<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/NCT01723566</url>
  </required_header>
  <id_info>
    <org_study_id>PANORAMA 2</org_study_id>
    <nct_id>NCT01723566</nct_id>
  </id_info>
  <brief_title>PANORAMA 2 Observational Study</brief_title>
  <official_title>Panorama 2 Medtronic CRDM Implantable Cardiac Device Long Term Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Bakken Research Center</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Bakken Research Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Understanding the clinical practice of treatment of cardiac rhythm disorders all over the&#xD;
      world and understanding the clinical outcomes of the treatment with its cardiac rhythm&#xD;
      products in real world patient population is essential for Medtronic to be able to&#xD;
      effectively develop new products and adjust existing products. In addition Medtronic is&#xD;
      committed to monitor the safety of its products throughout the entire life cycle to ensure&#xD;
      maximum product reliability.&#xD;
&#xD;
      The Panorama 2 registry will enable Medtronic to increase data collection of clinical&#xD;
      practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in&#xD;
      various regions across the world and on product reliability of its CRDM devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2012</start_date>
  <completion_date type="Actual">October 31, 2016</completion_date>
  <primary_completion_date type="Actual">October 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Describe region-specific clinical practice of CRDM device use</measure>
    <time_frame>2012-2019</time_frame>
    <description>To describe the region-specific current clinical practices associated with the device treatment of patients receiving implantable Medtronic CRDM devices by collecting information on the patient characteristics (demographics, medical history and cardiovascular status), the type of Medtronic CRDM devices used, the indication for the use of the Medtronic CRDM devices and the clinical outcomes of the treatment with the Medtronic CRDM devices (all deaths, cardiovascular hospitalizations, Serious Adverse Device Effects and NYHA class).</description>
  </primary_outcome>
  <enrollment type="Actual">4706</enrollment>
  <condition>Heart Rhythm Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients that have a Medtronic implantable CRDM Device implanted (including Vitatron),&#xD;
        which is commercially available at the start of the registry or becomes commercially&#xD;
        available during the course of the registry, and used within its intended use, may be&#xD;
        included.&#xD;
&#xD;
        These products are:&#xD;
&#xD;
          -  Pacemaker systems: Implantable Pulse Generators (IPG) and cardiac leads&#xD;
&#xD;
          -  Defibrillation systems: Implantable Cardioverter Defibrillators (ICD) and cardiac&#xD;
             leads&#xD;
&#xD;
          -  Resynchronization systems: Cardiac Resynchronization Therapy (CRT):&#xD;
&#xD;
               -  Cardiac Resynchronization Therapy - Pacemaker (CRT-P) and cardiac leads&#xD;
&#xD;
               -  Cardiac Resynchronization Therapy - Defibrillator (CRT-D) and cardiac leads&#xD;
&#xD;
          -  Implantable Loop Recorders (ILR)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patient is 18 years of age or older (lower age limit dependent on local law: to be&#xD;
             specified in country-specific addendum to the clinical investigational plan, if&#xD;
             applicable)&#xD;
&#xD;
          -  Patient or Legally Authorized Representative provides signed and dated authorization&#xD;
             and/or consent per institution and local requirements&#xD;
&#xD;
          -  Patient will be treated with a commercially available implantable Medtronic CRDM&#xD;
             device/ Vitatron device within maximally 30 days after enrollment or within 3 days&#xD;
             prior to enrollment&#xD;
&#xD;
        Exclusion criterion:&#xD;
&#xD;
        • Patient has exclusion criteria per local law (to be specified in country-specific&#xD;
        addendum to the clinical investigational plan, if applicable)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 8, 2012</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</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>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <!-- 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/NCT01723566
org study id: PANORAMA 2
nct id: NCT01723566
lead sponsor: 
has dmc: No
Understanding the clinical practice of treatment of cardiac rhythm disorders all over the
      world and understanding the clinical outcomes of the treatment with its cardiac rhythm
      products in real world patient population is essential for Medtronic to be able to
      effectively develop new products and adjust existing products. In addition Medtronic is
      committed to monitor the safety of its products throughout the entire life cycle to ensure
      maximum product reliability.

      The Panorama 2 registry will enable Medtronic to increase data collection of clinical
      practice with Medtronic implantable Cardiac Rhythm and Disease Management (CRDM) devices in
      various regions across the world and on product reliability of its CRDM devices.
observational model: Cohort
time perspective: Prospective
measure: Describe region-specific clinical practice of CRDM device use
time frame: 2012-2019
description: To describe the region-specific current clinical practices associated with the device treatment of patients receiving implantable Medtronic CRDM devices by collecting information on the patient characteristics (demographics, medical history and cardiovascular status), the type of Medtronic CRDM devices used, the indication for the use of the Medtronic CRDM devices and the clinical outcomes of the treatment with the Medtronic CRDM devices (all deaths, cardiovascular hospitalizations, Serious Adverse Device Effects and NYHA class).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac