xml: <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/NCT05989074</url>
    </required_header>
    <id_info>
      <org_study_id>BSR-14</org_study_id>
      <nct_id>NCT05989074</nct_id>
    </id_info>
    <brief_title>All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve</brief_title>
    <official_title>All Women A Multicenter Randomized Clinical Trial Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve in a Women Population</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ceric Sàrl</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Biosensors International</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Cardiovascular Research Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ceric Sàrl</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>
        Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower&#xD;
        mean gradient assessed by TTE compared to balloon-expandable valve systems in a female&#xD;
        patient population with symptomatic severe aortic stenosis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve&#xD;
        implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE)&#xD;
        at 30 days post procedure, compared to balloon-expandable valve systems in a female patient&#xD;
        population with symptomatic severe aortic stenosis.&#xD;
  &#xD;
        Patients in both arm will receive anticoagulants according to routine practice of the&#xD;
        hospital.&#xD;
  &#xD;
        Patients will be followed-up until 1 year after the procedure.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.</measure>
      <time_frame>At 30 Days</time_frame>
      <description>Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Technical success assessed by composite criteria</measure>
      <time_frame>Up to the end of the time when patient exit the procedure room</time_frame>
      <description>Freedom from mortality&#xD;
  Successful access, delivery of the device, and retrieval of the delivery system&#xD;
  Correct positioning of a single prosthetic heart valve into the proper anatomical location&#xD;
  Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device success assessed by composite criteria</measure>
      <time_frame>At 30 days</time_frame>
      <description>Technical success&#xD;
  Freedom from mortality&#xD;
  Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication&#xD;
  Intended performance of the valve‡ (mean gradient &lt;20 mmHg, peak velocity &lt;3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early safety assessed by composite criteria</measure>
      <time_frame>At 30 days</time_frame>
      <description>Freedom from all-cause mortality&#xD;
  Freedom from all stroke&#xD;
  Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding)&#xD;
  Freedom from major vascular, access-related, or cardiac structural complication&#xD;
  Freedom from acute kidney injury stage 3 or 4&#xD;
  Freedom from moderate or severe aortic regurgitation&#xD;
  Freedom from new permanent pacemaker due to procedure-related conduction abnormalities&#xD;
  Freedom from surgery or intervention related to the device</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical efficacy assessed by composite criteria</measure>
      <time_frame>At 1 year</time_frame>
      <description>Freedom from all-cause mortality&#xD;
  Freedom from all stroke&#xD;
  Freedom from hospitalization for procedure- or valve-related causes&#xD;
  Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score &lt;45 or decline from baseline of &gt;10 point (i.e. Unfavourable Outcome)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Aortic Stenosis, Severe</condition>
    <arm_group>
      <arm_group_label>ALLEGRA</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Balloon-expandable TAVI</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ALLEGRA TAVI System TF</intervention_name>
      <description>Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital</description>
      <arm_group_label>ALLEGRA</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ballon-expandable valve system</intervention_name>
      <description>Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.</description>
      <arm_group_label>Balloon-expandable TAVI</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female sex&#xD;
  &#xD;
            2. Age ≥ 75 years (according to ESC/EACTS, Guidelines for the management of valvular&#xD;
               heart disease)&#xD;
  &#xD;
            3. Severe calcific aortic valve stenosis defined as follows: high-gradient aortic&#xD;
               stenosis (mean pressure gradient across aortic valve &gt; 40 mmHg or peak velocity &gt; 4.0&#xD;
               m/s) Symptomatic aortic valve stenosis with New York Heart Association (NYHA) Class&#xD;
               ≥II&#xD;
  &#xD;
            4. ECG-gated Multi-Slice Computed Tomographic (MSCT) measurements determined an aortic&#xD;
               annulus perimeter-derived average diameter &gt;19 mm and &lt;27.4 mm or area-derived&#xD;
               diameter &gt;18 and &lt;28 mm&#xD;
  &#xD;
            5. Anatomy suitable for trans-femoral TAVI for both devices used in the study, including&#xD;
               a minimum femoral diameter of 6 mm.&#xD;
  &#xD;
            6. Subject with a documented local Heart Team (HT) indication for TF TAVI&#xD;
  &#xD;
            7. Life expectancy longer than 1 year.&#xD;
  &#xD;
            8. Willingness to undergo clinical and echocardiographic follow-up after the procedure.&#xD;
  &#xD;
            9. Subject can understand the purpose of the clinical investigation, has signed&#xD;
               voluntarily the informed consent form and is agreeing to the scheduled follow-up&#xD;
               requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Male sex&#xD;
  &#xD;
            2. Non-calcific acquired aortic stenosis&#xD;
  &#xD;
            3. Native unicuspid/bicuspid aortic valve or congenital aortic abnormality&#xD;
  &#xD;
            4. Previous implantation of heart valve in any position&#xD;
  &#xD;
            5. Severe aortic regurgitation (&gt; 3+)&#xD;
  &#xD;
            6. Severe mitral regurgitation (&gt; 3+)&#xD;
  &#xD;
            7. Severe tricuspid regurgitation (&gt; 3+)&#xD;
  &#xD;
            8. Severe left ventricular dysfunction (Left Ventricular Ejection Fraction (LVEF) &lt; 30%)&#xD;
  &#xD;
            9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation&#xD;
  &#xD;
           10. Untreated cardiac conduction disease in need of pacemaker implantation&#xD;
  &#xD;
           11. Evidence of acute Myocardial Infarction (MI) less than 30 days before signing informed&#xD;
               consent&#xD;
  &#xD;
           12. Any need for emergency surgery&#xD;
  &#xD;
           13. Any active bleeding that precludes anticoagulation&#xD;
  &#xD;
           14. Liver failure (Child-C)&#xD;
  &#xD;
           15. End-stage renal disease requiring chronic dialysis or creatinine clearance &lt; 30cc/min&#xD;
  &#xD;
           16. Pulmonary hypertension (systolic pressure &gt; 80mmHg)&#xD;
  &#xD;
           17. A known hypersensitivity or contraindication to all anticoagulation/antiplatelet&#xD;
               regimens (or inability to be anticoagulated for the index procedure), to cobalt&#xD;
               chromium, to bovine and/or collagen, glutaraldehyde or contrast media&#xD;
  &#xD;
           18. Any medical, social or psychological condition that in the opinion of the investigator&#xD;
               precludes the subject from giving appropriate consent or adherence to the required&#xD;
               follow-up procedures&#xD;
  &#xD;
           19. Currently participating in another drug or device trial (excluding observational&#xD;
               registries) for which the primary endpoint has not been assessed&#xD;
  &#xD;
           20. Subject under judicial protection, tutorship or curatorship (for France only)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Biological gender</gender_description>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alaide Chieffo, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ospedale San Raffaele</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Ignacio Cruz-Gonzalez, Prof</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Salamanca</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nozomi Watanabe</last_name>
      <phone>+33 (0)6 61 38 94 80</phone>
      <email>nwatanabe@cerc-europe.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Laure Morsiani</last_name>
      <phone>+33 (0)1 76 73 92 36</phone>
      <email>lmorsiani@cerc-europe.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fexofenadine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989074
  org study id: BSR-14
  nct id: NCT05989074
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower
        mean gradient assessed by TTE compared to balloon-expandable valve systems in a female
        patient population with symptomatic severe aortic stenosis
  Study is aimed to demonstrate that the self-expandable Allegra transcatheter aortic valve
        implantation (TAVI) system provides lower mean gradient assessed by Transthoracic Echo (TTE)
        at 30 days post procedure, compared to balloon-expandable valve systems in a female patient
        population with symptomatic severe aortic stenosis.
  
        Patients in both arm will receive anticoagulants according to routine practice of the
        hospital.
  
        Patients will be followed-up until 1 year after the procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
  time frame: At 30 Days
  description: Trans-aortic mean gradient measured by TTE 30 days after the TAVI procedure.
  measure: Technical success assessed by composite criteria
  time frame: Up to the end of the time when patient exit the procedure room
  description: Freedom from mortality
  Successful access, delivery of the device, and retrieval of the delivery system
  Correct positioning of a single prosthetic heart valve into the proper anatomical location
  Freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
  measure: Device success assessed by composite criteria
  time frame: At 30 days
  description: Technical success
  Freedom from mortality
  Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
  Intended performance of the valve‡ (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)
  measure: Early safety assessed by composite criteria
  time frame: At 30 days
  description: Freedom from all-cause mortality
  Freedom from all stroke
  Freedom from Valve Academic Research Consortium (VARC) type 2-4 bleeding (in trials where control group is surgery, it is appropriate to include only Type 3 and 4 bleeding)
  Freedom from major vascular, access-related, or cardiac structural complication
  Freedom from acute kidney injury stage 3 or 4
  Freedom from moderate or severe aortic regurgitation
  Freedom from new permanent pacemaker due to procedure-related conduction abnormalities
  Freedom from surgery or intervention related to the device
  measure: Clinical efficacy assessed by composite criteria
  time frame: At 1 year
  description: Freedom from all-cause mortality
  Freedom from all stroke
  Freedom from hospitalization for procedure- or valve-related causes
  Freedom from Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score <45 or decline from baseline of >10 point (i.e. Unfavourable Outcome)
  arm group label: ALLEGRA
  arm group type: Experimental
  description: ALLEGRA Delivery System TF will be administered.Patient will receive Anticoagulation medication according to the site-specific standard of care
  arm group label: Balloon-expandable TAVI
  arm group type: Active Comparator
  description: Patient will receive any kind of CE-marked balloon-expandable valve, and anticoagulation medication according to the site-specific standard of care
  intervention type: Device
  intervention name: ALLEGRA TAVI System TF
  description: Patients receive ALLEGRA TAVI System TF. Patient will receive medication according to routine practice of the hospital
  arm group label: ALLEGRA
  intervention type: Device
  intervention name: Ballon-expandable valve system
  description: Patients receive any kind of CE-marked balloon expandable valve system, used at the hospital. Patient will receive medication according to routine practice of the hospital.
  arm group label: Balloon-expandable TAVI
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Biological gender
  minimum age: 75 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alaide Chieffo, Prof
  role: Principal Investigator
  affiliation: Ospedale San Raffaele
  last name: Ignacio Cruz-Gonzalez, Prof
  role: Principal Investigator
  affiliation: University of Salamanca
  last name: Nozomi Watanabe
  phone: +33 (0)6 61 38 94 80
  email: nwatanabe@cerc-europe.org
  last name: Laure Morsiani
  phone: +33 (0)1 76 73 92 36
  email: lmorsiani@cerc-europe.org
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  mesh term: Fexofenadine
  sharing ipd: Undecided