<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/NCT01686542</url>
  </required_header>
  <id_info>
    <org_study_id>SWAN-cpAF</org_study_id>
    <nct_id>NCT01686542</nct_id>
  </id_info>
  <brief_title>CPVI Plus Renal Sympathetic Modification Versus CPVI Alone for AF（Atrial Fibrillation） Ablation</brief_title>
  <official_title>Circumferential Pulmonary Vein Isolation (CPVI) Plus Renal Sympathetic Modification Versus CPVI Alone for AF Ablation: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed as a randomized control trial. The purpose of this study is to observe&#xD;
      the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary&#xD;
      vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Basic studies suggested that sympathetic nerves over-activity played an important role in the&#xD;
      pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a&#xD;
      new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation&#xD;
      (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to&#xD;
      evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial&#xD;
      fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients&#xD;
      randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration&#xD;
      of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting&#xD;
      more than 30 seconds, the incidence of composite cardiovascular events after renal&#xD;
      sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI&#xD;
      alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2012</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The relapse rate of atrial tachyarrhythmia</measure>
    <time_frame>Four years</time_frame>
    <description>Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>CPVI+RSM group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CPVI group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Circumferential pulmonary vein isolation is done alone for atrial fibrillation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPVI plus renal sympathetic modification</intervention_name>
    <description>CPVI plus renal denervation to reduce atrial arrhythmia recurrence.</description>
    <arm_group_label>CPVI+RSM group</arm_group_label>
    <other_name>Circumferential pulmonary vein isolation (CPVI)</other_name>
    <other_name>renal denervation</other_name>
    <other_name>renal ablation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CPVI</intervention_name>
    <description>CPVI alone to reduce atrial arrhythmia recurrence.</description>
    <arm_group_label>CPVI group</arm_group_label>
    <other_name>circumferential pulmonary vein ablation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • ≥ 18 years old, and ≤ 75 years old of age&#xD;
&#xD;
               -  more than half a year history of atrial fibrillation, no matter paroxysmal or&#xD;
                  persistent, with clinical symptom or ECG proved&#xD;
&#xD;
               -  be ineffective to at least one kind of anti-arrhythmic drugs treatment&#xD;
&#xD;
               -  echocardiography has done to except structural heart diseases such as congenital,&#xD;
                  valvular heart diseases and kinds of cardiomyopathy&#xD;
&#xD;
               -  estimated glomerular filtration rate (eGFR) of ≥ 45ml/min&#xD;
&#xD;
               -  is competent and willing to provide written, informed consent to participate in&#xD;
                  this clinical study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • transesophageal echocardiography found thrombus in left atrial appendage&#xD;
&#xD;
               -  past history of atrial fibrillation surgical maze procedure&#xD;
&#xD;
               -  estimated glomerular filtration rate (eGFR) of &lt; 45mL/min&#xD;
&#xD;
               -  has the history of renal restenosis or renal stents implantation&#xD;
&#xD;
               -  has experienced AMI（acute myocardial infarction） (old myocardial infarction is&#xD;
                  not excluded), unstable angina pectoris, cerebrovascular accidents, and&#xD;
                  alimentary tract hemorrhage within 3 months&#xD;
&#xD;
               -  patients with sick sinus syndrome&#xD;
&#xD;
               -  pregnant women&#xD;
&#xD;
               -  mental disorders&#xD;
&#xD;
               -  patients that have allergy to contrast agent&#xD;
&#xD;
               -  patients that do not go with follow-up&#xD;
&#xD;
               -  others such as researcher considers it is not appropriate to be included into the&#xD;
                  study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuehui Yin, MD</last_name>
    <phone>0086-13508335502</phone>
    <email>yinyh63@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>2ndChongqingMU</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuehui Yin, MD</last_name>
      <phone>0086-23-63693766</phone>
      <email>yinyh63@163.com</email>
    </contact>
    <investigator>
      <last_name>Yuehui Yin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>March 18, 2019</last_update_submitted>
  <last_update_submitted_qc>March 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Yuehui Yin</investigator_full_name>
    <investigator_title>Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</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/NCT01686542
org study id: SWAN-cpAF
nct id: NCT01686542
lead sponsor: 
has dmc: Yes
The study is designed as a randomized control trial. The purpose of this study is to observe
      the efficacy and safety of atrial fibrillation ablation, comparing circumferential pulmonary
      vein isolation (CPVI) plus renal sympathetic modification (RSM) with CPVI alone.
Basic studies suggested that sympathetic nerves over-activity played an important role in the
      pathophysiological changes of arrhythmia occurrence. Present studies of renal ablation show a
      new method to decrease sympathetic nerves activity. Circumferential pulmonary vein isolation
      (CPVI) is an accepted ablation method for atrial fibrillation. The investigators plan to
      evaluate the efficiency and safety of CPVI plus renal sympathetic modification for atrial
      fibrillation ablation comparing with CPVI alone. The trial is going to recruit 100 patients
      randomized into two groups (CPVI+RSM group VS CPVI group = 50:50) with a follow-up duration
      of 4 years. The investigators aim to observe the relapse of atrial tachyarrhythmia lasting
      more than 30 seconds, the incidence of composite cardiovascular events after renal
      sympathetic modification, and safety and efficacy of the intervention, comparing with CPVI
      alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The relapse rate of atrial tachyarrhythmia
time frame: Four years
description: Atrial tachyarrhythmia lasting more than 30 seconds consider relapsed
arm group label: CPVI+RSM group
arm group type: Experimental
description: Circumferential pulmonary vein isolation (CPVI) plus renal sympathetic modification for atrial fibrillation ablation.
arm group label: CPVI group
arm group type: Active Comparator
description: Circumferential pulmonary vein isolation is done alone for atrial fibrillation.
intervention type: Procedure
intervention name: CPVI plus renal sympathetic modification
description: CPVI plus renal denervation to reduce atrial arrhythmia recurrence.
arm group label: CPVI+RSM group
other name: Circumferential pulmonary vein isolation (CPVI)
other name: renal denervation
other name: renal ablation
intervention type: Procedure
intervention name: CPVI
description: CPVI alone to reduce atrial arrhythmia recurrence.
arm group label: CPVI group
other name: circumferential pulmonary vein ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yuehui Yin, MD
phone: 0086-13508335502
email: yinyh63@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital of Chongqing Medical University
investigator full name: Yuehui Yin
investigator title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
mesh term: Atrial Fibrillation