<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/NCT04472871</url>
  </required_header>
  <id_info>
    <org_study_id>LAA closure in heart failure</org_study_id>
    <nct_id>NCT04472871</nct_id>
  </id_info>
  <brief_title>Feasibility and Prognosis of Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation</brief_title>
  <acronym>LAAOHF</acronym>
  <official_title>Feasibility and Prognostic Role of Percutaneous Left Atrial Appendage Closure in Patients With Heart Failure and Atrial Fibrillation at High Risk for Cerebrovascular Events</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left&#xD;
      atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher&#xD;
      rate of stroke and embolism are observed even on oral anticoagulants.&#xD;
&#xD;
      Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an&#xD;
      impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to&#xD;
      assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with&#xD;
      heart failure in preventing thromboembolic events, bleeding and all-cause mortality.&#xD;
&#xD;
      Patients will be divided into to groups, one group includes patients with no evidence of&#xD;
      heart failure, and another group including patients with previous history of or with an&#xD;
      evidence of with heart failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients selection All patients underwent left atrial appendage closure in Assiut university&#xD;
      in the period from January 2014 to December 2019 will be included.&#xD;
&#xD;
      Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with&#xD;
      previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants&#xD;
      scheduled for transcatheter left atrial appendage closure are included.&#xD;
&#xD;
      Methods In this retrospective cohort study&#xD;
&#xD;
        1. All patients with previous major bleeding or a bleeding predisposition scheduled for&#xD;
           transcatheter LAAC in Assiut university in the period from January 2014 to December 2019&#xD;
           will be included.&#xD;
&#xD;
        2. All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT&#xD;
           and Lambre)&#xD;
&#xD;
        3. CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.&#xD;
&#xD;
        4. Patients will be divided into to groups, one group includes patients with no evidence of&#xD;
           heart failure, and another group including patients with previous history of or with an&#xD;
           evidence of with heart failure.&#xD;
&#xD;
        5. Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.&#xD;
&#xD;
        6. New York Heart Association (NYHA) classification will be determined for all patient&#xD;
           graded from I-IV.&#xD;
&#xD;
        7. Both groups will be compared regarding procedural success (Procedural success is defined&#xD;
           as deployment and release of the left atrial appendage closure device into the LAA with&#xD;
           peri-device leak &lt; 5 mm), the absence of any complication related to the intervention,&#xD;
           major and minor bleeding, all-cause mortality and efficacy of the device to prevent&#xD;
           stroke, transient ischemic attack, systemic embolization during follow-up.&#xD;
&#xD;
        8. Device related thrombus (DRT) will be compared in both groups according to the results&#xD;
           of transesophageal echo (TOE) 6 weeks post procedure.&#xD;
&#xD;
      Primary endpoint&#xD;
&#xD;
      - The primary endpoints of the study are procedural success (Procedural success is defined as&#xD;
      deployment and release of the left atrial appendage closure device into the LAA with&#xD;
      peri-device leak &lt; 5 mm), the absence of any complication related to the intervention,&#xD;
      bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient&#xD;
      ischemic attack, systemic embolization during follow-up in both groups of patients with heart&#xD;
      failure and without heart failure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 20, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>procedural success</measure>
    <time_frame>6 weeks post procedure</time_frame>
    <description>procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak &lt; 5 mm) The study will assess the rate of procedural success in both groups of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the absence of any complication related to the intervention</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Device Occlusion</condition>
  <arm_group>
    <arm_group_label>patients with atrial fibrillation and heart failure</arm_group_label>
    <description>Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with atrial fibrillation without heart failure</arm_group_label>
    <description>Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Left atrial appendage closure</intervention_name>
    <description>The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.</description>
    <arm_group_label>patients with atrial fibrillation and heart failure</arm_group_label>
    <arm_group_label>patients with atrial fibrillation without heart failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients underwent left atrial appendage closure in Assiut university in the period&#xD;
        from January 2014 to December 2019 will be included.&#xD;
&#xD;
        In this retrospective cohort study, atrial fibrillation patients with previous major&#xD;
        bleeding, bleeding predisposition or contraindications for oral anticoagulants who were&#xD;
        scheduled for transcatheter left atrial appendage closure are included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In this study,&#xD;
&#xD;
               1. Atrial fibrillation patients with previous major bleeding.&#xD;
&#xD;
               2. Atrial fibrillation patients with previous bleeding predisposition&#xD;
&#xD;
               3. Atrial fibrillation patients with previous contraindications for oral&#xD;
                  anticoagulants scheduled for transcatheter left atrial appendage closure are&#xD;
                  included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having no data for follow up after the procedure&#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>Mohamed A Osman, Ass. lect.</last_name>
    <role>Study Director</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed A Osman, Ass. lect.</last_name>
    <phone>01061878040</phone>
    <email>mosman87@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hosam H Aly, Prof</last_name>
    <phone>01223971327</phone>
    <email>hosam_hasan@hotmail.com</email>
  </overall_contact_backup>
  <results_reference>
    <citation>Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.</citation>
    <PMID>23325525</PMID>
  </results_reference>
  <results_reference>
    <citation>Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.</citation>
    <PMID>26088300</PMID>
  </results_reference>
  <results_reference>
    <citation>Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.</citation>
    <PMID>29104013</PMID>
  </results_reference>
  <results_reference>
    <citation>Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.</citation>
    <PMID>29103847</PMID>
  </results_reference>
  <results_reference>
    <citation>Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.</citation>
    <PMID>27567408</PMID>
  </results_reference>
  <results_reference>
    <citation>Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13.</citation>
    <PMID>30926025</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohamed Osman Abdelhamead</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <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/NCT04472871
org study id: LAA closure in heart failure
nct id: NCT04472871
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Study hypotheses is that in patients with heart failure and atrial fibrillation, reduced left
      atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefore a higher
      rate of stroke and embolism are observed even on oral anticoagulants.

      Therefore The left atrial appendage closure (LAAC) procedure's benefit in patients with an
      impaired left ventricular ejection fraction (LVEF) has to be investigated So the study is to
      assess the safety and prognosis of left atrial appendage closure (LAAC) in patients with
      heart failure in preventing thromboembolic events, bleeding and all-cause mortality.

      Patients will be divided into to groups, one group includes patients with no evidence of
      heart failure, and another group including patients with previous history of or with an
      evidence of with heart failure.
Patients selection All patients underwent left atrial appendage closure in Assiut university
      in the period from January 2014 to December 2019 will be included.

      Inclusion criteria In this retrospective cohort study, atrial fibrillation patients with
      previous major bleeding, bleeding predisposition or contraindications for oral anticoagulants
      scheduled for transcatheter left atrial appendage closure are included.

      Methods In this retrospective cohort study

        1. All patients with previous major bleeding or a bleeding predisposition scheduled for
           transcatheter LAAC in Assiut university in the period from January 2014 to December 2019
           will be included.

        2. All devices used in for LAAC in this period will be included (WATCHMAN, Amulet, LARIAT
           and Lambre)

        3. CHA2DS2-VASC, CHADS, HAS-BLED scores will be calculated for all patients.

        4. Patients will be divided into to groups, one group includes patients with no evidence of
           heart failure, and another group including patients with previous history of or with an
           evidence of with heart failure.

        5. Heart failure will be defined as patients with left ventricular ejection fraction ≤ 35%.

        6. New York Heart Association (NYHA) classification will be determined for all patient
           graded from I-IV.

        7. Both groups will be compared regarding procedural success (Procedural success is defined
           as deployment and release of the left atrial appendage closure device into the LAA with
           peri-device leak < 5 mm), the absence of any complication related to the intervention,
           major and minor bleeding, all-cause mortality and efficacy of the device to prevent
           stroke, transient ischemic attack, systemic embolization during follow-up.

        8. Device related thrombus (DRT) will be compared in both groups according to the results
           of transesophageal echo (TOE) 6 weeks post procedure.

      Primary endpoint

      - The primary endpoints of the study are procedural success (Procedural success is defined as
      deployment and release of the left atrial appendage closure device into the LAA with
      peri-device leak < 5 mm), the absence of any complication related to the intervention,
      bleeding, all-cause mortality and efficacy of the device to prevent stroke, transient
      ischemic attack, systemic embolization during follow-up in both groups of patients with heart
      failure and without heart failure.
observational model: Cohort
time perspective: Retrospective
measure: procedural success
time frame: 6 weeks post procedure
description: procedural success (Procedural success is defined as deployment and release of the left atrial appendage closure device into the LAA with peri-device leak < 5 mm) The study will assess the rate of procedural success in both groups of the study.
measure: the absence of any complication related to the intervention
time frame: 6 months post intervention
description: Post procedural Complications including cerebrovascular stroke, bleeding and all cause mortality will be compared in both groups of the study to assess the prognosis of the procedure in these groups.
arm group label: patients with atrial fibrillation and heart failure
description: Patients with cardiac function ejection fraction less than 35% and underwent Left atrial appendage closure in the period covered by the study
arm group label: patients with atrial fibrillation without heart failure
description: Patients with cardiac function ejection fraction more than 35% and underwent Left atrial appendage closure in the period covered by the study
intervention type: Device
intervention name: Left atrial appendage closure
description: The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.
arm group label: patients with atrial fibrillation and heart failure
arm group label: patients with atrial fibrillation without heart failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohamed A Osman, Ass. lect.
role: Study Director
affiliation: Assiut University
last name: Mohamed A Osman, Ass. lect.
phone: 01061878040
email: mosman87@gmail.com
last name: Hosam H Aly, Prof
phone: 01223971327
email: hosam_hasan@hotmail.com
citation: Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.
PMID: 23325525
citation: Holmes DR Jr, Doshi SK, Kar S, Price MJ, Sanchez JM, Sievert H, Valderrabano M, Reddy VY. Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. J Am Coll Cardiol. 2015 Jun 23;65(24):2614-2623. doi: 10.1016/j.jacc.2015.04.025.
PMID: 26088300
citation: Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.
PMID: 29104013
citation: Reddy VY, Doshi SK, Kar S, Gibson DN, Price MJ, Huber K, Horton RP, Buchbinder M, Neuzil P, Gordon NT, Holmes DR Jr; PREVAIL and PROTECT AF Investigators. 5-Year Outcomes After Left Atrial Appendage Closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol. 2017 Dec 19;70(24):2964-2975. doi: 10.1016/j.jacc.2017.10.021. Epub 2017 Nov 4.
PMID: 29103847
citation: Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
PMID: 27567408
citation: Ellis CR, Kanagasundram AN. Atrial Fibrillation in Heart Failure: Left Atrial Appendage Management. Cardiol Clin. 2019 May;37(2):241-249. doi: 10.1016/j.ccl.2019.01.009. Epub 2019 Feb 13.
PMID: 30926025
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohamed Osman Abdelhamead
investigator title: Principal Investigator
mesh term: Heart Failure
mesh term: Atrial Fibrillation
sharing ipd: No