
          -  Patient cannot adhere to or complete the investigational protocol for any reason&#xD;
             including but not limited to geographical residence, psychiatric condition or life&#xD;
             threatening disease&#xD;
&#xD;
          -  Known pregnancy at time of randomization (in women of childbearing potential a&#xD;
             negative pregnancy test is mandatory)&#xD;
&#xD;
          -  Participating in trials in which the primary endpoint includes bleeding or vascular&#xD;
             complications&#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>Nicolas M Van Mieghem, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Erasmus University Medical Center Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <zip>3000 CA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 24, 2021</last_update_submitted>
  <last_update_submitted_qc>March 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Nicolas van Mieghem</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vascular Closure Devices</keyword>
  <keyword>Transcatheter Aortic Valve Implantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no sharing of individual data (no permission from participants. GDPR)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03811119
org study id: MASH TAVI 06-09-2018
nct id: NCT03811119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To investigate whether the collagen-based MANTA vascular closure device (VCD) is superior to
      suture-based VCDs in preventing vascular access site complications in patients undergoing
      transfemoral transcatheter aortic valve replacement.
see summary
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open label randomized trial
primary purpose: Treatment
masking: None (Open Label)
measure: Composite rate of major- and minor vascular complications according to VARC-2
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: The primary endpoint will consist of the composite of major- and minor vascular complications according to the Valve Academic Research Consortium (VARC)-2 at 30 days follow-up.
measure: Number of Participants with a Major Vascular Complication according to VARC-2
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: total number of participants major vascular complications
measure: Number of Participants with a Minor Vascular Complication according to VARC-2
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: total number of participants minor vascular complications
measure: All-cause death rate
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: A distinction between cardiac-, non-cardiac vascular and non-cardiovascular death will be made
measure: Number of Participants with a major- or life threatening bleeding according to VARC-2
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: total number of participants with major/life-threatening bleedings
measure: Need for transfusions for access site related bleeding/complications
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: Total number of transfusions of RBC because of site-related bleeding
measure: Number of Participants with vascular closure device failure
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: Failure of a closure device to achieve haemostasis at the arteriotomy site leading to alternative treatment (other than manual compression or adjunctive endovascular ballooning)
measure: Time to hemostasis
time frame: During the TAVI procedure
description: After the use of a vascular closure device the time to hemostasis will be classified as immediate hemostasis, hemostasis after 5 minutes manual compression, hemostasis after 10 minutes manual compression, hemostasis after endovascular ballooning, hemostasis after endovascular intervention or hemostasis after surgical intervention
measure: Total procedure time
time frame: During the TAVI procedure
description: The total procedural time in minutes will be compared between the two treatment arms
measure: Number of Participants with a clinically relevant bleeding defined as BARC 2, 3 and 5
time frame: Between transcatheter aortic valve implantation and 30 days follow-up
description: Clinically relevant bleeding defined as BARC 2, 3 and 5
measure: Length of hospital stay
time frame: Up to a maximum of 30 days after the TAVI procedure
description: The total length of hospital stay in days will be compared between the two treatment arms
arm group label: MANTA vascular closure device
arm group type: Active Comparator
description: Arteriotomy closure with a collagen-based vascular closure device (MANTA™)
arm group label: Suture based vascular closure device
arm group type: Active Comparator
description: Arteriotomy closure with 2 or more suture-based vascular closure devices (ProGlide)
intervention type: Device
intervention name: MANTA vascular closure device
description: Collagen based vascular closure device
arm group label: MANTA vascular closure device
intervention type: Device
intervention name: Suture based vascular closure device
description: Suture based vascular closure device (ProGlide)
arm group label: Suture based vascular closure device
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas M Van Mieghem, MD, PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Nicolas van Mieghem
investigator title: Principal Investigator
mesh term: Aortic Valve Stenosis
sharing ipd: No
ipd description: no sharing of individual data (no permission from participants. GDPR)