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/NCT06019845</url>
    </required_header>
    <id_info>
      <org_study_id>MFEAS-001</org_study_id>
      <nct_id>NCT06019845</nct_id>
    </id_info>
    <brief_title>The MAGiC™ Cardiac Ablation European Study</brief_title>
    <acronym>MAGiC-FEST</acronym>
    <official_title>The MAGiC™ Cardiac Ablation Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stereotaxis</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Osypka AG</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stereotaxis</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>
        The purpose of the first phase of this feasibility study is to gather safety and performance&#xD;
        data on MAGiC to support European marketing approval. After MAGiC obtains European approval,&#xD;
        the study will be amended and expanded to collect Post-Market Clinical Follow-up data.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">January 2026</completion_date>
    <primary_completion_date type="Anticipated">June 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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Acute Performance</measure>
      <time_frame>hospital discharge - up to 7 days post procedure</time_frame>
      <description>The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acute Safety</measure>
      <time_frame>hospital discharge - up to 7 days post procedure</time_frame>
      <description>Freedom from major adverse events (MAE) related to MAGiC.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Chronic Success</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety Events</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Onset of Procedure-related New Arrhythmia</measure>
      <time_frame>3 months, 6 months, 12 months</time_frame>
      <description>Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Arrhythmias, Cardiac</condition>
    <arm_group>
      <arm_group_label>Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Magnetic Interventional Ablation Catheter (MAGiC™)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MAGiC™</intervention_name>
      <description>Robotic magnetic radiofrequency (RF) ablation catheter</description>
      <arm_group_label>Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (aged 18 or older at time of consent);&#xD;
  &#xD;
            -  Eligible for ablation procedures of an atrial or ventricular arrhythmia per European&#xD;
               Heart Rhythm Association (EHRA) guidelines, with at least one (1) documented episode&#xD;
               of the tachyarrhythmia to be treated within the previous six (6) months;&#xD;
  &#xD;
            -  Able to be safely exposed to magnetic fields;&#xD;
  &#xD;
            -  Willing and capable to attend scheduled follow up visits at the investigational site&#xD;
               for the study duration (up to 12 months)&#xD;
  &#xD;
            -  Willing and able to provide informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to be safely exposed to magnetic fields due to Magnetic Resonance Imaging&#xD;
               Unsafe device (implanted device or device that cannot be safely removed for the&#xD;
               procedure)&#xD;
  &#xD;
            -  Unable to remain comfortable or hemodynamically stable in the supine position for an&#xD;
               extended period of time&#xD;
  &#xD;
            -  Weight exceeding 200 kg (the weight limit of the table)&#xD;
  &#xD;
            -  For female patients of childbearing potential: pregnancy at the time of the procedure&#xD;
               or unwilling to take a pregnancy test&#xD;
  &#xD;
            -  Presence of intracardiac thrombus at the time of the procedure&#xD;
  &#xD;
            -  Where MAGiC would need to cross a prosthetic valve&#xD;
  &#xD;
            -  Use of MAGiC in the coronary arteries&#xD;
  &#xD;
            -  A history of sensitivity to foreign objects or extreme allergies&#xD;
  &#xD;
            -  Acute illness or active systemic infection&#xD;
  &#xD;
            -  Histological or anatomical abnormalities that may lead to post-operative complications&#xD;
               including diminished resistance to infection&#xD;
  &#xD;
            -  Hemodynamic instability&#xD;
  &#xD;
            -  Unable to receive heparin or an acceptable alternative to achieve adequate&#xD;
               anticoagulation&#xD;
  &#xD;
            -  Acute myocardial infarct (within the previous 30 days)&#xD;
  &#xD;
            -  Recent cardiac surgery (within the previous 60 days)&#xD;
  &#xD;
            -  Unstable angina&#xD;
  &#xD;
            -  History of embolism (cerebrovascular accident, transient ischemic attack, systemic&#xD;
               embolism) in the previous 30 days&#xD;
  &#xD;
            -  Previous cardiac ablation within the previous 30 days&#xD;
  &#xD;
            -  Concomitant arrhythmia(s) requiring active treatment at this time or in the 90 days&#xD;
               prior to enrollment (Day -90 to Day 0)&#xD;
  &#xD;
            -  Currently or in the 30 days prior to consent, participation in an interventional&#xD;
               clinical trial&#xD;
  &#xD;
            -  Significant uncontrolled or unstable medical problems which, in the opinion of the&#xD;
               Investigator, would preclude enrollment in and completion of the study (limitation on&#xD;
               survival).&#xD;
  &#xD;
            -  Any reason or condition that, in the judgement of the investigator, makes the patient&#xD;
               ineligible for the investigation.&#xD;
  &#xD;
            -  For Atrial Fibrillation only: persistent Atrial Fibrillation (continuous Atrial&#xD;
               Fibrillation lasting longer than 7 days)&#xD;
  &#xD;
            -  For Atrial Fibrillation only: Presence of any device that would interfere with planned&#xD;
               access: Patent Foramen Ovale occlusion/closure device, patch&#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_official>
      <last_name>Stephanie Buech</last_name>
      <role>Study Director</role>
      <affiliation>Stereotaxis</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stephanie Buech</last_name>
      <phone>314-678-6100</phone>
      <email>stephanie.buech@stereotaxis.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ioana Gruchevska</last_name>
      <phone>314-678-6217</phone>
      <email>ioana.gruchevska@stereotaxis.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Atrial Fibrillation</keyword>
    <keyword>Atrial Flutter</keyword>
    <keyword>Ventricular Tachycardia</keyword>
    <keyword>Supraventricular Tachycardia</keyword>
    <keyword>Ablation</keyword>
    <keyword>Premature Ventricular Contractions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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/NCT06019845
  org study id: MFEAS-001
  nct id: NCT06019845
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the first phase of this feasibility study is to gather safety and performance
        data on MAGiC to support European marketing approval. After MAGiC obtains European approval,
        the study will be amended and expanded to collect Post-Market Clinical Follow-up data.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Acute Performance
  time frame: hospital discharge - up to 7 days post procedure
  description: The primary endpoint is to estimate the acute procedural success across a range of treated arrhythmias.
  measure: Acute Safety
  time frame: hospital discharge - up to 7 days post procedure
  description: Freedom from major adverse events (MAE) related to MAGiC.
  measure: Chronic Success
  time frame: 3 months, 6 months, 12 months
  description: Percentage of subjects free from the treated index arrhythmia at the relevant chronic timepoint.
  measure: Safety Events
  time frame: 3 months, 6 months, 12 months
  description: Rate of subjects experiencing investigational device-related adverse events and procedure-related adverse events.
  measure: Onset of Procedure-related New Arrhythmia
  time frame: 3 months, 6 months, 12 months
  description: Percentage of subjects who experience the onset of a new arrhythmia related to the index procedure.
  arm group label: Treatment
  arm group type: Experimental
  description: Magnetic Interventional Ablation Catheter (MAGiC™)
  intervention type: Device
  intervention name: MAGiC™
  description: Robotic magnetic radiofrequency (RF) ablation catheter
  arm group label: Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stephanie Buech
  role: Study Director
  affiliation: Stereotaxis
  last name: Stephanie Buech
  phone: 314-678-6100
  email: stephanie.buech@stereotaxis.com
  last name: Ioana Gruchevska
  phone: 314-678-6217
  email: ioana.gruchevska@stereotaxis.com
  responsible party type: Sponsor
  mesh term: Arrhythmias, Cardiac
  sharing ipd: No