<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/NCT04403412</url>
  </required_header>
  <id_info>
    <org_study_id>XierqdoctorLAAO</org_study_id>
    <nct_id>NCT04403412</nct_id>
  </id_info>
  <brief_title>Changes of Left Atrial Function and Quality of Life in Patients With Left Atrial Appendage Occlusion</brief_title>
  <official_title>Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical&#xD;
      treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC),&#xD;
      three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency&#xD;
      ablation (1:1:1) were performed respectively. All patients were examined three-dimensional&#xD;
      and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure&#xD;
      left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein&#xD;
      were performed in all patients before operation, 1 day and 1 month after operation. B-type&#xD;
      natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3&#xD;
      months after operation. All patients underwent 6-minute walking test and quality of life&#xD;
      score before operation, 1 and 3 months after operation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical&#xD;
      treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC),&#xD;
      three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency&#xD;
      ablation (1:1:1) were performed respectively. All patients were examined by real-time&#xD;
      three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after&#xD;
      operation to measure left atrial (LA) function. All ultrasound data will be stored and the&#xD;
      professional director of the ultrasound room will be invited for quantitative analysis. The&#xD;
      ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All&#xD;
      patients underwent transesophageal echocardiography before operation and 3 months after the&#xD;
      operation. Results two experienced ultrasound doctors judged whether there was left atrial&#xD;
      thrombus, residual shunt and instrument surface related thrombus. The routine blood test and&#xD;
      high-sensitivity C-reactive protein were performed in all patients before operation, 1 day&#xD;
      and 1 month after operation. B-type natriuretic peptide was detected in all patients before&#xD;
      operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute&#xD;
      walking test and quality of life score before operation, 1 and 3 months after operation. At&#xD;
      the same time, the thickness of crista was measured in all patients. This study will clarify&#xD;
      the changes of left atrial function and biochemical quality in patients with AF after LAAC.&#xD;
      In addition, this study also observed the effect of radiofrequency ablation combined with&#xD;
      LAAC on left atrial function and evaluated whether one-stop surgery has more advantages than&#xD;
      simple occlusion or ablation, and analyzed the above results. The patients were followed up&#xD;
      for an average of three months to analyze the changes of left atrial function, quality of&#xD;
      life and embolism events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2020</start_date>
  <completion_date type="Anticipated">April 28, 2022</completion_date>
  <primary_completion_date type="Anticipated">April 28, 2022</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- 3 month</time_frame>
    <description>Transthoracic ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>changes of 6-minute walking test</measure>
    <time_frame>1- 3 month</time_frame>
    <description>6-minute walking test in meter</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life assessed</measure>
    <time_frame>1- 3 month</time_frame>
    <description>Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Residual shunt after transcatheter closure of left atrial appendage detected</measure>
    <time_frame>1-3 month</time_frame>
    <description>Transesophageal ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>device-related thrombus after transcatheter closure of left atrial appendage detected</measure>
    <time_frame>1-3 month</time_frame>
    <description>Transesophageal ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C creative protein</measure>
    <time_frame>1-3 month</time_frame>
    <description>Blood samples are extracted in all patients to detected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>B natriuretic peptide assessed</measure>
    <time_frame>before and 3 month after operation</time_frame>
    <description>Blood samples are extracted in all patients to detected</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">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>Experimental</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 group</intervention_name>
    <description>Left atrial appendage closure 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 group</intervention_name>
    <description>Radiofrequency ablation 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>LAAC combined with radiofrequency ablation group 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;
          1. Patients with AF lasting for more than one year;&#xD;
&#xD;
          2. Antiarrhythmic drugs are ineffective;&#xD;
&#xD;
          3. Age of patients is less than 80 years old;&#xD;
&#xD;
          4. Cha2ds2-vasc score ≥ 2;&#xD;
&#xD;
          5. Not suitable for long-term oral anticoagulants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of atrial thrombosis or valvular heart disease (moderate or&#xD;
             severe valve stenosis or severe valve regurgitation);&#xD;
&#xD;
          2. Patients undergoing prosthetic heart valve replacement;&#xD;
&#xD;
          3. Pregnant women;&#xD;
&#xD;
          4. Patients with previous liver and kidney diseases, malignant tumors or blood system&#xD;
             diseases.&#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 Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>ruiqin Xie, doctor</last_name>
      <phone>15803212537</phone>
      <email>13230178060@163.com</email>
    </contact>
    <contact_backup>
      <last_name>ling You, doctor</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 3, 2020</study_first_submitted>
  <study_first_submitted_qc>May 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 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>quality of life assessed</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/NCT04403412
org study id: XierqdoctorLAAO
nct id: NCT04403412
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical
      treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC),
      three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency
      ablation (1:1:1) were performed respectively. All patients were examined three-dimensional
      and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure
      left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein
      were performed in all patients before operation, 1 day and 1 month after operation. B-type
      natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3
      months after operation. All patients underwent 6-minute walking test and quality of life
      score before operation, 1 and 3 months after operation.
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical
      treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC),
      three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency
      ablation (1:1:1) were performed respectively. All patients were examined by real-time
      three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after
      operation to measure left atrial (LA) function. All ultrasound data will be stored and the
      professional director of the ultrasound room will be invited for quantitative analysis. The
      ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All
      patients underwent transesophageal echocardiography before operation and 3 months after the
      operation. Results two experienced ultrasound doctors judged whether there was left atrial
      thrombus, residual shunt and instrument surface related thrombus. The routine blood test and
      high-sensitivity C-reactive protein were performed in all patients before operation, 1 day
      and 1 month after operation. B-type natriuretic peptide was detected in all patients before
      operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute
      walking test and quality of life score before operation, 1 and 3 months after operation. At
      the same time, the thickness of crista was measured in all patients. This study will clarify
      the changes of left atrial function and biochemical quality in patients with AF after LAAC.
      In addition, this study also observed the effect of radiofrequency ablation combined with
      LAAC on left atrial function and evaluated whether one-stop surgery has more advantages than
      simple occlusion or ablation, and analyzed the above results. The patients were followed up
      for an average of three months to analyze the changes of left atrial function, quality of
      life and embolism events.
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- 3 month
description: Transthoracic ultrasound
measure: changes of 6-minute walking test
time frame: 1- 3 month
description: 6-minute walking test in meter
measure: quality of life assessed
time frame: 1- 3 month
description: Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life
measure: Residual shunt after transcatheter closure of left atrial appendage detected
time frame: 1-3 month
description: Transesophageal ultrasound
measure: device-related thrombus after transcatheter closure of left atrial appendage detected
time frame: 1-3 month
description: Transesophageal ultrasound
measure: C creative protein
time frame: 1-3 month
description: Blood samples are extracted in all patients to detected
measure: B natriuretic peptide assessed
time frame: before and 3 month after operation
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: Experimental
arm group label: LAAC combined with radiofrequency ablation group
arm group type: Experimental
intervention type: Procedure
intervention name: Left atrial appendage closure group
description: Left atrial appendage closure 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 group
description: Radiofrequency ablation 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: LAAC combined with radiofrequency ablation group 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: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
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