<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/NCT01716143</url>
  </required_header>
  <id_info>
    <org_study_id>2011-SR-014</org_study_id>
    <nct_id>NCT01716143</nct_id>
  </id_info>
  <brief_title>Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation to Treat Chronic Atrial Fibrillation</brief_title>
  <official_title>Left Atrium Substrate Based Ablation Plus Circumferential Pulmonary Vein Isolation in the Treatment of Persistent and Long-standing Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether left atrium substrate based ablation plus&#xD;
      circumferential is effective in the treatment of persistent and long-standing atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2010</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure.</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation</measure>
    <time_frame>December 31, 2012</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">87</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>catheter ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>radiofrequency catheter ablation</intervention_name>
    <arm_group_label>catheter ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All persistent or permanent AF patients with refractory or intolerant to at least one Class&#xD;
        1 or Class 3 antiarrhythmic medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with paroxysmal AF (self-terminating episodes lasting &lt; 7 day)&#xD;
&#xD;
          2. Patients who have had a previous AF ablation procedure&#xD;
&#xD;
          3. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Minglong Chen, MD</last_name>
    <phone>0086-25-6813-6965</phone>
    <email>chenminglong@njmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Division of Cardiology, the First Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Minglong Chen, MD</last_name>
      <phone>0086-25-68136965</phone>
      <email>chenminglong@njmu.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Minglong Chen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Youquan Wei</investigator_full_name>
    <investigator_title>Clinical Investigator</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>catheter ablation</keyword>
  <keyword>Mapping</keyword>
  <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/NCT01716143
org study id: 2011-SR-014
nct id: NCT01716143
lead sponsor: 
The purpose of this study is to determine whether left atrium substrate based ablation plus
      circumferential is effective in the treatment of persistent and long-standing atrial
      fibrillation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary study end point was freedom from atrial arrhythmias off antiarrhythmic drugs at 3,6,12,18 and 24 months after a single-ablation. procedure.
time frame: 3 years
measure: The percentage of macro-reentrant atrial tachycardia in recurrent arrhythmias after atrial fibrillation ablation
time frame: December 31, 2012
arm group label: catheter ablation
arm group type: Other
intervention type: Procedure
intervention name: radiofrequency catheter ablation
arm group label: catheter ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Minglong Chen, MD
phone: 0086-25-6813-6965
email: chenminglong@njmu.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Youquan Wei
investigator title: Clinical Investigator
mesh term: Atrial Fibrillation