<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/NCT03041233</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10192</org_study_id>
    <nct_id>NCT03041233</nct_id>
  </id_info>
  <brief_title>ABLATOR Brazil - Ablation Observational Study (Registry)</brief_title>
  <official_title>ABLATOR Brazil - Ablation Observational Study (Registry)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</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 registry is to assess the performance and clinical effectiveness of a&#xD;
      combination of SJM mapping and ablation products in the treatment of subjects with atrial&#xD;
      fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objectives of this registry are the following:&#xD;
&#xD;
        -  To confirm patient safety as part of the post market surveillance study.&#xD;
&#xD;
        -  To assess performance of a combination of SJM products during procedures.&#xD;
&#xD;
        -  To assess the learning curve with a combination of SJM products.&#xD;
&#xD;
        -  To collect operator feedback on a combination of SJM products.&#xD;
&#xD;
      All patients from participating sites who are indicated for an atrial fibrillation ablation&#xD;
      procedure and willing to provide written Informed Consent may be enrolled in this registry.&#xD;
&#xD;
      In order to ensure a minimum level of uniformity across site practices and to enable&#xD;
      comparison of acute and long-term effectiveness as well as procedure efficiency according to&#xD;
      technique used, a combination of 2 types of devices from the pre-specified list must be used&#xD;
      to be eligible in this registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 13, 2017</start_date>
  <completion_date type="Anticipated">April 27, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 27, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Unsuccessful treatment rate, measured by the number of repeated procedure</measure>
    <time_frame>within 12 months after ablation procedure</time_frame>
    <description>measured by the number of repeated procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Serious Adverse Event</measure>
    <time_frame>within 12 months after ablation procedure</time_frame>
    <description>Reporting of SAE through the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>within 12 months after ablation procedure</time_frame>
    <description>Reporting of death through the CRF</description>
  </secondary_outcome>
  <enrollment type="Actual">833</enrollment>
  <condition>Atrial Fibrillation</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation / Data Collection</intervention_name>
    <description>The following data will be reviewed / collected:&#xD;
BASELINE VISIT: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history.&#xD;
ABLATION PROCEDURE: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence).&#xD;
6 and 12 MONTH FOLLOW-UP (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients who are indicated for an atrial fibrillation ablation procedure, except for&#xD;
        pregnant women.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who are indicated for an atrial fibrillation ablation procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#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>André Luiz D'Avila</last_name>
    <role>Principal Investigator</role>
    <affiliation>SOS Cardio</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Santa Casa de Misericórdia da Bahia</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40050-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardioritmo Eletrofisiologia e Marpasso</name>
      <address>
        <city>Fortaleza</city>
        <state>CE</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOME - Hospital Ortopédico e Medicina Especializada LTDA.</name>
      <address>
        <city>Brasília</city>
        <state>DF</state>
        <zip>70200730</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Rita</name>
      <address>
        <city>Vitória</city>
        <state>ES</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vitoria Apart Hotel</name>
      <address>
        <city>Vitória</city>
        <state>ES</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Procardiaco</name>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unimed de Volta Redonda</name>
      <address>
        <city>Volta Redonda</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Vicente de Paulo</name>
      <address>
        <city>Passo Fundo</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SOS Cardio</name>
      <address>
        <city>Florianopolis</city>
        <state>SC</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Insitituto de Moléstias Cardiovasculares - IMC</name>
      <address>
        <city>São José do Rio Prêto</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SEMAP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2019</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 12, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03041233
org study id: SJM-CIP-10192
nct id: NCT03041233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this registry is to assess the performance and clinical effectiveness of a
      combination of SJM mapping and ablation products in the treatment of subjects with atrial
      fibrillation (AF).
The objectives of this registry are the following:

        -  To confirm patient safety as part of the post market surveillance study.

        -  To assess performance of a combination of SJM products during procedures.

        -  To assess the learning curve with a combination of SJM products.

        -  To collect operator feedback on a combination of SJM products.

      All patients from participating sites who are indicated for an atrial fibrillation ablation
      procedure and willing to provide written Informed Consent may be enrolled in this registry.

      In order to ensure a minimum level of uniformity across site practices and to enable
      comparison of acute and long-term effectiveness as well as procedure efficiency according to
      technique used, a combination of 2 types of devices from the pre-specified list must be used
      to be eligible in this registry.
observational model: Case-Only
time perspective: Prospective
measure: Unsuccessful treatment rate, measured by the number of repeated procedure
time frame: within 12 months after ablation procedure
description: measured by the number of repeated procedure
measure: Cardiovascular Serious Adverse Event
time frame: within 12 months after ablation procedure
description: Reporting of SAE through the CRF
measure: Death
time frame: within 12 months after ablation procedure
description: Reporting of death through the CRF
intervention type: Other
intervention name: Observation / Data Collection
description: The following data will be reviewed / collected:
BASELINE VISIT: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history.
ABLATION PROCEDURE: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence).
6 and 12 MONTH FOLLOW-UP (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: André Luiz D'Avila
role: Principal Investigator
affiliation: SOS Cardio
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Undecided
submitted: June 12, 2023