<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/NCT04497376</url>
  </required_header>
  <id_info>
    <org_study_id>2017YFC0908803</org_study_id>
    <nct_id>NCT04497376</nct_id>
  </id_info>
  <brief_title>Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation</brief_title>
  <acronym>PROMPT-AF</acronym>
  <official_title>Prospective Randomized Comparison Between Upgraded '2C3L' vs. PVI Approach for Catheter Ablation of Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Anzhen Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart Health Research Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The George Institute for Global Health, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The George Institute for Global Health, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fukuoka University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Anzhen Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Catheter ablation has emerged as an important treatment option for patients with symptomatic&#xD;
      atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the&#xD;
      cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial&#xD;
      fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF&#xD;
      (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains&#xD;
      controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving&#xD;
      a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival&#xD;
      between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of&#xD;
      PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1&#xD;
      fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM,&#xD;
      bilateral circumferential PVI, and three linear ablation lesion sets across the mitral&#xD;
      isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months.&#xD;
      The primary endpoint is the rate of documented atrial tachycardia arrhythmias of &gt;30 seconds,&#xD;
      without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding&#xD;
      a blanking period of 3 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 27, 2021</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The recurrence rate of atrial tachycardia arrhythmias</measure>
    <time_frame>1 year</time_frame>
    <description>freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Freedom from AF/AT with or without AADs</measure>
    <time_frame>1 year</time_frame>
    <description>Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AF/AT off AADs</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AF off AADs</measure>
    <time_frame>1 year</time_frame>
    <description>Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AF burden</measure>
    <time_frame>1 year</time_frame>
    <description>AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Freedom from AF/AT after multiple procedures</measure>
    <time_frame>1 year</time_frame>
    <description>freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of procedural complications</measure>
    <time_frame>Within 1 month after the procedure</time_frame>
    <description>cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AFEQT score change between baseline and 12 month</measure>
    <time_frame>1 year</time_frame>
    <description>Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ5D score change between baseline and 12 month</measure>
    <time_frame>1 year</time_frame>
    <description>Quality of life assessed by EuroQol 5-dimension (EQ5D) scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">498</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <condition>Catheter Ablation</condition>
  <arm_group>
    <arm_group_label>Upgraded '2C3L'</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pulmonary vein antral isolation (PVI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>upgraded '2C3L'</intervention_name>
    <description>Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.</description>
    <arm_group_label>Upgraded '2C3L'</arm_group_label>
    <other_name>EI-VOM+2C3L</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulmonary vein antral isolation</intervention_name>
    <description>After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.</description>
    <arm_group_label>Pulmonary vein antral isolation (PVI)</arm_group_label>
    <other_name>PVI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
        Patients must meet all the following criteria to be included in the study:&#xD;
&#xD;
          1. age between 18 and 80,&#xD;
&#xD;
          2. patients undergoing a first-time ablation procedure for non-valvular AF,&#xD;
&#xD;
          3. patients with defined as a sustained episode more than 3 months&#xD;
&#xD;
          4. PeAF documented by ECG, Holter, loop recorder, telemetry, trans-telephonic monitor or&#xD;
             implanted device within 90 days6 months of the ablation procedure,&#xD;
&#xD;
          5. patients experienced symptoms caused by AF and these symptoms include but are not&#xD;
             limited to palpitations, presyncope, syncope, fatigue, and shortness of breath,&#xD;
&#xD;
          6. AF refractory to at least one AAD,&#xD;
&#xD;
          7. willingness, ability and commitment to provide informed consent and participate in&#xD;
             follow-up evaluations.&#xD;
&#xD;
        Exclusion criteria Patients are to be excluded if any of the following criteria is met：&#xD;
&#xD;
          1. patients with paroxysmal AF,&#xD;
&#xD;
          2. patients with AF secondary to an obvious reversible cause,&#xD;
&#xD;
          3. patients with left atrial diameter ≥ 60 mm in the parasternal long axis view,&#xD;
&#xD;
          4. left ventricular ejection fraction (LVEF) &lt; 30%,&#xD;
&#xD;
          5. patients with triple (aspirin, clopidogrel and OAC) or dual (clopidogrel and OAC)&#xD;
             antithrombotic therapy which predispose patients to higher risk of periprocedural&#xD;
             bleeding. (e.g., Coronary percutaneous transluminal coronary angioplasty&#xD;
             (PTCA)/stenting within the previous 90 days),&#xD;
&#xD;
          6. patients with contraindication to anticoagulation,&#xD;
&#xD;
          7. patients with contraindication to right or left sided heart catheterization,&#xD;
&#xD;
          8. pregnancy,&#xD;
&#xD;
          9. life expectancy less than 1 year (advanced malignant tumor, end stage renal disease,&#xD;
             etc.),&#xD;
&#xD;
         10. patients cannot be removed from antiarrhythmic drugs for reasons other than AF.&#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_official>
    <last_name>Caihua Sang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Changsheng Ma, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anzhen Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jianzeng Dong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chenyang Jiang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Run Run Shaw Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Du Xin, Doctor</last_name>
    <phone>86-10-64420102</phone>
    <email>duxinheart@sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xiaoxia Liu, Doctor</last_name>
    <email>dr_lxx@126.com</email>
  </overall_contact_backup>
  <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>Caihua Sang, MD</last_name>
      <phone>+861084005365</phone>
      <email>sch9613070@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen Memorial Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510235</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shuanglun Xie</last_name>
      <email>xieshuanglun@sina.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Taizhou Hospital of Zhejiang Province</name>
      <address>
        <city>Taizhou</city>
        <state>Hangzhou</state>
        <zip>318050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weili Ge</last_name>
      <email>gewl@enzemed.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Harbin Medical University</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhaojun Wang</last_name>
      <email>hyd2013@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fuwai Central China Cardiovascular Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>451464</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ke Chen</last_name>
      <email>chenke1985@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wuhan Asia Heart Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jinlin Zhang</last_name>
      <email>zjl1974@yeah.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jiangsu Provincial Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiangang Zou</last_name>
      <email>jgzou@njmu.edu.cn</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shengli Oilfield Central Hospital</name>
      <address>
        <city>Dongying</city>
        <state>Shandong</state>
        <zip>257034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangfei Liu</last_name>
      <email>zhaoyang20023903@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Shandong First Medical University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hesheng Hu</last_name>
      <email>hyperhhs@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shangming Song</last_name>
      <email>13808936009@163.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinhua Wang</last_name>
      <email>ttwwxh@126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chenyang Jiang</last_name>
      <email>chenyangjiangmail@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Anzhen Hospital</investigator_affiliation>
    <investigator_full_name>Chang sheng Ma</investigator_full_name>
    <investigator_title>Director of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Pulmonary vein antral isolation</keyword>
  <keyword>Upgraded '2C3L'</keyword>
  <keyword>Arrhythmia-free survival</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/NCT04497376
org study id: 2017YFC0908803
nct id: NCT04497376
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Catheter ablation has emerged as an important treatment option for patients with symptomatic
      atrial fibrillation (AF). Pulmonary vein antral isolation (PVI) is now considered the
      cornerstone technique of AF ablation and has shown promise in treating paroxysmal atrial
      fibrillation (PAF). However, there is no unique strategy for ablation of persistent AF
      (PeAF), whether PVI alone is sufficient to prevent patients from recurrence remains
      controversial. The PROMPT-AF study is a prospective, multicenter, randomized trial involving
      a blinded assessment of outcomes, which is designed to compare arrhythmia-free survival
      between PVI and an ablation strategy termed upgraded '2C3L' for ablation of PeAF.
The PROMPT-AF study will include 498 patients undergoing their first catheter ablation of
      PeAF. All patients will be randomized to either the upgraded '2C3L' arm or PVI arm in a 1:1
      fashion. The upgraded '2C3L' technique is a fixed ablation approach consisting of EI-VOM,
      bilateral circumferential PVI, and three linear ablation lesion sets across the mitral
      isthmus, left atrial roof, and cavotricuspid isthmus. The follow-up duration is 12 months.
      The primary endpoint is the rate of documented atrial tachycardia arrhythmias of >30 seconds,
      without any antiarrhythmic drugs, in 12 months after the index ablation procedure (excluding
      a blanking period of 3 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The recurrence rate of atrial tachycardia arrhythmias
time frame: 1 year
description: freedom from any documented atrial arrhythmia after a 3-months post-ablation blanking period, including AF, AT, and AFL, for more than 30 seconds in the absence of antiarrhythmic drug (AAD) therapy.
measure: Freedom from AF/AT with or without AADs
time frame: 1 year
description: Time to the first occurrence of AF, AT in the presence of AAD therapy after one ablation procedure.
measure: Freedom from AF/AT off AADs
time frame: 1 year
description: Recurrent AT/AFL over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
measure: Freedom from AF off AADs
time frame: 1 year
description: Recurrent AF over 30 seconds after a 3-month post-ablation blanking period in the absence of AAD
measure: AF burden
time frame: 1 year
description: AF burden (% time) on continuous monitoring during 12 months after the 3-months blanking period,
measure: Freedom from AF/AT after multiple procedures
time frame: 1 year
description: freedom from any documented atrial arrhythmia (AF, AT, and AFL) of more than 30 seconds, after repeated ablation1 or 2 ablation procedures, including AF, AT, and AFL, for more than 30 seconds on/off AADs.
measure: Incidence of procedural complications
time frame: Within 1 month after the procedure
description: cardiac tamponade or perforation, phrenic nerve injury, acute coronary occlusion, leading to death, intervention required, or prolonged hospitalization, strokes /thromboembolism related to AF ablation, pulmonary vein stenosis, left atrial oesophageal fistula, and vascular complications requiring intervention (e.g., pseudoaneurysm, arteriovenous fistula).
measure: AFEQT score change between baseline and 12 month
time frame: 1 year
description: Quality of life assessed by AF effect on quality-of-life (AFEQT) questionaire
measure: EQ5D score change between baseline and 12 month
time frame: 1 year
description: Quality of life assessed by EuroQol 5-dimension (EQ5D) scale
arm group label: Upgraded '2C3L'
arm group type: Experimental
description: Patients randomized to the upgraded '2C3L' arm will first undergo ethanol infusion in the vein of Marshall (EI-VOM) followed by the '2C3L' ablation step which includes bilateral circumferential PV antral ablation and linear ablations across the left atrial roof, mitral isthmus (MI), and cavotricuspid isthmus (CTI).
arm group label: Pulmonary vein antral isolation (PVI)
arm group type: Active Comparator
description: Patients randomized to the PVI arm will undergo right PV antrum ablation, followed by the left PVA ablation. Radiofrequency should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished.
intervention type: Procedure
intervention name: upgraded '2C3L'
description: Patients randomized to the upgraded '2C3L' arm will first undergo EI-VOM, followed by the '2C3L' ablation step. The details include: (1). EI-VOM procedure: An 8.5-French-long sheath or a steerable long sheath is sent to the coronary sinus (CS) via the femoral vein. A JR4.0 catheter is inserted into the CS to identify the ostium of the VOM. Subsequently, a BMW wire supported by an OTW balloon catheter is advanced into the VOM. The balloon is inflated with 6 to 8 atm in the VOM. A selective venogram of the VOM is obtained by slowly injecting 1 mL of contrast medium. Then, ethanol is slowly injected into the VOM and selective venography of the VOM is repeated. (2) . After EI-VOM, radiofrequency ablation was performed to achieve bilateral pulmonary vein isolation and bidirectional block of mitral isthmus line, roof line, and cavotricuspid isthmus line. (3). Any organized AT observed during the procedure will be targeted as well.
arm group label: Upgraded '2C3L'
other name: EI-VOM+2C3L
intervention type: Procedure
intervention name: pulmonary vein antral isolation
description: After reconstructing the left atrial geometry, PVI will be performed (the right PV antrum (PVA) will be ablated first, followed by the left PVA. ) in a wide area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. The endpoint of the circumferential PVA ablation procedure is to achieve electrical bilateral PV isolation, that is, the PV potentials associated with atrial electrical activity cannot be recorded during sinus rhythm or CS pacing (entrance block). A waiting period of at least 20 min (after the last PV is isolated) will be used during which spontaneous PV reconnection will be related. , and tDemonstration of exit block (he by pacing in the PV cannot be and proving the absence of transmitted conduction to capture the atrium) may be performed but is not mandatory. Any organized AT observed during the procedure will be targeted as well.
arm group label: Pulmonary vein antral isolation (PVI)
other name: PVI
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Caihua Sang, MD
role: Principal Investigator
affiliation: Beijing Anzhen Hospital
last name: Changsheng Ma, MD
role: Principal Investigator
affiliation: Beijing Anzhen Hospital
last name: Jianzeng Dong, MD
role: Principal Investigator
affiliation: Beijing Anzhen Hospital; The First Affiliated Hospital of Zhengzhou University
last name: Chenyang Jiang, MD
role: Principal Investigator
affiliation: Sir Run Run Shaw Hospital
last name: Du Xin, Doctor
phone: 86-10-64420102
email: duxinheart@sina.com
last name: Xiaoxia Liu, Doctor
email: dr_lxx@126.com
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country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Anzhen Hospital
investigator full name: Chang sheng Ma
investigator title: Director of Cardiology
mesh term: Atrial Fibrillation