<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/NCT03287856</url>
  </required_header>
  <id_info>
    <org_study_id>NVT03VIV</org_study_id>
    <nct_id>NCT03287856</nct_id>
  </id_info>
  <brief_title>NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis</brief_title>
  <acronym>VIVALL</acronym>
  <official_title>Investigation of the Safety and Performance of the NVT ALLEGRA TAVI System TF in Patients With Failed Surgical Aortic Bioprosthesis and Elevated Surgical Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NVT GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NVT GmbH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates the technical feasibility of the replacement of failed surgical&#xD;
      bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the&#xD;
      safety and performance profile&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Actual">October 27, 2019</completion_date>
  <primary_completion_date type="Actual">September 27, 2018</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>Mean pressure gradient</measure>
    <time_frame>immediately after index-procedure</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>30-days survival</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of participants with overall survival at 30 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic parameters</measure>
    <time_frame>up to12 months</time_frame>
    <description>pressure gradient, effective orifice area, velocity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical success of implantation</measure>
    <time_frame>immediately after index-procedure</time_frame>
    <description>defined as absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no severe (&lt;0.65 cm2/m2) prosthesis - patient mismatch AND mean aortic valve gradient &lt;20 mmHg AND no moderate or severe prosthetic valve regurgitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early safety</measure>
    <time_frame>30 days</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time related valve safety</measure>
    <time_frame>up to 12 months</time_frame>
    <description>structural valve deterioration as defined by&#xD;
requiring repeat procedure (transcatheter or surgical heart valve replacement)&#xD;
valve-related dysfunction defined by&#xD;
mean aortic valve gradient ≥20 mmHg AND&#xD;
no moderate or severe prosthetic valve regurgitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Pacemaker implantation</measure>
    <time_frame>up to 12 months</time_frame>
    <description>Proportion of patients with pacemaker implantations after index-procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NYHA classification</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Transcatheter Aortic Valve Implantation</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcatheter Aortic Valve Implantation (TAVI)</intervention_name>
    <description>Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years&#xD;
&#xD;
          -  Symptomatic degeneration of aortic bioprosthesis showing echocardiographically mean&#xD;
             aortic gradient &gt;40mmHg or peak jet velocity &gt;4.0m/s and AVA&lt;1.0cm2 OR symptomatic&#xD;
             patients with severe bioprosthetic valve insufficiency.&#xD;
&#xD;
          -  High risk for redo surgery defined by STS ≥10% / EuroScore II ≥7% OR as assessed by&#xD;
             the heart team&#xD;
&#xD;
          -  Has signed the Patient Informed Consent Form&#xD;
&#xD;
          -  Willing and able to comply with requirements of the study, including all follow-up&#xD;
             visits&#xD;
&#xD;
          -  Female patients of childbearing potential have a negative pregnancy test ≤7 days&#xD;
             before the procedure and are willing to use a reliable method of birth control for the&#xD;
             duration of study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low position of the coronary ostia, especially in combination with shallow sinuses&#xD;
&#xD;
          -  Echocardiographic evidence of intracardiac mass, thrombus or vegetation&#xD;
&#xD;
          -  Significant aortic disease such as severe obstructive calcification or marked&#xD;
             tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI&#xD;
             System TF&#xD;
&#xD;
          -  Iliofemoral vessel conditions such as severe obstructive calcification, severe&#xD;
             tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath&#xD;
             or make endovascular access to the aortic valve impossible&#xD;
&#xD;
          -  Severe mitral insufficiency&#xD;
&#xD;
          -  Internal diameter of the bioprosthesis is ≤16 mm or &gt;28 mm&#xD;
&#xD;
          -  Patient prosthesis mismatch (EOAi ≤0.65 cm2/m2) as the underlying cause of the poor&#xD;
             valve function and need for re-intervention&#xD;
&#xD;
          -  Non-valvular stenosis as the underlying cause of the poor valve function and need for&#xD;
             re-intervention&#xD;
&#xD;
          -  Failing pre-existing prosthetic heart valve or prosthetic ring in any other position&#xD;
             than aortic&#xD;
&#xD;
          -  Partially detached leaflets that in the aortic position may obstruct a coronary&#xD;
             ostium.&#xD;
&#xD;
          -  Existence of aortic conduit, aortic arch replacement, stentless bioprosthesis and&#xD;
             autologous valve replacement&#xD;
&#xD;
          -  Paravalvular leak of the failing surgical bioprosthesis (between failing surgical&#xD;
             bioprosthesis and native annulus)&#xD;
&#xD;
          -  LVEF &lt;20%&#xD;
&#xD;
          -  Evidence of active endocarditis or other acute infections&#xD;
&#xD;
          -  End stage renal disease requiring chronic dialysis or creatinine clearance &lt;20 ml/min&#xD;
             or serum creatinine &gt;3.0 mg/dl (264 µmol/l)&#xD;
&#xD;
          -  Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or&#xD;
             contraindication to anticoagulant or anti-platelet medication or to Nitinol alloy or&#xD;
             to bovine tissue&#xD;
&#xD;
          -  Evidence of an acute myocardial infarction within the past 30 days&#xD;
&#xD;
          -  Cerebral vascular accident (TIA, Stroke) within past 6 months (≤180 days)&#xD;
&#xD;
          -  Evidence of active peptic ulcer or upper gastrointestinal bleeding within past 90 days&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Hemodynamic instability (e.g. cardiogenic shock) requiring inotropic support or&#xD;
             mechanical heart assistance (e.g. VAD, IABP)&#xD;
&#xD;
          -  Uncontrolled (therapy resistant) atrial fibrillation&#xD;
&#xD;
          -  Need for emergency surgery for any reason&#xD;
&#xD;
          -  Life expectancy ≤ 12 months due to other medical illness&#xD;
&#xD;
          -  Currently participating in another investigational drug or device study&#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>Ulrich Schaefer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitäres Herzzentrum Hamburg, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Segeberger Kliniken, Herzzentrum</name>
      <address>
        <city>Bad Segeberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immanuel Klinik Bernau Herzzentrum Brandenburg</name>
      <address>
        <city>Bernau bei Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)</name>
      <address>
        <city>Halle (Saale)</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäres Herzzentrum Hamburg GmbH</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>https://eurointervention.pcronline.com/article/thirty-day-outcomes-of-a-novel-transcatheter-heart-valve-to-treat-degenerated-surgical-valves-the-vivall-multi-center-single-arm-pilot-study</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Schafer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J, Koban C, Allali A, Schmidt T, Charitos E, Conradi L. Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EuroIntervention. 2019 Oct 4;15(9):e757-e763. doi: 10.4244/EIJ-D-19-00331.</citation>
    <PMID>31355750</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Valve-in-valve</keyword>
  <keyword>TAVI</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/NCT03287856
org study id: NVT03VIV
nct id: NCT03287856
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study investigates the technical feasibility of the replacement of failed surgical
      bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the
      safety and performance profile
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean pressure gradient
time frame: immediately after index-procedure
measure: 30-days survival
time frame: 30 days
description: Proportion of participants with overall survival at 30 days
measure: Cardiovascular mortality
time frame: 30 days
measure: Hemodynamic parameters
time frame: up to12 months
description: pressure gradient, effective orifice area, velocity
measure: Technical success of implantation
time frame: immediately after index-procedure
description: defined as absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no severe (<0.65 cm2/m2) prosthesis - patient mismatch AND mean aortic valve gradient <20 mmHg AND no moderate or severe prosthetic valve regurgitation
measure: Early safety
time frame: 30 days
description: 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
measure: Time related valve safety
time frame: up to 12 months
description: structural valve deterioration as defined by
requiring repeat procedure (transcatheter or surgical heart valve replacement)
valve-related dysfunction defined by
mean aortic valve gradient ≥20 mmHg AND
no moderate or severe prosthetic valve regurgitation
measure: New Pacemaker implantation
time frame: up to 12 months
description: Proportion of patients with pacemaker implantations after index-procedure
measure: NYHA classification
time frame: up to 12 months
arm group label: Treatment
arm group type: Experimental
description: Transcatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis
intervention type: Device
intervention name: Transcatheter Aortic Valve Implantation (TAVI)
description: Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrich Schaefer, MD
role: Principal Investigator
affiliation: Universitäres Herzzentrum Hamburg, Germany
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: https://eurointervention.pcronline.com/article/thirty-day-outcomes-of-a-novel-transcatheter-heart-valve-to-treat-degenerated-surgical-valves-the-vivall-multi-center-single-arm-pilot-study
description: Related Info
citation: Schafer U, Butter C, Landt M, Frerker C, Treede H, Schirmer J, Koban C, Allali A, Schmidt T, Charitos E, Conradi L. Thirty-day outcomes of a novel transcatheter heart valve to treat degenerated surgical valves: the VIVALL multicentre, single-arm, pilot study. EuroIntervention. 2019 Oct 4;15(9):e757-e763. doi: 10.4244/EIJ-D-19-00331.
PMID: 31355750
responsible party type: Sponsor