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/NCT05978466</url>
    </required_header>
    <id_info>
      <org_study_id>2017-CSF-00100</org_study_id>
      <nct_id>NCT05978466</nct_id>
    </id_info>
    <brief_title>MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)</brief_title>
    <acronym>MANAGE-AF</acronym>
    <official_title>MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CorVita Science Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CorVita Science Foundation</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 this research is to learn more about the normal care of patients with a new or&#xD;
        pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats&#xD;
        place patients at increased risk of developing clots in their bloodstream that could&#xD;
        potentially lead to stroke. Normal care is designed to help prevent this from happening and&#xD;
        to lessen or eliminate the symptoms patients may have. There are many different types of AF&#xD;
        as well as numerous ways in which a variety of patients are treated. The investigators are&#xD;
        interested in gathering more information to better keep track of patient treatment patterns&#xD;
        (trends) that may differ from physician to physician, hospital to hospital, medication to&#xD;
        medication, patient to patient and if necessary, procedure to procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The objective of this research is to establish a contemporary and simple to construct AF&#xD;
        management registry that expands progressively over the continuum of care for each individual&#xD;
        patient. The registry will be used to determine the course and progression of AF management&#xD;
        in preventing thrombo-embolic events using rhythm and rate control interventions.&#xD;
  &#xD;
        Primary endpoints:&#xD;
  &#xD;
          1. Atrial fibrillation natural history&#xD;
  &#xD;
          2. Thrombo-embolic event&#xD;
  &#xD;
          3. Death&#xD;
  &#xD;
        Secondary endpoints:&#xD;
  &#xD;
          1. Bleeding&#xD;
  &#xD;
          2. Pro-arrhythmia&#xD;
  &#xD;
          3. Patient adherence&#xD;
  &#xD;
          4. Treatment complication&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 22, 2017</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence of Atrial fibrillation</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>The natural progression of the condition will be assessed per medical record review</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Thrombo-embolic event</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>All strokes, transient ischemic and systemic thrombo-embolic events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mortality</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>All cause death will be noted</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bleeding</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>All bleeding events events will be will be assessed throughout the duration of the study per medical record review</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pro-arrhythmia</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>All pro-arrhythmic events will be documented and assessed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient adherence</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment complication</measure>
      <time_frame>From enrollment to 10- year study completion</time_frame>
      <description>All adverse outcomes/events related to routine standard of care treatments will be noted and assessed for the duration of the study per medical record review</description>
    </secondary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Atrial Fibrillation</condition>
    <eligibility>
      <study_pop>
        <textblock>
          All subjects with the diagnosis of atrial fibrillation can be enrolled into the study&#xD;
          regardless of sex, age or medical history&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of valvular or non valvular atrial fibrillation&#xD;
  &#xD;
            2. ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D.&#xD;
               Holter Monitor E. Implantable loop recorder&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Age below 18 years.&#xD;
  &#xD;
            2. Clinical evidence that death within 6 months is possible&#xD;
  &#xD;
            3. Inability to consent to the research or sign a consent form&#xD;
  &#xD;
            4. Inability to follow up at the research clinic at least annually for continuity of AF&#xD;
               care and management&#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>Martin C Burke, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chief Scientific Officer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Edward M Burke</last_name>
      <phone>773-432-4888</phone>
      <email>eddie@corvitahealth.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Martin C Burke, DO</last_name>
      <phone>773-432-4888</phone>
      <email>mburke@corvitahealth.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CorVita Science Foundation (NFP)</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60605</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Edward Burke</last_name>
        <phone>773-432-4888</phone>
        <email>eddie@corvitahealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Martin C Burke, DO</last_name>
        <phone>773-432-4888</phone>
        <email>mburke@corvitahealth.org</email>
      </contact_backup>
      <investigator>
        <last_name>Martin C Burke, DO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.corvitascience.org</url>
      <description>Research foundation's website</description>
    </link>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>April 11, 2019</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>atrial arrhythmia</keyword>
    <keyword>atrial fibrillation</keyword>
    <keyword>stroke</keyword>
    <keyword>bleeding</keyword>
    <keyword>Left Atrial Appendage Occlusion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Intermittently over the next 10-15 years</ipd_time_frame>
      <ipd_access_criteria>Co-investigator who enrolls at least one patient</ipd_access_criteria>
      <ipd_url>http://www.corvitascience.org</ipd_url>
    </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/NCT05978466
  org study id: 2017-CSF-00100
  nct id: NCT05978466
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to learn more about the normal care of patients with a new or
        pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats
        place patients at increased risk of developing clots in their bloodstream that could
        potentially lead to stroke. Normal care is designed to help prevent this from happening and
        to lessen or eliminate the symptoms patients may have. There are many different types of AF
        as well as numerous ways in which a variety of patients are treated. The investigators are
        interested in gathering more information to better keep track of patient treatment patterns
        (trends) that may differ from physician to physician, hospital to hospital, medication to
        medication, patient to patient and if necessary, procedure to procedure.
  The objective of this research is to establish a contemporary and simple to construct AF
        management registry that expands progressively over the continuum of care for each individual
        patient. The registry will be used to determine the course and progression of AF management
        in preventing thrombo-embolic events using rhythm and rate control interventions.
  
        Primary endpoints:
  
          1. Atrial fibrillation natural history
  
          2. Thrombo-embolic event
  
          3. Death
  
        Secondary endpoints:
  
          1. Bleeding
  
          2. Pro-arrhythmia
  
          3. Patient adherence
  
          4. Treatment complication
  observational model: Case-Only
  time perspective: Cross-Sectional
  measure: Recurrence of Atrial fibrillation
  time frame: From enrollment to 10- year study completion
  description: The natural progression of the condition will be assessed per medical record review
  measure: Thrombo-embolic event
  time frame: From enrollment to 10- year study completion
  description: All strokes, transient ischemic and systemic thrombo-embolic events
  measure: Mortality
  time frame: From enrollment to 10- year study completion
  description: All cause death will be noted
  measure: Bleeding
  time frame: From enrollment to 10- year study completion
  description: All bleeding events events will be will be assessed throughout the duration of the study per medical record review
  measure: Pro-arrhythmia
  time frame: From enrollment to 10- year study completion
  description: All pro-arrhythmic events will be documented and assessed
  measure: Patient adherence
  time frame: From enrollment to 10- year study completion
  description: Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review
  measure: Treatment complication
  time frame: From enrollment to 10- year study completion
  description: All adverse outcomes/events related to routine standard of care treatments will be noted and assessed for the duration of the study per medical record review
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Martin C Burke, DO
  role: Principal Investigator
  affiliation: Chief Scientific Officer
  last name: Edward M Burke
  phone: 773-432-4888
  email: eddie@corvitahealth.org
  last name: Martin C Burke, DO
  phone: 773-432-4888
  email: mburke@corvitahealth.org
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: http://www.corvitascience.org
  description: Research foundation's website
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: Yes
  ipd description: We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Intermittently over the next 10-15 years
  ipd access criteria: Co-investigator who enrolls at least one patient
  ipd url: http://www.corvitascience.org