<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/NCT03816410</url>
  </required_header>
  <id_info>
    <org_study_id>SR-345-DP</org_study_id>
    <nct_id>NCT03816410</nct_id>
  </id_info>
  <brief_title>Natriuretic Peptides After Left Atrial Appendage Amputation</brief_title>
  <official_title>Influence of Left Atrial Appendage Amputation on Natriuretic Peptides - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</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>
      Surgical amputation of the left atrial appendage (LAA) is an established intervention during&#xD;
      surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of&#xD;
      the left atrium are unclear. This study aims to quantify the serum levels of natriuretic&#xD;
      peptides in patients who undergo concomitant surgical AF ablation with or without LAA&#xD;
      amputation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2015</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2015</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>1:1 Randomization</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum levels of proANP and BNP until 800days post surgery</measure>
    <time_frame>800days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LAA amputation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>No LAA amputation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LAA amputation</intervention_name>
    <description>complete surgical amputation of the left atrial appendage</description>
    <arm_group_label>LAA amputation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for concomitant AF therapy during cardiac surgery with cardiopulmonary&#xD;
             bypass&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Adult and Pediatric Cardiovascular Surgery</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT03816410
org study id: SR-345-DP
nct id: NCT03816410
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical amputation of the left atrial appendage (LAA) is an established intervention during
      surgical atrial fibrillation (AF) therapy. However, its effects on the endocrine function of
      the left atrium are unclear. This study aims to quantify the serum levels of natriuretic
      peptides in patients who undergo concomitant surgical AF ablation with or without LAA
      amputation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 1:1 Randomization
primary purpose: Screening
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Serum levels of proANP and BNP until 800days post surgery
time frame: 800days
arm group label: LAA amputation group
arm group type: Experimental
arm group label: No LAA amputation group
arm group type: No Intervention
intervention type: Procedure
intervention name: LAA amputation
description: complete surgical amputation of the left atrial appendage
arm group label: LAA amputation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No