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/NCT06039722</url>
    </required_header>
    <id_info>
      <org_study_id>PMTCT2022001</org_study_id>
      <nct_id>NCT06039722</nct_id>
    </id_info>
    <brief_title>Clinical Trial of the Pulse Field Ablation System for the Treatment of Paroxysmal Atrial Fibrillation in 11 Centers in China</brief_title>
    <official_title>Prospective, Multicenter, Single-arm Clinical Trial Evaluating the Safety and Efficacy of the Pulse Field Ablation System in Combination With the Pulse Field Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shenzhen Pulsecare Medical Technology Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shenzhen Pulsecare Medical Technology Co., Ltd.</source>
    <oversight_info>
      <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 expected to include 166 subjects and Conducted at 11 research centers；The&#xD;
        expected 12 month treatment success rate of using research instruments is 65%.&#xD;
  &#xD;
        Principle evaluation indexes：&#xD;
  &#xD;
          1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary&#xD;
             vein electrical isolation was achieved after ablation.&#xD;
  &#xD;
          2. Immediate success rate of surgery=number of patients with immediate success of&#xD;
             surgery/number of cases in subjects × 100%&#xD;
  &#xD;
          3. Treatment success rate at 12 months after surgery Treatment success: Between 3 months&#xD;
             and 12 months after ablation, there were no episodes of atrial fibrillation/atrial&#xD;
             flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram&#xD;
             confirmation) without the use of antiarrhythmic drugs.&#xD;
  &#xD;
        Treatment success rate=number of successful cases of postoperative treatment in&#xD;
        subjects/number of cases in subjects × 100%&#xD;
  &#xD;
        Secondary evaluation indexes：&#xD;
  &#xD;
          1. The occurrence of hospitalization or emergency treatment due to symptoms caused by&#xD;
             atrial arrhythmias during follow-up at 6 and 12 months after surgery;&#xD;
  &#xD;
          2. Device performance evaluation;&#xD;
  &#xD;
        Safety evaluation indexes：&#xD;
  &#xD;
          1. The occurrence of death, stroke, or transient ischemic attack;&#xD;
  &#xD;
          2. The occurrence of surgical related complications, such as vascular puncture&#xD;
             complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial&#xD;
             esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;&#xD;
  &#xD;
          3. Clinically significant vital signs and related examinations;&#xD;
  &#xD;
          4. The occurrence of other adverse events and serious adverse events during the trial&#xD;
             period.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">November 3, 2022</start_date>
    <completion_date type="Anticipated">August 17, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 17, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Immediate success rate of surgery</measure>
      <time_frame>After surgery 20 minutes later</time_frame>
      <description>Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.&#xD;
  Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.&#xD;
  Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.&#xD;
  Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Treatment success rate</measure>
      <time_frame>Between 3 months and 12 months after ablation</time_frame>
      <description>Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.&#xD;
  Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>numer of cases of the the occurrence of hospitalization or emergency treatment</measure>
      <time_frame>Between 0 months and 12 months after ablation</time_frame>
      <description>The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Device performance evaluation</measure>
      <time_frame>surgery period</time_frame>
      <description>Device defects of the clinical trial equipment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">166</enrollment>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each subject underwent pulse ablation catheter ablation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Pulse ablation catheter</intervention_name>
      <description>Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects must meet all of the following conditions to be enrolled:&#xD;
  &#xD;
            1. 18 to 80 years of age, gender is not limited&#xD;
  &#xD;
            2. Patients with a clinical diagnosis of paroxysmal atrial fibrillation confirmed by ECG&#xD;
  &#xD;
            3. Patients who were to undergo catheter ablation of atrial fibrillation&#xD;
  &#xD;
            4. Those who agreed to participate in this study and voluntarily signed the informed&#xD;
               consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Subjects were excluded if they met one of the following conditions:&#xD;
  &#xD;
            1. Patients who have had ablation for atrial fibrillation&#xD;
  &#xD;
            2. Patients with left ventricular ejection fraction (LVEF) &lt;35%.&#xD;
  &#xD;
            3. Patients with an anteroposterior diameter of the left atrium (echocardiography) &gt;50 mm&#xD;
  &#xD;
            4. Preoperative detection of a definite thrombus in the left atrium&#xD;
  &#xD;
            5. Patients with cardiac function class (NYHA) III-IV&#xD;
  &#xD;
            6. Patients with second-degree (type II) or third-degree atrioventricular block&#xD;
  &#xD;
            7. Patients with significant congenital heart defects (including atrial septal defect,&#xD;
               ventricular septal defect, arterial ductus arteriosus, transposition ofthe grea, or&#xD;
               severe pulmonicvalve, but not including foramen ovale persistens)&#xD;
  &#xD;
            8. Patients with implanted prosthetic valves or the presence of severe heart valve&#xD;
               disease, who are not suitable for ablation for atrial fibrillation&#xD;
  &#xD;
            9. Patients with artificial cardiac pacemaker or implantable cardioverter defibrillator&#xD;
               (ICDs)&#xD;
  &#xD;
           10. Patients diagnosed with hypertrophic obstructive cardiomyopathy, chronic obstructive&#xD;
               pulmonary disease, or myxoma&#xD;
  &#xD;
           11. Patients who need to undergo left atrial appendage closure in the same surgery&#xD;
  &#xD;
           12. Patients found to have atrial flutter preoperatively and judged unsuitable by the&#xD;
               investigators, or patients with atrial parasystolic tachycardia (non-pulmonary venous&#xD;
               origin) or paroxysmal supraventricular tachycardia&#xD;
  &#xD;
           13. Patients with active systemic infection who are judged unsuitable for interventional&#xD;
               therapy by the investigators&#xD;
  &#xD;
           14. Patients with systemic bleeding tendencies that preclude surgery or patients with&#xD;
               renal failure undergoing hemodialysis&#xD;
  &#xD;
           15. Patients who have had a myocardial infarction or any interventional/open heart surgery&#xD;
               (except coronary angiography) within 3 months&#xD;
  &#xD;
           16. Patients who have had a stroke (except asymptomatic stroke) or transient ischemic&#xD;
               attack within 3 months&#xD;
  &#xD;
           17. Patients with significant contraindications to interventional procedures or with an&#xD;
               expected survival of &lt;1 year who are judged by the investigator to be incapable of&#xD;
               undergoing ablative procedures&#xD;
  &#xD;
           18. Females who are pregnant or breastfeeding or who are planning to have children during&#xD;
               the study period&#xD;
  &#xD;
           19. Patients who have participated in a clinical trial of another drug or medical device&#xD;
               within 3 months&#xD;
  &#xD;
           20. Patients who, in the opinion of the investigator, are not suitable for participation&#xD;
               in this clinical trial&#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>the Second Affiliated Hospital of Sun Yat-sen University （Sun Yat-sen Memorial Hospital）</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510120</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pulse Field Ablation Catheter</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</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/NCT06039722
  org study id: PMTCT2022001
  nct id: NCT06039722
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is expected to include 166 subjects and Conducted at 11 research centers；The
        expected 12 month treatment success rate of using research instruments is 65%.
  
        Principle evaluation indexes：
  
          1. Immediate success rate of surgery Immediately success of the surgery: complete pulmonary
             vein electrical isolation was achieved after ablation.
  
          2. Immediate success rate of surgery=number of patients with immediate success of
             surgery/number of cases in subjects × 100%
  
          3. Treatment success rate at 12 months after surgery Treatment success: Between 3 months
             and 12 months after ablation, there were no episodes of atrial fibrillation/atrial
             flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram
             confirmation) without the use of antiarrhythmic drugs.
  
        Treatment success rate=number of successful cases of postoperative treatment in
        subjects/number of cases in subjects × 100%
  
        Secondary evaluation indexes：
  
          1. The occurrence of hospitalization or emergency treatment due to symptoms caused by
             atrial arrhythmias during follow-up at 6 and 12 months after surgery;
  
          2. Device performance evaluation;
  
        Safety evaluation indexes：
  
          1. The occurrence of death, stroke, or transient ischemic attack;
  
          2. The occurrence of surgical related complications, such as vascular puncture
             complications (pseudoaneurysm, arteriovenous fistula, etc.), heart perforation, atrial
             esophageal fistula, phrenic nerve injury, pulmonary vein stenosis (symptomatic), etc;
  
          3. Clinically significant vital signs and related examinations;
  
          4. The occurrence of other adverse events and serious adverse events during the trial
             period.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Immediate success rate of surgery
  time frame: After surgery 20 minutes later
  description: Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
  Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
  Immediate success rate of surgery Immediately success of the surgery: complete pulmonary vein electrical isolation was achieved after ablation.
  Immediate success rate of surgery=number of patients with immediate success of surgery/number of cases in subjects × 100%
  measure: Treatment success rate
  time frame: Between 3 months and 12 months after ablation
  description: Treatment success rate at 12 months after surgery Treatment success: Between 3 months and 12 months after ablation, there were no episodes of atrial fibrillation/atrial flutter/atrial tachycardia (duration ≥ 30 seconds, with clear electrocardiogram confirmation) without the use of antiarrhythmic drugs.
  Treatment success rate=number of successful cases of postoperative treatment in subjects/number of cases in subjects × 100%
  measure: numer of cases of the the occurrence of hospitalization or emergency treatment
  time frame: Between 0 months and 12 months after ablation
  description: The occurrence of hospitalization or emergency treatment due to symptoms caused by atrial arrhythmias during follow-up at 6 and 12 months after surgery;
  measure: Device performance evaluation
  time frame: surgery period
  description: Device defects of the clinical trial equipment
  arm group label: experimental group
  arm group type: Experimental
  description: Each subject underwent pulse ablation catheter ablation
  intervention type: Device
  intervention name: Pulse ablation catheter
  description: Pulse ablation catheter is used to ablate the junction of left atrium and pulmonary vein, removing pulmonary vein potential
  arm group label: experimental group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  sharing ipd: No