xml: <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/NCT06014996</url>
    </required_header>
    <id_info>
      <org_study_id>101000001M-CIP-001</org_study_id>
      <nct_id>NCT06014996</nct_id>
    </id_info>
    <brief_title>Comparison of PFA vs. RFA in Patients With Symptomatic Paroxysmal Atrial Fibrillation.</brief_title>
    <official_title>A Prospective, Multicenter, Randomized, and Controlled Study of Pulsed Field Ablation System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insight Medtech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Insight Lifetech Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangdong Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Anzhen Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanghai Zhongshan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated People's Hospital of Ningbo University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Dalian Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nanfang Hospital, Southern Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiamen Cardiovascular Hospital, Xiamen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yan'an Affiliated Hospital of Kunming Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Weifang People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Insight Lifetech Co., Ltd.</source>
    <oversight_info>
      <has_dmc>No</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>
        This study is a mulitcentre, randomized, parallel-group evaluation of pulse field&#xD;
        ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic&#xD;
        paroxysmal AF.&#xD;
  &#xD;
        Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight&#xD;
        Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the&#xD;
        ablation procedure, the (1:1) randomly selected ablation modality is used in the left&#xD;
        atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators&#xD;
        demonstrates the success of PVI by the abolition of conduction of atrial impulses into the&#xD;
        PVs.&#xD;
  &#xD;
        Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not&#xD;
        allowed, and adenosine testing not performed, in either group. Concomitant ablation of&#xD;
        previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the&#xD;
        ablation procedure in both groups.&#xD;
  &#xD;
        The acute procedural end point is defined as the absence or dissociation of all PV&#xD;
        potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20&#xD;
        min waiting period (subsequent to the last ablation).&#xD;
  &#xD;
        Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking&#xD;
        period is allowed if the re-ablation is performing with the same type of catheter used at the&#xD;
        ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD)&#xD;
        administration is allowed, but amiodarone iscontinuation is required at the time of the&#xD;
        ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during&#xD;
        this trail.&#xD;
  &#xD;
        The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of&#xD;
        no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3&#xD;
        months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG&#xD;
        or dynamic ECG).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>
      <intervention_model_description>symptomatic paroxysmal AF</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the 12-month treatment success rate</measure>
      <time_frame>from the blanking period to the end of 12-month follow-up</time_frame>
      <description>12-month treatment success rate of abaltion, absence of atrial arrhythmia recurrence(AF/AFL/AT) on any type of recording (ECG or Holter),absence of use of class I or III AAD.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immediate success rate</measure>
      <time_frame>20 minutes after the ablation</time_frame>
      <description>Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total procedure time</measure>
      <time_frame>During the procedure</time_frame>
      <description>Procedure duration in minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total left atrium indwelling time</measure>
      <time_frame>During the procedure</time_frame>
      <description>Procedure duration in minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total abaltion time</measure>
      <time_frame>During the procedure</time_frame>
      <description>Procedure duration in minute</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total X-ray exposure time</measure>
      <time_frame>During the procedure</time_frame>
      <description>Total time of X-ray exposure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total X-ray exposure dose</measure>
      <time_frame>During the procedure</time_frame>
      <description>Total dose of X-ray exposure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants under general anesthesia</measure>
      <time_frame>During the procedure</time_frame>
      <description>Comparison of number of patients under general anesthesia between two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the ablation system（questionnaire）</measure>
      <time_frame>immediately post ablation</time_frame>
      <description>To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :&#xD;
  the stability of the ablation system ;&#xD;
  the usability of the ablation system .&#xD;
  For each system in 1., 2., and 3., only one of the following five ratings is given:&#xD;
  very stable;&#xD;
  stable, inspection was unaffected;&#xD;
  slightly unstable, inspection was unaffected;&#xD;
  N/A.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the ablation catheter（questionnaire）</measure>
      <time_frame>immediately post ablation</time_frame>
      <description>To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :&#xD;
  whether the ablation catheter can reach the expected position smoothly for ablation；&#xD;
  whether the ablation catheter can be visible clearly under X-ray；&#xD;
  whether the energy of the ablation catheter cannot be released after system operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the adjustable introducer sheath set（questionnaire）</measure>
      <time_frame>immediately post ablation</time_frame>
      <description>To evaluate the adjustable introducer sheath set of the investigation device， including below measures :&#xD;
  whether the introducer sheath can reach the expected position smoothly for ablation；&#xD;
  whether the introducer sheath can be visible clearly under X-ray；&#xD;
  whether the curved shape of the introducer sheath can be adjustable。</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of composite safety endpoint</measure>
      <time_frame>12 months after the ablation</time_frame>
      <description>Composite safety endpoint composed of: death、stroke and transient ischemic attack</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of surgical complications</measure>
      <time_frame>12 months after the ablation</time_frame>
      <description>surgical complications composed of: Vascular puncture/bleeding complications, cardiac tamponade and/or perforation, left atrium-esophageal fistula, phrenic nerve injury, pulmonary vein stenosis, etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe adverse events</measure>
      <time_frame>12 months after the ablation</time_frame>
      <description>Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of device-related adverse events</measure>
      <time_frame>12 months after the ablation</time_frame>
      <description>Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">292</enrollment>
    <condition>Arrhythmias, Cardiac</condition>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Pulsed Field Ablation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PVI using the PFA system (Insight Medtech).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radiofrequency Ablation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PVI using the RFA system ((Biosense Webster).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pulsed Field Ablation (PFA) Therapy</intervention_name>
      <description>Patients randomized to thePulsed Field Ablation group will undergo PVI using the PFA system (Insight Medtech).</description>
      <arm_group_label>Pulsed Field Ablation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Radiofrequency Ablation（RAF）Therapy</intervention_name>
      <description>Patients randomized to Radiofrequency Ablation group will undergo PVI using the RFA system (Biosense Webster).</description>
      <arm_group_label>Radiofrequency Ablation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18 years old ≤ age ≤ 75 years old, gender is not limited;&#xD;
  &#xD;
            2. Patients with symptomatic paroxysmal atrial fibrillation confirmed by&#xD;
               electrocardiogram or clinically diagnosed；&#xD;
  &#xD;
            3. Catheter ablation of atrial fibrillation is planned;&#xD;
  &#xD;
            4. Agree to participate in this clinical trial, and voluntarily sign an informed consent&#xD;
               form, and are willing to complete relevant inspections and follow-up visits in&#xD;
               accordance with the requirements of the protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous surgery or catheter ablation for atrial fibrillation;&#xD;
  &#xD;
            2. The clinical diagnosis is persistent or long-term persistent atrial fibrillation;&#xD;
  &#xD;
            3. Patients with left ventricular ejection fraction (LVEF) &lt;40%, or patients with NYHA&#xD;
               cardiac function class III and IV;&#xD;
  &#xD;
            4. Left atrial diameter (echocardiography) ≥ 50mm;&#xD;
  &#xD;
            5. Imaging examination results suggest left atrium or left atrial appendage thrombus;&#xD;
  &#xD;
            6. There is a history of anticoagulation contraindications, abnormal blood coagulation or&#xD;
               bleeding;&#xD;
  &#xD;
            7. Patients with acute/active systemic infection;&#xD;
  &#xD;
            8. Severe lung disease, pulmonary hypertension, or any lung disease involving severe&#xD;
               dyspnea such as blood gas abnormalities;&#xD;
  &#xD;
            9. Clinically diagnosed as hypertrophic cardiomyopathy, chronic obstructive pulmonary&#xD;
               disease, known or suspected atrial myxoma;&#xD;
  &#xD;
           10. Previous heart valve repair or replacement or artificial valve implantation; previous&#xD;
               history of atrial septal defect closure, patent foramen ovale closure cardiac&#xD;
               intervention or surgery;&#xD;
  &#xD;
           11. Patients with cardioverter-defibrillators or other active implanted devices implanted&#xD;
               in their bodies;&#xD;
  &#xD;
           12. Myocardial infarction, unstable angina pectoris or any cardiac intervention/open&#xD;
               surgery (except coronary angiography examination) occurred within 3 months;&#xD;
               hospitalization due to heart failure, stroke (except asymptomatic stroke) within 3&#xD;
               months ) or transient ischemic attack;&#xD;
  &#xD;
           13. Received any carotid artery stent placement or endarterectomy within 6 months;&#xD;
  &#xD;
           14. Patients who have obvious contraindications to interventional surgery and are judged&#xD;
               by the investigator to be unable to undergo ablation surgery;&#xD;
  &#xD;
           15. Participated in clinical trials of other drugs or devices during the same period;&#xD;
  &#xD;
           16. Life expectancy is less than 12 months (such as advanced malignant tumor);&#xD;
  &#xD;
           17. Women who are pregnant or breastfeeding or those who have family planning during the&#xD;
               trial;&#xD;
  &#xD;
           18. Other circumstances considered by the investigators to be inappropriate to participate&#xD;
               in this clinical trial.&#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>Yumei Xue, PhD</last_name>
      <phone>+86-13570082363</phone>
      <email>xymgdci@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Weidong Lin, PhD</last_name>
      <phone>+86-15914322775</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Beijing Anzhen Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Songnan Li, PhD</last_name>
        <phone>+86-13671346119</phone>
        <email>lisongnan@ccmu.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Lihong Huang, PhD</last_name>
        <phone>+86-15652491982</phone>
        <email>husthlh@163.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Xiamen Cardiovascular Hospital, Xiamen University</name>
        <address>
          <city>Xiamen</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dong Chang, PhD</last_name>
        <phone>+86-13779963201</phone>
        <email>cdheart@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yumei Xue, PhD</last_name>
        <phone>+8613570082363</phone>
        <email>xymgdci@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Hongtao Liao, PhD</last_name>
        <email>liaohongtong@163.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Nanfang Hospital, Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yuegang Wang, MD</last_name>
        <phone>+86-13725265686</phone>
        <email>wyg06@fimmu.com</email>
      </contact>
      <contact_backup>
        <last_name>Senlin Huang, MD</last_name>
        <phone>+86-13268283120</phone>
        <email>1481561982@qq.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Dalian Medical University</name>
        <address>
          <city>Dalian</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xiaomeng Yin, MD</last_name>
        <phone>+86-13840885309</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Weifang People's Hospital</name>
        <address>
          <city>Weifang</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yanbo Chen</last_name>
        <phone>+86-15166460788</phone>
      </contact>
      <contact_backup>
        <last_name>Xuefu Hang</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Shanghai Zhongshan Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wenqing Zhu, PhD</last_name>
        <phone>+86-13701630800</phone>
      </contact>
    </location>
    <location>
      <facility>
        <name>Yan'an Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Shaolong Li, Ph.D</last_name>
        <phone>+86-13700651472</phone>
        <email>13700651472@126.com</email>
      </contact>
      <contact_backup>
        <last_name>Qiwei Liao, MD</last_name>
        <phone>+86-13678751296</phone>
        <email>13678751296@126.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Sir Run Run Shaw Hospital</name>
        <address>
          <city>Hanzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Affiliated People's Hospital of Ningbo University</name>
        <address>
          <city>Ningbo</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Huimin Chu, MD</last_name>
        <phone>+86-13566336742</phone>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>pulsed field ablation</keyword>
    <keyword>Radiofrequency Ablation</keyword>
    <keyword>Pulmonary Vein Isolation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
      <mesh_term>Arrhythmias, Cardiac</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014996
  org study id: 101000001M-CIP-001
  nct id: NCT06014996
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a mulitcentre, randomized, parallel-group evaluation of pulse field
        ablation(PFA) and radiofrequency ablation(RFA) in patients being treated for symptomatic
        paroxysmal AF.
  
        Pulmonary-vein isolation (PVI) is the primary intention of catheter ablation in both groups.
  Patients are randomized to either pulse field ablation(PFA) using the PFA catheters(Insight
        Medtech) or radiofrequency ablation(RFA) using the RFA catheters（Biosense Webster).During the
        ablation procedure, the (1:1) randomly selected ablation modality is used in the left
        atriuablation procedurem to electrically isolate the pulmonary veins (PVs).All investigators
        demonstrates the success of PVI by the abolition of conduction of atrial impulses into the
        PVs.
  
        Additional LA linear lesions or complex fractionated atrial electrogram ablation(s) are not
        allowed, and adenosine testing not performed, in either group. Concomitant ablation of
        previously documented avotricuspid isthmus-dependent atrial flutter (AFL) is allowed at the
        ablation procedure in both groups.
  
        The acute procedural end point is defined as the absence or dissociation of all PV
        potentials, as confirmed by bi-directional block using a circular mapping catheter after a 20
        min waiting period (subsequent to the last ablation).
  
        Randomized groups are held throughout the trial, and re-ablation during the 3-month blanking
        period is allowed if the re-ablation is performing with the same type of catheter used at the
        ablation procedure. During the 3-month blanking period, antiarrhythmic drug (AAD)
        administration is allowed, but amiodarone iscontinuation is required at the time of the
        ablation procedure. Beta-adrenergic blockers is permitted and can be used at any time during
        this trail.
  
        The primary efficacy endpoint is the 12-month treatment success rate，defining as the use of
        no class I or III AAD and no AF/AFL/AT episodes between the time of ablation blank (within 3
        months after the ablation procedure) and 12 months of follow-up. (Confirmed by a definite ECG
        or dynamic ECG).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: symptomatic paroxysmal AF
  primary purpose: Treatment
  masking: None (Open Label)
  measure: the 12-month treatment success rate
  time frame: from the blanking period to the end of 12-month follow-up
  description: 12-month treatment success rate of abaltion, absence of atrial arrhythmia recurrence(AF/AFL/AT) on any type of recording (ECG or Holter),absence of use of class I or III AAD.
  measure: Immediate success rate
  time frame: 20 minutes after the ablation
  description: Immediate success rate refers to maintaining electrical isolation of the pulmonary vein 20 minutes after completion of all pulmonary vein ablation.
  measure: Total procedure time
  time frame: During the procedure
  description: Procedure duration in minute
  measure: Total left atrium indwelling time
  time frame: During the procedure
  description: Procedure duration in minute
  measure: Total abaltion time
  time frame: During the procedure
  description: Procedure duration in minute
  measure: Total X-ray exposure time
  time frame: During the procedure
  description: Total time of X-ray exposure
  measure: Total X-ray exposure dose
  time frame: During the procedure
  description: Total dose of X-ray exposure
  measure: Number of participants under general anesthesia
  time frame: During the procedure
  description: Comparison of number of patients under general anesthesia between two groups.
  measure: Evaluation of the ablation system（questionnaire）
  time frame: immediately post ablation
  description: To evaluate the stability of both systems concluded from all enrolled case using questionnaire, including below measures :
  the stability of the ablation system ;
  the usability of the ablation system .
  For each system in 1., 2., and 3., only one of the following five ratings is given:
  very stable;
  stable, inspection was unaffected;
  slightly unstable, inspection was unaffected;
  N/A.
  measure: Evaluation of the ablation catheter（questionnaire）
  time frame: immediately post ablation
  description: To evaluate the maneuvering performance of catheters in the two systems concluded from all enrolled case, including below measures :
  whether the ablation catheter can reach the expected position smoothly for ablation；
  whether the ablation catheter can be visible clearly under X-ray；
  whether the energy of the ablation catheter cannot be released after system operation
  measure: Evaluation of the adjustable introducer sheath set（questionnaire）
  time frame: immediately post ablation
  description: To evaluate the adjustable introducer sheath set of the investigation device， including below measures :
  whether the introducer sheath can reach the expected position smoothly for ablation；
  whether the introducer sheath can be visible clearly under X-ray；
  whether the curved shape of the introducer sheath can be adjustable。
  measure: incidence of composite safety endpoint
  time frame: 12 months after the ablation
  description: Composite safety endpoint composed of: death、stroke and transient ischemic attack
  measure: incidence of surgical complications
  time frame: 12 months after the ablation
  description: surgical complications composed of: Vascular puncture/bleeding complications, cardiac tamponade and/or perforation, left atrium-esophageal fistula, phrenic nerve injury, pulmonary vein stenosis, etc.
  measure: Incidence of severe adverse events
  time frame: 12 months after the ablation
  description: Refers to an event that occurs during the clinical trial that results in mortality or serious deterioration in patient health, including a fatal illness or injury, a permanent defect in body structure or body function, or an event that requires medical or surgical intervention to avoid one or more permanent defects in body structure or body function.
  measure: Incidence of device-related adverse events
  time frame: 12 months after the ablation
  description: Device-related adverse events refer to an adverse medical event related to the use of a device that occurs during the course of the clinical trial. However, a distinction should be made with respect to normal postoperative stress response, such as fever and chest and back discomfort, which, in the judgment of the investigator, need not be recorded as an adverse event. Recording of device-related adverse events will be applicable for conditions that are deemed by the investigator to be definitely related, possibly related, or of indeterminate relationship, to the test device.
  arm group label: Pulsed Field Ablation
  arm group type: Experimental
  description: PVI using the PFA system (Insight Medtech).
  arm group label: Radiofrequency Ablation
  arm group type: Active Comparator
  description: PVI using the RFA system ((Biosense Webster).
  intervention type: Device
  intervention name: Pulsed Field Ablation (PFA) Therapy
  description: Patients randomized to thePulsed Field Ablation group will undergo PVI using the PFA system (Insight Medtech).
  arm group label: Pulsed Field Ablation
  intervention type: Device
  intervention name: Radiofrequency Ablation（RAF）Therapy
  description: Patients randomized to Radiofrequency Ablation group will undergo PVI using the RFA system (Biosense Webster).
  arm group label: Radiofrequency Ablation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Yumei Xue, PhD
  phone: +86-13570082363
  email: xymgdci@163.com
  last name: Weidong Lin, PhD
  phone: +86-15914322775
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  country: China
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  mesh term: Arrhythmias, Cardiac
  sharing ipd: No