<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/NCT03831087</url>
  </required_header>
  <id_info>
    <org_study_id>20171002-1653</org_study_id>
    <nct_id>NCT03831087</nct_id>
  </id_info>
  <brief_title>Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement</brief_title>
  <acronym>TAVR-CMR</acronym>
  <official_title>Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Johannes Kepler University of Linz</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Klinikum Wels-Grieskirchen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University Innsbruck</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to&#xD;
      clinical efficacy, defined as implantation success based on the VARC-2 criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide&#xD;
      Transcatheter Aortic Valve Replacement (TAVR-CMR).&#xD;
&#xD;
      Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal&#xD;
      Medicine III, Cardiology and Angiology, Innsbruck Medical University.&#xD;
&#xD;
      Planned Study Period: 2017-2023.&#xD;
&#xD;
      Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to&#xD;
      contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.&#xD;
&#xD;
      Design: Prospective, randomized, open-label, multi-centre trial.&#xD;
&#xD;
      Patients (planned): 270 patients.&#xD;
&#xD;
      Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based&#xD;
      on a local heart-team decision.&#xD;
&#xD;
      Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR&#xD;
      protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion.&#xD;
&#xD;
      Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after&#xD;
      6 months. The primary efficacy outcome is device implantation success at discharge. The&#xD;
      secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint&#xD;
      at baseline and at 6 months, as well as a comparison of imaging procedure related variables&#xD;
      (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus&#xD;
      document.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">August 5, 2023</completion_date>
  <primary_completion_date type="Actual">August 5, 2023</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient &lt; 20mmHg and no valve regurgitation &gt; mild)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">267</enrollment>
  <condition>Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>TAVR-CMR</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D &quot;whole-heart&quot; coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAVR-CT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All CT examinations will be performed on a 128-slice dual-source CT and high-pitch factor. Prospective electrocardiographic synchronization will be applied, triggered into the diastolic phase for the heart. An injected bolus of 70 to 110 mL of nonionic iodine contrast agent will be applied with 370 mg/mL iodine concentration, using an automatic injector at a flow rate of 5 mL/s, followed by 40 mL saline solution. Contrast agent volume for each patient will be calculated by scan time and body weight. Patients will be placed supine with arms overhead. The scan length range from supraaortic branches to the groins.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TAVR-CMR</intervention_name>
    <description>CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.</description>
    <arm_group_label>TAVR-CMR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>TAVR-CT</intervention_name>
    <description>CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.</description>
    <arm_group_label>TAVR-CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or&#xD;
             aortic valve index ≤ 0.6 cm²/m²) (1)&#xD;
&#xD;
          3. Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope&#xD;
&#xD;
          4. Patient is evaluated for TAVR&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to perform CMR&#xD;
&#xD;
          2. Contraindications to perform CT&#xD;
&#xD;
          3. Contraindications for TAVR or reduced life expectancy &lt; 1 year.&#xD;
&#xD;
          4. Known hypersensitivity to CMR or CT contrast agents&#xD;
&#xD;
          5. Childbearing potential or inability to exclude pregnancy&#xD;
&#xD;
          6. Inability to understand and follow study-related instructions&#xD;
&#xD;
          7. Severe renal insufficiency requiring renal replacement therapy&#xD;
&#xD;
          8. Severe hepatic insufficiency (Child-Pugh class B or C)&#xD;
&#xD;
          9. Post organ transplantation&#xD;
&#xD;
         10. Participation in another clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernhard Metzler, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Clinic of Internal Medicine III</name>
      <address>
        <city>Innsbruck</city>
        <state>Tirol</state>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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 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/NCT03831087
org study id: 20171002-1653
nct id: NCT03831087
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to
      clinical efficacy, defined as implantation success based on the VARC-2 criteria.
Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide
      Transcatheter Aortic Valve Replacement (TAVR-CMR).

      Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal
      Medicine III, Cardiology and Angiology, Innsbruck Medical University.

      Planned Study Period: 2017-2023.

      Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to
      contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points.

      Design: Prospective, randomized, open-label, multi-centre trial.

      Patients (planned): 270 patients.

      Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based
      on a local heart-team decision.

      Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR
      protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion.

      Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after
      6 months. The primary efficacy outcome is device implantation success at discharge. The
      secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint
      at baseline and at 6 months, as well as a comparison of imaging procedure related variables
      (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus
      document.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.
time frame: 6 months
description: The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient < 20mmHg and no valve regurgitation > mild)
arm group label: TAVR-CMR
arm group type: Other
description: All MR examinations will be performed with a 1.5-T clinical MR imaging unit (AVANTO_fit; Siemens, Erlangen, Germany). The MR protocol consists of a Navigator-gated free breathing 3D "whole-heart" coronary magnetic resonance angiography (MRA), axial 2D true fast imaging with steady-state free precession (true-FISP) during free breathing covering whole body trunk and a coronal 3D fast low-angle shot (FLASH) Gd-MRA.
arm group label: TAVR-CT
arm group type: Other
description: All CT examinations will be performed on a 128-slice dual-source CT and high-pitch factor. Prospective electrocardiographic synchronization will be applied, triggered into the diastolic phase for the heart. An injected bolus of 70 to 110 mL of nonionic iodine contrast agent will be applied with 370 mg/mL iodine concentration, using an automatic injector at a flow rate of 5 mL/s, followed by 40 mL saline solution. Contrast agent volume for each patient will be calculated by scan time and body weight. Patients will be placed supine with arms overhead. The scan length range from supraaortic branches to the groins.
intervention type: Diagnostic Test
intervention name: TAVR-CMR
description: CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
arm group label: TAVR-CMR
intervention type: Diagnostic Test
intervention name: TAVR-CT
description: CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
arm group label: TAVR-CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Bernhard Metzler, Prof.
role: Principal Investigator
affiliation: Medical University Innsbruck
facility: 
country: Austria
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
sharing ipd: No