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/NCT05983458</url>
    </required_header>
    <id_info>
      <org_study_id>SAFARI</org_study_id>
      <nct_id>NCT05983458</nct_id>
    </id_info>
    <brief_title>SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients</brief_title>
    <acronym>SAFARI</acronym>
    <official_title>Safe and Fast Discharge With Acurate Valve in Low Risk Tavi Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maria Cecilia Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maria Cecilia Hospital</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>
        Recent evidence from scientific literature supported the extension of TAVI procedures to&#xD;
        lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk&#xD;
        patient populations is still limited by complications and costs, with a large disparity&#xD;
        between clinical trials and real-world scenarios suggesting still long hospitalizations after&#xD;
        TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with&#xD;
        many studies showing a more favourable cost profile associated with early discharges&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In most cases, prolongation of hospital stay is mainly related to electrical, renal, vascular&#xD;
        or neurological complications. With increasing operators' experience, careful procedure&#xD;
        planning and technology improvement, procedure-related complications are reducing, with&#xD;
        favourable effects in terms of postprocedural length-of-stay and related costs.&#xD;
  &#xD;
        This is particularly true for lower risk populations. Being surgery the gold standard for&#xD;
        treating aortic valve disease in low-risk patients, the outcomes after TAVI in this&#xD;
        population should meet high standards to be accepted. In particular, optimal results should&#xD;
        not be limited to procedural success but last over time, ensuring both a long-life expectancy&#xD;
        and a good quality of life. TAVI efficacy in this population should include the absence of&#xD;
        residual paravalvular leaks, no need for permanent pacemakers, no cerebral embolism and the&#xD;
        opportunity of easily re-accessing coronary arteries in the future. In particular, many&#xD;
        questions have been raised about the difficulty of coronary re-access following use of the&#xD;
        EvolutR/PRO valves compared to the Sapien 3 valves. Thus, valves with a larger open-celled&#xD;
        design (ACURATE neo, Portico or JENA) are potentially more favourable for coronary access and&#xD;
        could be considered in patients likely to require repeated re-access to coronary arteries.&#xD;
  &#xD;
        Acurate Neo Valve showed good procedural results in high-risk subsets of patients. Although&#xD;
        not tested in large-scale trials involving low risk patients, due to its unique morphology it&#xD;
        could offer peculiar advantages, compared to other devices, including:&#xD;
  &#xD;
          1. Low permanent pacemaker rates&#xD;
  &#xD;
          2. Easier coronary re-access&#xD;
  &#xD;
          3. Low paravalvular leak rate (novel Neo 2 technology) The aim of this study was to report&#xD;
             on the feasibility and safety of early discharge (defined as discharge within 48 hours&#xD;
             from the procedure) of selected low-risk patients after transfemoral TAVI with the novel&#xD;
             Acurate Neo2 valve platform&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 26, 2022</start_date>
    <completion_date type="Anticipated">August 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve</measure>
      <time_frame>12 months</time_frame>
      <description>• Freedom from mortality</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Stenoses, Aortic</condition>
    <arm_group>
      <arm_group_label>patients with severe symptomatic aortic stenosis</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Real-world patients with severe symptomatic aortic stenosis allocated to TAVI treatment by local heart Team will be included in the study according to the inclusion and exclusion criteria specified below.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Transaortic valve replacement</intervention_name>
      <description>TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided.&#xD;
  For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications.&#xD;
  All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.</description>
      <arm_group_label>patients with severe symptomatic aortic stenosis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age &gt;=18 and =&lt; 83 years&#xD;
  &#xD;
            2. Normal PR interval at 12-lead electrocardiogram (ECG)&#xD;
  &#xD;
            3. No evidence of Right bundle branch block (RBBB) or high-degree Atrioventricular Block&#xD;
               ( AV) blocks at 12-lead ECG&#xD;
  &#xD;
            4. eGFR &gt; 50 ml/min/1.73 m2&#xD;
  &#xD;
            5. Ilio-femoral anatomy compatible with transfemoral transcatheter aortic valve&#xD;
               implantation (TAVI)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Inability to provide informed consent&#xD;
  &#xD;
            2. Not suitable anatomy for transfemoral access&#xD;
  &#xD;
            3. Need for general anaesthesia (e.g. hemodynamic instability)&#xD;
  &#xD;
            4. Bicuspid aortic valve anatomy&#xD;
  &#xD;
            5. Severely impaired left ventricular ejection fraction (LVEF &lt;35%)&#xD;
  &#xD;
            6. At least moderate mitral regurgitation&#xD;
  &#xD;
            7. Non-cardiac illness with a life expectancy of less than 1 year&#xD;
  &#xD;
            8. Currently participating in another trial before reaching first endpoint.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>83 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Roberto Nerla, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Maria Cecilia Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Roberto Nerla, MD</last_name>
      <phone>0545/217446</phone>
      <phone_ext>+39</phone_ext>
      <email>rnerla@gvmnet.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fausto Castriota, MD</last_name>
      <phone>0545/217337</phone>
      <phone_ext>+39</phone_ext>
      <email>fcastriota@gvmnet.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maria Cecilia Hospital</name>
        <address>
          <city>Cotignola</city>
          <state>Ravenna</state>
          <zip>48033</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roberto Nerla, MD</last_name>
        <phone>0545/217446</phone>
        <phone_ext>+39</phone_ext>
        <email>rnerla@gvmnet.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 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>
  
  
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/NCT05983458
  org study id: SAFARI
  nct id: NCT05983458
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Recent evidence from scientific literature supported the extension of TAVI procedures to
        lower risk populations. Despite its widespread usage, the expansion of TAVI into lower risk
        patient populations is still limited by complications and costs, with a large disparity
        between clinical trials and real-world scenarios suggesting still long hospitalizations after
        TAVI. This issue has got relevant implications in cost-effectiveness of the procedure, with
        many studies showing a more favourable cost profile associated with early discharges
  In most cases, prolongation of hospital stay is mainly related to electrical, renal, vascular
        or neurological complications. With increasing operators' experience, careful procedure
        planning and technology improvement, procedure-related complications are reducing, with
        favourable effects in terms of postprocedural length-of-stay and related costs.
  
        This is particularly true for lower risk populations. Being surgery the gold standard for
        treating aortic valve disease in low-risk patients, the outcomes after TAVI in this
        population should meet high standards to be accepted. In particular, optimal results should
        not be limited to procedural success but last over time, ensuring both a long-life expectancy
        and a good quality of life. TAVI efficacy in this population should include the absence of
        residual paravalvular leaks, no need for permanent pacemakers, no cerebral embolism and the
        opportunity of easily re-accessing coronary arteries in the future. In particular, many
        questions have been raised about the difficulty of coronary re-access following use of the
        EvolutR/PRO valves compared to the Sapien 3 valves. Thus, valves with a larger open-celled
        design (ACURATE neo, Portico or JENA) are potentially more favourable for coronary access and
        could be considered in patients likely to require repeated re-access to coronary arteries.
  
        Acurate Neo Valve showed good procedural results in high-risk subsets of patients. Although
        not tested in large-scale trials involving low risk patients, due to its unique morphology it
        could offer peculiar advantages, compared to other devices, including:
  
          1. Low permanent pacemaker rates
  
          2. Easier coronary re-access
  
          3. Low paravalvular leak rate (novel Neo 2 technology) The aim of this study was to report
             on the feasibility and safety of early discharge (defined as discharge within 48 hours
             from the procedure) of selected low-risk patients after transfemoral TAVI with the novel
             Acurate Neo2 valve platform
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: safety and efficacy of a standardized rapid discharge protocol in low-risk patients treated with the TAVI procedure and the Acurate Neo 2 valve
  time frame: 12 months
  description: • Freedom from mortality
  arm group label: patients with severe symptomatic aortic stenosis
  arm group type: Other
  description: Real-world patients with severe symptomatic aortic stenosis allocated to TAVI treatment by local heart Team will be included in the study according to the inclusion and exclusion criteria specified below.
  intervention type: Procedure
  intervention name: Transaortic valve replacement
  description: TAVI procedure will be performed under conscious sedation. Foley urinary catheters and jugular lines will be avoided.
  For femoral access, closure devices will be Prostar or ProGlide, which are similar and carry low rates of major vascular complications . Single femoral access and a radial access as the secondary arterial access will be used to reduce the rate of vascular complications.
  All procedures will be performed with cerebral protection using the Sentinel device. During valve implantation, commissural alignment will be checked for all patients. As a practical rule, commissural alignment will be checked in co-planar view and in cusp-overlap view.
  arm group label: patients with severe symptomatic aortic stenosis
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 83 Years
  healthy volunteers: No
  last name: Roberto Nerla, MD
  role: Principal Investigator
  affiliation: Maria Cecilia Hospital
  last name: Roberto Nerla, MD
  phone: 0545/217446
  phone ext: +39
  email: rnerla@gvmnet.it
  last name: Fausto Castriota, MD
  phone: 0545/217337
  phone ext: +39
  email: fcastriota@gvmnet.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Aortic Valve Stenosis
  sharing ipd: No