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/NCT05974306</url>
    </required_header>
    <id_info>
      <org_study_id>v.2.0 29 mar23</org_study_id>
      <nct_id>NCT05974306</nct_id>
    </id_info>
    <brief_title>Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System</brief_title>
    <acronym>VASCO</acronym>
    <official_title>Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System: a Prospective Randomized Clinical Trial (VASCO)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leonardo Calò, MD</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Policlinico Casilino ASL RMB</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>
        Vasco trial is a no profit, multicenter, international, prospective, randomized study&#xD;
        designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs&#xD;
        standard practice in patients with high risk of cardiac arrhythmias, heart failure and left&#xD;
        ventricle ejection fraction (LVEF)&gt; 40% .The study will enroll about 331 patients (221 in the&#xD;
        ILR group and 110 in the in-hospital follow-up group).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</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>Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF&gt; 40% in the detection of significant clinical events.</measure>
      <time_frame>2 years</time_frame>
      <description>Detection rate of arrhythmias that require treatment (medical or interventional)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">331</enrollment>
    <condition>Heart Failure</condition>
    <condition>Arrhythmias, Cardiac</condition>
    <arm_group>
      <arm_group_label>ILR group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients implanted with an implantable loop recorder to be monitored remotely.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>in-hospital fup group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients that will be followed with in-hospital visits.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>implantable loop recorder</intervention_name>
      <description>Implantation of an implantable loop recorder</description>
      <arm_group_label>ILR group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with heart failure, LVEF&gt; 40% who report episodes of palpitations.&#xD;
  &#xD;
            -  Over 18 years of age&#xD;
  &#xD;
            -  Ability to provide informed consent for registry participation and be willing and able&#xD;
               to comply with the protocol described evaluations&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject who is, or is expected to be unavailable for follow-up&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Medical contraindications for ILR implantation&#xD;
  &#xD;
            -  Patients with PMK / ICD or with Indication for ICD / PMK implantation&#xD;
  &#xD;
            -  Cardiovascular events / myocardial revascularization in the previous three months&#xD;
  &#xD;
            -  Patients already on oral anticoagulant treatment&#xD;
  &#xD;
            -  Patients who do not want to use the telemonitoring system&#xD;
  &#xD;
            -  Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic&#xD;
               stroke/TIA, Transient loss of consciousness and recurrent falls)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Policlinico Casilino ASL RMB</investigator_affiliation>
      <investigator_full_name>Leonardo Calò, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</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/NCT05974306
  org study id: v.2.0 29 mar23
  nct id: NCT05974306
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Vasco trial is a no profit, multicenter, international, prospective, randomized study
        designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs
        standard practice in patients with high risk of cardiac arrhythmias, heart failure and left
        ventricle ejection fraction (LVEF)> 40% .The study will enroll about 331 patients (221 in the
        ILR group and 110 in the in-hospital follow-up group).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF> 40% in the detection of significant clinical events.
  time frame: 2 years
  description: Detection rate of arrhythmias that require treatment (medical or interventional)
  arm group label: ILR group
  arm group type: Experimental
  description: patients implanted with an implantable loop recorder to be monitored remotely.
  arm group label: in-hospital fup group
  arm group type: No Intervention
  description: Patients that will be followed with in-hospital visits.
  intervention type: Device
  intervention name: implantable loop recorder
  description: Implantation of an implantable loop recorder
  arm group label: ILR group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  responsible party type: Sponsor-Investigator
  investigator affiliation: Policlinico Casilino ASL RMB
  investigator full name: Leonardo Calò, MD
  investigator title: Principal Investigator
  mesh term: Heart Failure
  mesh term: Arrhythmias, Cardiac
  sharing ipd: No