<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/NCT02991170</url>
  </required_header>
  <id_info>
    <org_study_id>XMLX201504</org_study_id>
    <nct_id>NCT02991170</nct_id>
  </id_info>
  <brief_title>Effect of Radiofrequency Ablation in Patients With Ventricular Arrhythmia Undergoing CABG</brief_title>
  <acronym>RACAVA</acronym>
  <official_title>Impact of Radiofrequency Ablation Therapy in Coronary Artery Bypass Grafts Surgery on Outcomes in Patients With Myocardial Infarction Related Ventricular Arrhythmia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuanwu Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Anzhen Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with myocardial infarction related potential malignant ventricular arrhythmia have&#xD;
      high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy&#xD;
      of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG)&#xD;
      Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular&#xD;
      arrhythmia at the same time. The observation indexes include the morbidity of potential&#xD;
      malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term&#xD;
      after CABG surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morbidity of potential malignant ventricular arrhythmia</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morbidity of major adverse cardiovascular events</measure>
    <time_frame>1 year after surgery</time_frame>
    <description>The morbidity of the major adverse cardiovascular events in 1 year after surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cardiac function</measure>
    <time_frame>Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery</time_frame>
    <description>Change from Baseline Cardiac Function evaluated by echocardiography at 3 month, 6 month, 1 year, 2 year after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac electrophysiology index</measure>
    <time_frame>Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery</time_frame>
    <description>Change from Baseline Cardiac Electrophysiology Index evaluated by Holter and cardiac magnetic resonance imaging or CARTO at 1 year and 2 year after surgery</description>
  </other_outcome>
  <other_outcome>
    <measure>Seattle Angina Questionnaire</measure>
    <time_frame>Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery</time_frame>
    <description>Change from Baseline the Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>MI Related Malignant Ventricular Arrhythmia</condition>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>interventional group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>unipolar or bipolar radiofrequency ablation+CABG</intervention_name>
    <description>Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time</description>
    <arm_group_label>interventional group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CABG</intervention_name>
    <description>Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients have been receiving coronary artery bypass grafts from 2015.1-2017.12&#xD;
&#xD;
          -  The patients had old myocardial infarction related potential malignant ventricular&#xD;
             arrhythmia&#xD;
&#xD;
          -  Anti-arrhythmic drug treatment is invalid&#xD;
&#xD;
          -  All enrolled patients must being signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe heart failure( ejection fraction under 35%)&#xD;
&#xD;
          -  Patients with acute myocardial infarction&#xD;
&#xD;
          -  Patients with ICD implanted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Xuanwu Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Xu, doctor</last_name>
      <phone>+8613910868737</phone>
      <email>lancetzkf@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Tian, doctor</last_name>
      <phone>+8613601117313</phone>
      <email>doctorty2000@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yang Yu, doctor</last_name>
      <phone>+8613911524101</phone>
      <email>13911524101@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Mingxin Gao, master</last_name>
      <phone>+8618611979396</phone>
      <email>star880312@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>December 9, 2016</last_update_submitted>
  <last_update_submitted_qc>December 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Yang Yu</investigator_full_name>
    <investigator_title>Deputy Director of Cardiac Surgery, Principal Investigator,Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>myocardial infarction</keyword>
  <keyword>ventricular arrhythmia</keyword>
  <keyword>radiofrequency ablation</keyword>
  <keyword>Coronary Artery Bypass Grafts</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02991170
org study id: XMLX201504
nct id: NCT02991170
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Patients with myocardial infarction related potential malignant ventricular arrhythmia have
      high risk of sudden death. The aim of this clinical trial is evaluating therapeutic efficacy
      of unipolar or bipolar radiofrequency ablation in Coronary Artery Bypass Grafts (CABG)
      Surgery, which can reduce myocardial ischemia and block reentry circuits of ventricular
      arrhythmia at the same time. The observation indexes include the morbidity of potential
      malignant ventricular arrhythmia and major adverse cardiovascular events in mid-long-term
      after CABG surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Morbidity of potential malignant ventricular arrhythmia
time frame: 1 year after surgery
description: The morbidity of potential malignant ventricular arrhythmia in 1 year after surgery
measure: Morbidity of major adverse cardiovascular events
time frame: 1 year after surgery
description: The morbidity of the major adverse cardiovascular events in 1 year after surgery
measure: Cardiac function
time frame: Change from Baseline Cardiac Function at 3 month, 6 month, 1 year, 2 year after surgery
description: Change from Baseline Cardiac Function evaluated by echocardiography at 3 month, 6 month, 1 year, 2 year after surgery
measure: Cardiac electrophysiology index
time frame: Change from Baseline Cardiac Electrophysiology Index at 1 year and 2 year after surgery
description: Change from Baseline Cardiac Electrophysiology Index evaluated by Holter and cardiac magnetic resonance imaging or CARTO at 1 year and 2 year after surgery
measure: Seattle Angina Questionnaire
time frame: Change from Baseline Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
description: Change from Baseline the Seattle Angina Questionnaire at 3 month, 6 month, 1 year, 2 year after surgery
arm group label: control group
arm group type: Active Comparator
description: Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
arm group label: interventional group
arm group type: Experimental
description: Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
intervention type: Procedure
intervention name: unipolar or bipolar radiofrequency ablation+CABG
description: Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
arm group label: interventional group
intervention type: Procedure
intervention name: CABG
description: Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
arm group label: control group
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Yang Yu
investigator title: Deputy Director of Cardiac Surgery, Principal Investigator,Clinical Professor
mesh term: Arrhythmias, Cardiac
sharing ipd: Undecided