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/NCT06026345</url>
    </required_header>
    <id_info>
      <org_study_id>Affera Global Registry</org_study_id>
      <nct_id>NCT06026345</nct_id>
    </id_info>
    <brief_title>Affera Global Registry</brief_title>
    <official_title>The Affera Global Registry is a Prospective, Global, Multi-center, Observational Post-market Registry (PMR)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medtronic Cardiac Rhythm and Heart Failure</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Affera Global Registry is a prospective, global, multi-center, observational post-market&#xD;
        registry (PMR). The purpose of this study is to describe clinical performance and safety data&#xD;
        in a broad patient population treated with the Affera Platform.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 6, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2028</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>2 Years</target_duration>
    <primary_outcome>
      <measure>Primary Objective #1 (Efficacy)</measure>
      <time_frame>12 Month Post Proceedure</time_frame>
      <description>Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Primary Objective #2 (Safety)</measure>
      <time_frame>90 Days Post Proceedure</time_frame>
      <description>Estimate serious device and serious procedure-related adverse events for the Affera Platform.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Treatment Arm</arm_group_label>
      <description>Patients enrolled and treated with the Affera Platform</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Affera Platform</intervention_name>
      <description>A cardiac ablation will be performed using the Affera Platform</description>
      <arm_group_label>Treatment Arm</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects ≥ 18 years of age (or minimum age as required by local regulations) who have a&#xD;
          recommendation for an ablation with the Affera Platform may be approached regarding&#xD;
          enrollment in this study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is ≥ 18 years of age or minimum age as required by local regulations&#xD;
  &#xD;
            -  Planned procedure using the commercially available Affera Platform&#xD;
  &#xD;
            -  Willing and able to comply with study requirements and give IC (defined as legally&#xD;
               effective, documented confirmation of a subject's voluntary agreement to participate&#xD;
               in this clinical study) or authorization per institution and geographical requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject is enrolled in a concurrent study that has not been approved for concurrent&#xD;
               enrollment by the global study manager&#xD;
  &#xD;
            -  Subject with exclusion criteria required by local law&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ryan Radtke</last_name>
      <phone>+17129419372</phone>
      <email>ryan.s.radtke@medtronic.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Susan Knols</last_name>
      <phone>susan.knols@medtronic.com</phone>
      <email>susan.knols@medtronic.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <!-- 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/NCT06026345
  org study id: Affera Global Registry
  nct id: NCT06026345
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  The Affera Global Registry is a prospective, global, multi-center, observational post-market
        registry (PMR). The purpose of this study is to describe clinical performance and safety data
        in a broad patient population treated with the Affera Platform.
  observational model: Cohort
  time perspective: Prospective
  measure: Primary Objective #1 (Efficacy)
  time frame: 12 Month Post Proceedure
  description: Estimate freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the Affera Platform.
  measure: Primary Objective #2 (Safety)
  time frame: 90 Days Post Proceedure
  description: Estimate serious device and serious procedure-related adverse events for the Affera Platform.
  arm group label: Treatment Arm
  description: Patients enrolled and treated with the Affera Platform
  intervention type: Device
  intervention name: Affera Platform
  description: A cardiac ablation will be performed using the Affera Platform
  arm group label: Treatment Arm
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ryan Radtke
  phone: +17129419372
  email: ryan.s.radtke@medtronic.com
  last name: Susan Knols
  phone: susan.knols@medtronic.com
  email: susan.knols@medtronic.com
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation