<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/NCT04489004</url>
  </required_header>
  <id_info>
    <org_study_id>Credit-AF</org_study_id>
    <nct_id>NCT04489004</nct_id>
  </id_info>
  <brief_title>The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.</brief_title>
  <official_title>Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Chest Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Chest Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open label, multi-center, randomized parallel control clinical trial, to&#xD;
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial&#xD;
      fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in&#xD;
      patients with persistent atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, multi-center, randomized parallel control clinical trial. Patients&#xD;
      with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver&#xD;
      ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation).&#xD;
      Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to&#xD;
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial&#xD;
      fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in&#xD;
      patients with persistent atrial fibrillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>Postoperative atrial fibrillation (AF) recurrence rate</measure>
    <time_frame>up to 24 months after enrollment</time_frame>
    <description>AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural AF termination rate</measure>
    <time_frame>Before the end of procedure.</time_frame>
    <description>AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate</measure>
    <time_frame>up to 24 months after enrollment</time_frame>
    <description>Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>up to 2 weeks after enrollment</time_frame>
    <description>Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1298</enrollment>
  <condition>Atrial Fibrillation, Persistent</condition>
  <arm_group>
    <arm_group_label>Driver ablation+CPVI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Driver ablation plus CPVI (circumferential pulmonary vein isolation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stepwise ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Stepwise ablation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Driver ablation+CPVI</intervention_name>
    <description>Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).</description>
    <arm_group_label>Driver ablation+CPVI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stepwise ablation</intervention_name>
    <description>Patients receive stepwise ablation.</description>
    <arm_group_label>Stepwise ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 to 80 years old;&#xD;
&#xD;
          2. Persistent AF;&#xD;
&#xD;
          3. nonresponse or intolerance to ≥1 antiarrhythmic drug. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With uncontrolled congestive heart failure;&#xD;
&#xD;
          2. Having significant valvular disease and/or prosthetic heart valve(s);&#xD;
&#xD;
          3. With myocardial infarction or stroke within 6 months of screening;&#xD;
&#xD;
          4. With Significant congenital heart disease;&#xD;
&#xD;
          5. Ejection fraction was &lt;40% measured by echocardiography;&#xD;
&#xD;
          6. Allergic to contrast media;&#xD;
&#xD;
          7. Contraindication to anticoagulation medications;&#xD;
&#xD;
          8. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive&#xD;
             disease (COPD);&#xD;
&#xD;
          9. Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;&#xD;
&#xD;
         10. Having any contraindication to right or left sided heart catheterization;&#xD;
&#xD;
         11. Previous atrial fibrillation ablation;&#xD;
&#xD;
         12. Presence of an implanted cardioverter-defibrillator;&#xD;
&#xD;
         13. Any cardiac surgery within the past 2 months;&#xD;
&#xD;
         14. Poor general health;&#xD;
&#xD;
         15. Life expectancy less than 6 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanghai Chest Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Chest Hospital</investigator_affiliation>
    <investigator_full_name>Xu Liu</investigator_full_name>
    <investigator_title>Professor, deputy director of cardiology department of Shanghai Chest Hospital</investigator_title>
  </responsible_party>
  <keyword>Persistent Atrial Fibrillation</keyword>
  <keyword>Driver ablation</keyword>
  <keyword>Stepwise ablation</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/NCT04489004
org study id: Credit-AF
nct id: NCT04489004
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This is an open label, multi-center, randomized parallel control clinical trial, to
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial
      fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in
      patients with persistent atrial fibrillation.
This is an open label, multi-center, randomized parallel control clinical trial. Patients
      with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver
      ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation).
      Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to
      demonstrate the role of driver mechanism in maintenance substrate of persistent atrial
      fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in
      patients with persistent atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postoperative atrial fibrillation (AF) recurrence rate
time frame: up to 24 months after enrollment
description: AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
measure: Procedural AF termination rate
time frame: Before the end of procedure.
description: AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).
measure: Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate
time frame: up to 24 months after enrollment
description: Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.
measure: Incidence of complications
time frame: up to 2 weeks after enrollment
description: Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.
arm group label: Driver ablation+CPVI
arm group type: Experimental
description: Driver ablation plus CPVI (circumferential pulmonary vein isolation)
arm group label: Stepwise ablation
arm group type: Active Comparator
description: Stepwise ablation
intervention type: Procedure
intervention name: Driver ablation+CPVI
description: Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
arm group label: Driver ablation+CPVI
intervention type: Procedure
intervention name: Stepwise ablation
description: Patients receive stepwise ablation.
arm group label: Stepwise ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Chest Hospital
investigator full name: Xu Liu
investigator title: Professor, deputy director of cardiology department of Shanghai Chest Hospital
mesh term: Atrial Fibrillation