<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/NCT03276169</url>
  </required_header>
  <id_info>
    <org_study_id>xierqdoctorLAAC</org_study_id>
    <nct_id>NCT03276169</nct_id>
  </id_info>
  <brief_title>Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation</brief_title>
  <official_title>Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruiqin xie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Hebei Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one&#xD;
      year and planned to undergo surgical treatment, will be allocated into three groups. These&#xD;
      patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the&#xD;
      guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively&#xD;
      (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and&#xD;
      measurement of left ventricle(LV) and left atrial(LA) function are carried out for all&#xD;
      patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after&#xD;
      the operation. All ultrasound data will be stored and a professional director from the&#xD;
      ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography&#xD;
      include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial&#xD;
      anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e &quot;, E&#xD;
      peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial&#xD;
      strain, and strain rate. Blood samples are extracted in all patients to detect type B&#xD;
      natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the&#xD;
      operation. Blood samples are extracted in all patients to detect routine blood, coagulation,&#xD;
      D-D dimmer,Inflammatory markers (hsCRP） and other biochemical parameters before the operation&#xD;
      and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time&#xD;
      in operation LA pressure in all patients will be measured preoperatively and postoperatively.&#xD;
      This study will clarify the short-term and long-term changes of LA pressure and function of&#xD;
      patients with persistent AF after LAAC, and whether changes in left atrial pressure and&#xD;
      function are related to inflammation indicators. This study will also to observe whether the&#xD;
      coagulation indexes changed after LAAC that can be used to know whether the LAAC activates&#xD;
      the coagulation system. In addition, this study to investigate the effects of radiofrequency&#xD;
      ablation combined with LAAC on left atrial pressure and function, changes of blood&#xD;
      coagulation and inflammatory markers, and to analyze the above findings. At an average&#xD;
      follow-up of one year, changes in left atrial function, inflammation, coagulation, and&#xD;
      embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>A total of 105 patients with persistent atrial fibrillation(AF), who are persistented more than one year and planned to undergo surgical treatment, will be allocated into two groups. These patients will receive left atrial appendage closure, radiofrequency ablation under the guidance of 3D mapping and left atrial appendage closure combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The researchers will participate in the operation to record operative parameters such as LA pressure. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number. Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Left atrial function of postoperative left atrial appendage occlusion detected</measure>
    <time_frame>1-12 month</time_frame>
    <description>Transthoracic ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma biomarkers of inflammation assessed</measure>
    <time_frame>1-12 month</time_frame>
    <description>Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell，red blood cell, Platelets，neutrophile and lymphocytes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B natriuretic peptide assessed</measure>
    <time_frame>1-12 month</time_frame>
    <description>Blood samples are extracted in all patients to detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coagulation index assessed</measure>
    <time_frame>1-6 month</time_frame>
    <description>Blood samples are extracted in all patients to detected</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Left atrial appendage closure group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LAAC combined with radiofrequency ablation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Left atrial appendage closure</intervention_name>
    <description>Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography</description>
    <arm_group_label>Left atrial appendage closure group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radiofrequency ablation</intervention_name>
    <description>Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.</description>
    <arm_group_label>Radiofrequency ablation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LAAC combined with radiofrequency ablation group</intervention_name>
    <description>Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening</description>
    <arm_group_label>LAAC combined with radiofrequency ablation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persistent atrial fibrillation episode occurs in the patient that lasting longer than&#xD;
             one year,&#xD;
&#xD;
          -  atrial fibrillation cannot be prevented in patients who orally take class I and III&#xD;
             antiarrhythmic drugs,&#xD;
&#xD;
          -  and patient age is &lt;80 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with previous history of atrial fibrillation ablation, atrial thrombosis, or&#xD;
             valvular heart disease (moderate and severe valvular stenosis, severe valvular&#xD;
             regurgitation),&#xD;
&#xD;
          -  patients who underwent prosthetic heart valve replacement,&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  patients with existing liver and kidney disease, malignant tumors or hematological&#xD;
             system diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>March 17, 2021</last_update_submitted>
  <last_update_submitted_qc>March 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Second Hospital of Hebei Medical University</investigator_affiliation>
    <investigator_full_name>Ruiqin xie</investigator_full_name>
    <investigator_title>director of cardiology department</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>left atrial appendage closure</keyword>
  <keyword>left atrial function</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/NCT03276169
org study id: xierqdoctorLAAC
nct id: NCT03276169
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one
      year and planned to undergo surgical treatment, will be allocated into three groups. These
      patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the
      guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively
      (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and
      measurement of left ventricle(LV) and left atrial(LA) function are carried out for all
      patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after
      the operation. All ultrasound data will be stored and a professional director from the
      ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography
      include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial
      anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e ", E
      peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial
      strain, and strain rate. Blood samples are extracted in all patients to detect type B
      natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the
      operation. Blood samples are extracted in all patients to detect routine blood, coagulation,
      D-D dimmer,Inflammatory markers (hsCRP） and other biochemical parameters before the operation
      and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time
      in operation LA pressure in all patients will be measured preoperatively and postoperatively.
      This study will clarify the short-term and long-term changes of LA pressure and function of
      patients with persistent AF after LAAC, and whether changes in left atrial pressure and
      function are related to inflammation indicators. This study will also to observe whether the
      coagulation indexes changed after LAAC that can be used to know whether the LAAC activates
      the coagulation system. In addition, this study to investigate the effects of radiofrequency
      ablation combined with LAAC on left atrial pressure and function, changes of blood
      coagulation and inflammatory markers, and to analyze the above findings. At an average
      follow-up of one year, changes in left atrial function, inflammation, coagulation, and
      embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A total of 105 patients with persistent atrial fibrillation(AF), who are persistented more than one year and planned to undergo surgical treatment, will be allocated into two groups. These patients will receive left atrial appendage closure, radiofrequency ablation under the guidance of 3D mapping and left atrial appendage closure combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1).
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The researchers will participate in the operation to record operative parameters such as LA pressure. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number. Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.)
measure: Left atrial function of postoperative left atrial appendage occlusion detected
time frame: 1-12 month
description: Transthoracic ultrasound
measure: Plasma biomarkers of inflammation assessed
time frame: 1-12 month
description: Blood samples are extracted in all patients for the detection of the C reactive protein, white blood cell，red blood cell, Platelets，neutrophile and lymphocytes.
measure: B natriuretic peptide assessed
time frame: 1-12 month
description: Blood samples are extracted in all patients to detected
measure: Coagulation index assessed
time frame: 1-6 month
description: Blood samples are extracted in all patients to detected
arm group label: Left atrial appendage closure group
arm group type: Experimental
arm group label: Radiofrequency ablation group
arm group type: Other
arm group label: LAAC combined with radiofrequency ablation group
arm group type: Experimental
intervention type: Procedure
intervention name: Left atrial appendage closure
description: Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
arm group label: Left atrial appendage closure group
intervention type: Procedure
intervention name: Radiofrequency ablation
description: Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.
arm group label: Radiofrequency ablation group
intervention type: Procedure
intervention name: LAAC combined with radiofrequency ablation group
description: Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
arm group label: LAAC combined with radiofrequency ablation group
criteria: 
gender: All
minimum age: N/A
maximum age: 80 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: The Second Hospital of Hebei Medical University
investigator full name: Ruiqin xie
investigator title: director of cardiology department
mesh term: Atrial Fibrillation