<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/NCT03040037</url>
  </required_header>
  <id_info>
    <org_study_id>PRAF-CA</org_study_id>
    <nct_id>NCT03040037</nct_id>
  </id_info>
  <brief_title>Cryoballoon Atrial Fibrillation Ablation Registry</brief_title>
  <official_title>Prospective Registry of Atrial Fibrillation Cryoballoon Ablation in the Russian Federation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>RUSSIAN SOCIETY OF CARDIOLOGY</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health</source>
  <brief_summary>
    <textblock>
      This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation.&#xD;
      This study is observational, prospective, multicenter, open-label&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this Registry is to describe characteristics of patients undergoing&#xD;
      cryoballoon ablation, diversity of cryoablation techniques among different centers; to&#xD;
      evaluate efficacy and safety of the procedure in the centers with different levels of&#xD;
      experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">March 21, 2022</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</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>1 Year</target_duration>
  <primary_outcome>
    <measure>Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring</measure>
    <time_frame>1 Year</time_frame>
    <description>ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)</measure>
    <time_frame>Above parameters will be assessed only during the procedure of cryoablation</time_frame>
    <description>Data will be collected using a web-based system of electronic case report forms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with antiarrhythmic drug treatment at 12 months</measure>
    <time_frame>1 Year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">1100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult Patient with Indications for Catheter Ablation of Atrial Fibrillation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The indications for catheter ablation of atrial fibrillation&#xD;
&#xD;
          -  Signed informed consent to participate in the Register&#xD;
&#xD;
          -  Patients undergoing cryoballoon ablation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Left atrial thrombosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Federal State Budgetary Institution &quot;V. A. Almazov Federal North-West Medical Research Centre&quot; of the Ministry of Health of the Russian Federation</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197341</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2022</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>


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/NCT03040037
org study id: PRAF-CA
nct id: NCT03040037
lead sponsor: 
collaborator: 
This is a prospective registry of atrial fibrillation cryoablation in the Russian Federation.
      This study is observational, prospective, multicenter, open-label
The purpose of this Registry is to describe characteristics of patients undergoing
      cryoballoon ablation, diversity of cryoablation techniques among different centers; to
      evaluate efficacy and safety of the procedure in the centers with different levels of
      experience.
observational model: Cohort
time perspective: Prospective
measure: Freedom from arrhythmia: Number of participants with no evidence of atrial achyarrhythmia longer than 30 s, as detected by regular ECG monitoring
time frame: 1 Year
description: ECG monitoring will be performed in accordance with sites' routine practices (Holter monitoring every 3 months, implantable loop recorder, cardiac rhythm management device interrogation, other regular ECG screening)
measure: Number of participants with adverse events that are related to treatment (i.e. cardiac tamponade, periprocedural stroke, pulmonary vein stenosis, esophageal damage, etc)
time frame: 1 Year
measure: Number of participants with adverse events that are related to underlying disease (cardiovascular events not related to atrial fibrillation cryoablation)
time frame: 1 Year
measure: Atrial fibrillation procedure characteristics: Mean total ablation procedure time in minutes, mean fluoroscopy time in minutes (during the ablation procedure)
time frame: Above parameters will be assessed only during the procedure of cryoablation
description: Data will be collected using a web-based system of electronic case report forms
measure: Number of participants with antiarrhythmic drug treatment at 12 months
time frame: 1 Year
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Atrial Fibrillation