<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/NCT03838341</url>
  </required_header>
  <id_info>
    <org_study_id>ThR-LAAO-PL</org_study_id>
    <nct_id>NCT03838341</nct_id>
  </id_info>
  <brief_title>Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrillation.</brief_title>
  <acronym>THORACS-LAAO</acronym>
  <official_title>Stand-Alone Thoracoscopic Epicardial Left Atrial Appendage Occlusion With AtriClip® Device for Thromboembolism Prevention in Nonvalvular Atrial Fibrillation - the Polish Nationwide Registry.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Polish multicenter registry to assess safety and durability of totally thoracoscopic left&#xD;
      atrial appendage occlusion for stroke prevention in atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive&#xD;
      patients with atrial fibrillation assigned for the totally thoracoscopic left atrial&#xD;
      appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The&#xD;
      registry has no limit of the number of patient included. Patients will be followed up with&#xD;
      transoesophageal echocardiography at 6-12 months to assess the durability of left atrial&#xD;
      appendage (LAA) oclusion and collect the informations about possible adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 8, 2015</start_date>
  <completion_date type="Anticipated">January 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Perioperative complications</measure>
    <time_frame>First 5 postoperative days</time_frame>
    <description>Number of perioperative complications associated with AtriClip placement</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intraoperative success of exclusion of LAA.</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Successful exclusion of LAA is defined as no communication between LAA and LA and &lt; 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac and cerebrovascular events (MACCE)</measure>
    <time_frame>5 years</time_frame>
    <description>Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications.</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>Number of participants requiring prolonged mechanical ventilation postoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any complications connected with surgical intervention</measure>
    <time_frame>Up to 30 days post operation</time_frame>
    <description>Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Stroke Prevention</condition>
  <condition>Atrial Fibrillation</condition>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>Included</arm_group_label>
    <description>The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>AtriClip™ LAA Exclusion System</intervention_name>
    <description>The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.</description>
    <arm_group_label>Included</arm_group_label>
    <other_name>AtriClip LAA Exclusion System and Delivery System (LAAØ)</other_name>
    <other_name>AtriClip LAA Exclusion System and Delivery System (PRO1)</other_name>
    <other_name>AtriClip LAA Exclusion System and Delivery System (PRO2)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral anticoagulation therapy</intervention_name>
    <description>Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.</description>
    <arm_group_label>Included</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The registry will include all patients with atrial fibrillation with high risk of&#xD;
        thromboembolic complications - CHA2DS2-VASc Score &gt;2 and HASBLED score of =&gt; 2 refered to&#xD;
        primary or secondary stroke prevention who do not require open chest surgery for other&#xD;
        reasons.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years&#xD;
&#xD;
          -  Lone atrial fibrillation&#xD;
&#xD;
          -  Previous stroke or systemic thromboembolic complications&#xD;
&#xD;
          -  High risk of thromboembolic complications assessed with CHA2DS2-VASc Score &gt;2&#xD;
&#xD;
          -  High bleeding risk assessed with HASBLED score =&gt; 2.&#xD;
&#xD;
          -  Contraindications to oral anticoagulation&#xD;
&#xD;
          -  Complications of the oral anticoagulation&#xD;
&#xD;
          -  Acceptable surgical candidate, including use of general anaesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Significant valve disease or coronary multi-vessel artery lesions requiring surgery&#xD;
&#xD;
          -  Stroke/cerebrovascular accident (CVA) within previous 30 days&#xD;
&#xD;
          -  Critical preoperative state&#xD;
&#xD;
        Intra-Operative Exclusion Criteria&#xD;
&#xD;
          -  Presence of thrombus in the left atrium or LAA as documented on intra-operative&#xD;
             transesophageal echocardiography&#xD;
&#xD;
          -  LAA tissue with significant adhesions (as evaluated by the surgeon) carries AtriClip&#xD;
             placement overly risky.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Piotr Suwalski, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Piotr Suwalski, PhD</last_name>
    <phone>+48225081269</phone>
    <email>suwalski.piotr@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anna Witkowska, MD</last_name>
    <phone>+48662076716</phone>
    <email>vera@rallywitkowscy.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw</name>
      <address>
        <city>Warsaw</city>
        <zip>02-507</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piotr Suwalski, PhD</last_name>
      <phone>+48225081269</phone>
      <email>suwalski.piotr@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Anna Witkowska, MD</last_name>
      <phone>+48662076716</phone>
      <email>vera@rallywitkowscy.pl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>February 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 2, 2019</last_update_submitted>
  <last_update_submitted_qc>March 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland</investigator_affiliation>
    <investigator_full_name>Piotr Suwalski, PhD</investigator_full_name>
    <investigator_title>Doctor of Philosophy</investigator_title>
  </responsible_party>
  <keyword>Stroke prevention</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Totally thoracoscopic</keyword>
  <keyword>LAAO</keyword>
  <keyword>AtriClip®</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/NCT03838341
org study id: ThR-LAAO-PL
nct id: NCT03838341
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Polish multicenter registry to assess safety and durability of totally thoracoscopic left
      atrial appendage occlusion for stroke prevention in atrial fibrillation.
The THORACS-LAAO Registry is the Polish multi-institutional registry of the consecutive
      patients with atrial fibrillation assigned for the totally thoracoscopic left atrial
      appendage occlusion (LAAO) for stroke prevention with designed epicardial clip AtriClip®. The
      registry has no limit of the number of patient included. Patients will be followed up with
      transoesophageal echocardiography at 6-12 months to assess the durability of left atrial
      appendage (LAA) oclusion and collect the informations about possible adverse events.
observational model: Cohort
time perspective: Prospective
measure: Perioperative complications
time frame: First 5 postoperative days
description: Number of perioperative complications associated with AtriClip placement
measure: Intraoperative success of exclusion of LAA.
time frame: Intraoperatively
description: Successful exclusion of LAA is defined as no communication between LAA and LA and < 5 mm LAA remnant measured by intraoperative transesophageal echo with Doppler.
measure: Major adverse cardiac and cerebrovascular events (MACCE)
time frame: 5 years
description: Number of Participants with combined end point of death, acute heart failure, myocardial infarction and stroke.
measure: Pulmonary complications.
time frame: Up to 30 days post operation
description: Number of participants requiring prolonged mechanical ventilation postoperatively
measure: Any complications connected with surgical intervention
time frame: Up to 30 days post operation
description: Rate of bleeding requiring transfusion or re-operation, phrenic nerve palsy, oedema requiring intervention, wound infection, abscess in pleura
arm group label: Included
description: The consecutive patients with atrial fibrillation assigned to totally thoracoscopic stand-alone left atrial appendage occlusion using AtriClip® for stroke prevention.
intervention type: Device
intervention name: AtriClip™ LAA Exclusion System
description: The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.
arm group label: Included
other name: AtriClip LAA Exclusion System and Delivery System (LAAØ)
other name: AtriClip LAA Exclusion System and Delivery System (PRO1)
other name: AtriClip LAA Exclusion System and Delivery System (PRO2)
intervention type: Drug
intervention name: Oral anticoagulation therapy
description: Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
arm group label: Included
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Piotr Suwalski, PhD
role: Principal Investigator
affiliation: Central Clinical Hospital of Ministry of the Interior and Administration in Warsaw
last name: Piotr Suwalski, PhD
phone: +48225081269
email: suwalski.piotr@gmail.com
last name: Anna Witkowska, MD
phone: +48662076716
email: vera@rallywitkowscy.pl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
investigator full name: Piotr Suwalski, PhD
investigator title: Doctor of Philosophy
mesh term: Atrial Fibrillation