<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/NCT03805711</url>
  </required_header>
  <id_info>
    <org_study_id>HLT 1801</org_study_id>
    <nct_id>NCT03805711</nct_id>
  </id_info>
  <brief_title>HLT Meridian Valve CE Mark Trial</brief_title>
  <acronym>RADIANT CE</acronym>
  <official_title>Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HLT Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HLT Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and performance of the HLT System in patients with symptomatic heart&#xD;
      disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate&#xD;
      or High Risk for aortic valve replacement surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, non-randomized, single arm, multi-center CE Mark trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision to stop enrollment.&#xD;
  </why_stopped>
  <start_date type="Actual">July 12, 2019</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Freedom from all-cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Device Performance</measure>
    <time_frame>During the Procedure</time_frame>
    <description>Device implant success defined as:&#xD;
Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient &lt;20mmHg or peak aortic valve velocity &lt;3 m/sec, AND no moderate or severe AR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-procedural Valve Performance</measure>
    <time_frame>14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months</time_frame>
    <description>Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters:&#xD;
Aortic valve area (AVA)&#xD;
Aortic valve regurgitation (AR)&#xD;
Aortic valve gradient (Mean and Peak)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Adverse Events</measure>
    <time_frame>Throughout the 5-year follow-up period, assessed annually at a minimum</time_frame>
    <description>All adverse events through the one (1) year follow up period&#xD;
All Serious Adverse Events through the five (5) year follow up period&#xD;
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Aortic Valve Stenosis</condition>
  <arm_group>
    <arm_group_label>Aortic Valve Replacement with HLT® Transcatheter System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HLT® Transcatheter System</intervention_name>
    <description>Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).</description>
    <arm_group_label>Aortic Valve Replacement with HLT® Transcatheter System</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of&#xD;
             the following:&#xD;
&#xD;
               1. Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2&#xD;
&#xD;
               2. Mean aortic valve gradient ≥ 40 mmHg&#xD;
&#xD;
               3. Peak aortic valve velocity ≥ 4 m/sec&#xD;
&#xD;
          -  Symptoms due to severe aortic stenosis resulting in one of the following:&#xD;
&#xD;
               1. NYHA Functional Classification of II or greater&#xD;
&#xD;
               2. Presence of angina&#xD;
&#xD;
               3. Presence of syncope&#xD;
&#xD;
          -  Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range&#xD;
             is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of&#xD;
             pre-procedure imaging.&#xD;
&#xD;
          -  Patient is considered intermediate or high risk to undergo surgical aortic valve&#xD;
             replacement with one of the following:&#xD;
&#xD;
               1. Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%&#xD;
&#xD;
               2. High Surgical Risk: STS-PROM score of ≥ 8%&#xD;
&#xD;
               3. Documented heart team agreement of risk for surgical aortic valve replacement&#xD;
                  (SAVR) due to other factors not captured by risk-scores (i.e. frailty or&#xD;
                  comorbidities)&#xD;
&#xD;
          -  Geographically available, willing to comply with follow up and able to provide written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a coronary height of &lt;10mm, or otherwise determined to be at high risk&#xD;
             for coronary obstruction&#xD;
&#xD;
          -  Patients with low flow/low gradient aortic stenosis&#xD;
&#xD;
          -  Patients with significant annular or LVOT calcification that could compromise&#xD;
             procedural success&#xD;
&#xD;
          -  Pre-existing prosthetic heart valve in any position, or prosthetic ring&#xD;
&#xD;
          -  Severe aortic, mitral or tricuspid valve regurgitation&#xD;
&#xD;
          -  Untreated clinically significant coronary artery disease requiring revascularization&#xD;
&#xD;
          -  Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive&#xD;
             calcification or severe tortuosity) that would preclude passage of 18 Fr catheters&#xD;
             from the femoral arterial access to the aorta as evidenced by peripheral MSCT&#xD;
&#xD;
          -  Need for emergent surgery or intervention other than the investigational procedure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Axel Linke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <disposition_first_submitted>May 15, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>May 15, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 19, 2020</disposition_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aortic Stenosis</keyword>
  <keyword>Transcatheter Aortic Valve Replacement</keyword>
  <keyword>TAVR</keyword>
  <keyword>TAVI</keyword>
  <keyword>Aortic Valve</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>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03805711
org study id: HLT 1801
nct id: NCT03805711
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
To evaluate the safety and performance of the HLT System in patients with symptomatic heart
      disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate
      or High Risk for aortic valve replacement surgery.
Prospective, non-randomized, single arm, multi-center CE Mark trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All-cause mortality
time frame: 30 days
description: Freedom from all-cause mortality
measure: Procedural Device Performance
time frame: During the Procedure
description: Device implant success defined as:
Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak aortic valve velocity <3 m/sec, AND no moderate or severe AR)
measure: Post-procedural Valve Performance
time frame: 14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
description: Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters:
Aortic valve area (AVA)
Aortic valve regurgitation (AR)
Aortic valve gradient (Mean and Peak)
measure: Rate of Adverse Events
time frame: Throughout the 5-year follow-up period, assessed annually at a minimum
description: All adverse events through the one (1) year follow up period
All Serious Adverse Events through the five (5) year follow up period
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years
arm group label: Aortic Valve Replacement with HLT® Transcatheter System
arm group type: Experimental
description: Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System
intervention type: Device
intervention name: HLT® Transcatheter System
description: Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).
arm group label: Aortic Valve Replacement with HLT® Transcatheter System
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Axel Linke, MD
role: Principal Investigator
affiliation: Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No