<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/NCT03788941</url>
  </required_header>
  <id_info>
    <org_study_id>XH-18-015</org_study_id>
    <nct_id>NCT03788941</nct_id>
  </id_info>
  <brief_title>Left Atrial Appendage Closure in Combination With Catheter Ablation</brief_title>
  <acronym>LAACablation</acronym>
  <official_title>The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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>
      This study is a prospective cohort study aimed at investigating the efficacy and safety of&#xD;
      left atrial appendage closure in combination with catheter ablation in patients with atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective cohort investigating the efficacy and safety of catheter ablation&#xD;
      in combination with left atrial appendage closure in patients with atrial fibrillation.&#xD;
&#xD;
      This study will be conducted in accordance with the following procedures:&#xD;
&#xD;
        1. Screen out patients in accordance with the inclusion and exclusion criteria. The&#xD;
           following assessments should be made: demographic data, medical history, physical&#xD;
           examination, vital signs data, the height and body weight, laboratory parameters, ECG&#xD;
           examination, assessment for medication and evaluation for inclusion/exclusion criteria.&#xD;
&#xD;
        2. Participants receive radiofrequency ablation in combination with left atrial appendage&#xD;
           closure. Participants will be assessed and observed carefully during and after the&#xD;
           operation.&#xD;
&#xD;
        3. The participants will be followed-up in the third, ninth and twelfth months after the&#xD;
           treatments. The main follow-up includes the review of ECG, 24h Holter monitoring,&#xD;
           echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT&#xD;
           questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms&#xD;
           will also be observed and recorded. The incidence of stroke, systemic embolism,&#xD;
           transient ischemic attack, major bleeding and all-cause death; the rate of patients&#xD;
           maintaining sinus rhythm, hospitalization due to heart failure, and perioperative&#xD;
           complications such as pericardial tamponade, wound hematoma and long-term&#xD;
           surgery-related complications will be recorded. Adverse events during the trial will&#xD;
           also be assessed and recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>stroke/TIA/systemic embolism</measure>
    <time_frame>long-term after the procedure.</time_frame>
    <description>The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Major bleeding</measure>
    <time_frame>long-term after the procedure.</time_frame>
    <description>The incidence of major bleeding in the participants will be reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>long-term after the procedure.</time_frame>
    <description>all-cause death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>maintenance of sinus rhythm</measure>
    <time_frame>after the procedure outside the 3-month blanking period</time_frame>
    <description>This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedure-related complications</measure>
    <time_frame>after the procedure.</time_frame>
    <description>These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure rehospitalization</measure>
    <time_frame>after the procedure.</time_frame>
    <description>acute heart failure leading to hospitalization</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Atrial fibrillation effects on quality-of-life (AFEQT) scores</measure>
    <time_frame>at baseline and after the procedure</time_frame>
    <description>At baseline and at the 1-year follow-up visit, patients were required to complete a 20-item questionnaire based on the AF effects on quality-of-life (QoL) (AFEQT, http://www.afeqt.org) measure. The 20-item AFEQT survey evaluated 4 domains regarding the QoL assessment and the perception of treatment, i.e., symptoms, daily activities, treatment-related concerns, and treatment satisfaction. The first three domains constituted the global score. The scores of each individual domain and the global score ranged between 0 and 100, with &quot;100&quot; representing the best health status and &quot;0&quot; being the worst health status possible. A validated culturally and linguistically translated version of the AFEQT for China was used.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LAAC plus Catheter ablation</arm_group_label>
    <description>Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>left atrial appendage closure and catheter ablation</intervention_name>
    <description>Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).&#xD;
Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.</description>
    <arm_group_label>LAAC plus Catheter ablation</arm_group_label>
    <other_name>left atrial appendage occlusion; radiofrequency ablation</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The investigators will only harvest whole blood to determine the biomarkers of heart failure&#xD;
      and inflammation in the plasma. The investigators will not retain any tissue or other&#xD;
      specimens or extract DNA from tissues or plasma.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation&#xD;
&#xD;
          2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term&#xD;
             antiarrhythmic drugs;&#xD;
&#xD;
          3. With contraindication of longterm anticoagulation or unwilling to receive longterm&#xD;
             anticoagulation&#xD;
&#xD;
          4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3&#xD;
&#xD;
          5. Provide informed consent to participate in the study;&#xD;
&#xD;
          6. Between 18-90 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation&#xD;
&#xD;
          2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term&#xD;
             antiarrhythmic drugs;&#xD;
&#xD;
          3. With contraindication of longterm anticoagulation or unwilling to receive longterm&#xD;
             anticoagulation&#xD;
&#xD;
          4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3&#xD;
&#xD;
          5. Provide informed consent to participate in the study;&#xD;
&#xD;
          6. Between 18-90 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. myocardial infarction within 3 months&#xD;
&#xD;
          2. Stroke or systemic embolism within 3 months&#xD;
&#xD;
          3. Plan to receive heart transplantation;&#xD;
&#xD;
          4. Life expectancy less than 1 year;&#xD;
&#xD;
          5. Severe bleeding diseases that cannot be treated with short-term anticoagulants;&#xD;
&#xD;
          6. With left atrial or left atrial appendage thrombus;&#xD;
&#xD;
          7. With uncontrolled malignant tumor ;&#xD;
&#xD;
          8. Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of&#xD;
             normal, or CCr &lt;50%);&#xD;
&#xD;
          9. Women who are pregnant, or breastfeeding.&#xD;
&#xD;
         10. Other conditions not suitable to the combined procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Gang Li, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiaotong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mu Chen, Dr.</last_name>
    <phone>86 021 25077275</phone>
    <email>chenmu@xinhuamed.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xinhua Hospital, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mu Chen</last_name>
      <phone>+86 021 25077275</phone>
      <email>chenmu@xinhuamed.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.</citation>
    <PMID>23982711</PMID>
  </results_reference>
  <results_reference>
    <citation>Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc. 2015 Jan 21;4(1):e001486. doi: 10.1161/JAHA.114.001486.</citation>
    <PMID>25609415</PMID>
  </results_reference>
  <results_reference>
    <citation>Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.</citation>
    <PMID>9737513</PMID>
  </results_reference>
  <results_reference>
    <citation>Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.</citation>
    <PMID>12401529</PMID>
  </results_reference>
  <results_reference>
    <citation>Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.</citation>
    <PMID>23321349</PMID>
  </results_reference>
  <results_reference>
    <citation>Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.</citation>
    <PMID>27029350</PMID>
  </results_reference>
  <results_reference>
    <citation>Hu H, Cui K, Jiang J, Fu H, Zeng R. Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation. Pacing Clin Electrophysiol. 2018 Jan;41(1):28-34. doi: 10.1111/pace.13250. Epub 2017 Dec 28.</citation>
    <PMID>29194654</PMID>
  </results_reference>
  <results_reference>
    <citation>Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.</citation>
    <PMID>29106523</PMID>
  </results_reference>
  <results_reference>
    <citation>Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm. 2004 Nov;1(5):576-81. doi: 10.1016/j.hrthm.2004.07.020.</citation>
    <PMID>15851222</PMID>
  </results_reference>
  <results_reference>
    <citation>Perea RJ, Tamborero D, Mont L, De Caralt TM, Ortiz JT, Berruezo A, Matiello M, Sitges M, Vidal B, Sanchez M, Brugada J. Left atrial contractility is preserved after successful circumferential pulmonary vein ablation in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2008 Apr;19(4):374-9. doi: 10.1111/j.1540-8167.2007.01086.x. Epub 2008 Feb 4.</citation>
    <PMID>18266672</PMID>
  </results_reference>
  <results_reference>
    <citation>Luani B, Groscheck T, Genz C, Tanev I, Rauwolf T, Herold J, Medunjanin S, Schmeisser A, Braun-Dullaeus RC. Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN-device. BMC Cardiovasc Disord. 2017 Dec 12;17(1):294. doi: 10.1186/s12872-017-0728-6.</citation>
    <PMID>29233088</PMID>
  </results_reference>
  <results_reference>
    <citation>Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186.</citation>
    <PMID>24998121</PMID>
  </results_reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</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>Undecided</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/NCT03788941
org study id: XH-18-015
nct id: NCT03788941
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a prospective cohort study aimed at investigating the efficacy and safety of
      left atrial appendage closure in combination with catheter ablation in patients with atrial
      fibrillation.
This study is a prospective cohort investigating the efficacy and safety of catheter ablation
      in combination with left atrial appendage closure in patients with atrial fibrillation.

      This study will be conducted in accordance with the following procedures:

        1. Screen out patients in accordance with the inclusion and exclusion criteria. The
           following assessments should be made: demographic data, medical history, physical
           examination, vital signs data, the height and body weight, laboratory parameters, ECG
           examination, assessment for medication and evaluation for inclusion/exclusion criteria.

        2. Participants receive radiofrequency ablation in combination with left atrial appendage
           closure. Participants will be assessed and observed carefully during and after the
           operation.

        3. The participants will be followed-up in the third, ninth and twelfth months after the
           treatments. The main follow-up includes the review of ECG, 24h Holter monitoring,
           echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT
           questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms
           will also be observed and recorded. The incidence of stroke, systemic embolism,
           transient ischemic attack, major bleeding and all-cause death; the rate of patients
           maintaining sinus rhythm, hospitalization due to heart failure, and perioperative
           complications such as pericardial tamponade, wound hematoma and long-term
           surgery-related complications will be recorded. Adverse events during the trial will
           also be assessed and recorded.
observational model: Cohort
time perspective: Prospective
measure: stroke/TIA/systemic embolism
time frame: long-term after the procedure.
description: The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.
measure: Major bleeding
time frame: long-term after the procedure.
description: The incidence of major bleeding in the participants will be reported.
measure: Death
time frame: long-term after the procedure.
description: all-cause death
measure: maintenance of sinus rhythm
time frame: after the procedure outside the 3-month blanking period
description: This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias.
measure: procedure-related complications
time frame: after the procedure.
description: These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications.
measure: Heart failure rehospitalization
time frame: after the procedure.
description: acute heart failure leading to hospitalization
measure: Atrial fibrillation effects on quality-of-life (AFEQT) scores
time frame: at baseline and after the procedure
description: At baseline and at the 1-year follow-up visit, patients were required to complete a 20-item questionnaire based on the AF effects on quality-of-life (QoL) (AFEQT, http://www.afeqt.org) measure. The 20-item AFEQT survey evaluated 4 domains regarding the QoL assessment and the perception of treatment, i.e., symptoms, daily activities, treatment-related concerns, and treatment satisfaction. The first three domains constituted the global score. The scores of each individual domain and the global score ranged between 0 and 100, with "100" representing the best health status and "0" being the worst health status possible. A validated culturally and linguistically translated version of the AFEQT for China was used.
arm group label: LAAC plus Catheter ablation
description: Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.
intervention type: Procedure
intervention name: left atrial appendage closure and catheter ablation
description: Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).
Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.
arm group label: LAAC plus Catheter ablation
other name: left atrial appendage occlusion; radiofrequency ablation
The investigators will only harvest whole blood to determine the biomarkers of heart failure
      and inflammation in the plasma. The investigators will not retain any tissue or other
      specimens or extract DNA from tissues or plasma.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yi-Gang Li, Dr.
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiaotong University School of Medicine
last name: Mu Chen, Dr.
phone: 86 021 25077275
email: chenmu@xinhuamed.com.cn
facility: 
status: Recruiting
contact: 
country: China
citation: Bjorck S, Palaszewski B, Friberg L, Bergfeldt L. Atrial fibrillation, stroke risk, and warfarin therapy revisited: a population-based study. Stroke. 2013 Nov;44(11):3103-8. doi: 10.1161/STROKEAHA.113.002329. Epub 2013 Aug 27.
PMID: 23982711
citation: Haim M, Hoshen M, Reges O, Rabi Y, Balicer R, Leibowitz M. Prospective national study of the prevalence, incidence, management and outcome of a large contemporary cohort of patients with incident non-valvular atrial fibrillation. J Am Heart Assoc. 2015 Jan 21;4(1):e001486. doi: 10.1161/JAHA.114.001486.
PMID: 25609415
citation: Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
PMID: 9737513
citation: Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.
PMID: 12401529
citation: Andersson T, Magnuson A, Bryngelsson IL, Frobert O, Henriksson KM, Edvardsson N, Poci D. All-cause mortality in 272,186 patients hospitalized with incident atrial fibrillation 1995-2008: a Swedish nationwide long-term case-control study. Eur Heart J. 2013 Apr;34(14):1061-7. doi: 10.1093/eurheartj/ehs469. Epub 2013 Jan 14.
PMID: 23321349
citation: Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30.
PMID: 27029350
citation: Hu H, Cui K, Jiang J, Fu H, Zeng R. Safety and efficacy analysis of one-stop intervention for treating nonvalvular atrial fibrillation. Pacing Clin Electrophysiol. 2018 Jan;41(1):28-34. doi: 10.1111/pace.13250. Epub 2017 Dec 28.
PMID: 29194654
citation: Phillips KP, Pokushalov E, Romanov A, Artemenko S, Folkeringa RJ, Szili-Torok T, Senatore G, Stein KM, Razali O, Gordon N, Boersma LVA. Combining Watchman left atrial appendage closure and catheter ablation for atrial fibrillation: multicentre registry results of feasibility and safety during implant and 30 days follow-up. Europace. 2018 Jun 1;20(6):949-955. doi: 10.1093/europace/eux183.
PMID: 29106523
citation: Lemola K, Sneider M, Desjardins B, Case I, Chugh A, Hall B, Cheung P, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Kazerooni E, Morady F, Oral H. Effects of left atrial ablation of atrial fibrillation on size of the left atrium and pulmonary veins. Heart Rhythm. 2004 Nov;1(5):576-81. doi: 10.1016/j.hrthm.2004.07.020.
PMID: 15851222
citation: Perea RJ, Tamborero D, Mont L, De Caralt TM, Ortiz JT, Berruezo A, Matiello M, Sitges M, Vidal B, Sanchez M, Brugada J. Left atrial contractility is preserved after successful circumferential pulmonary vein ablation in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2008 Apr;19(4):374-9. doi: 10.1111/j.1540-8167.2007.01086.x. Epub 2008 Feb 4.
PMID: 18266672
citation: Luani B, Groscheck T, Genz C, Tanev I, Rauwolf T, Herold J, Medunjanin S, Schmeisser A, Braun-Dullaeus RC. Left atrial enlargement and clinical considerations in patients with or without a residual interatrial shunt after closure of the left atrial appendage with the WATCHMAN-device. BMC Cardiovasc Disord. 2017 Dec 12;17(1):294. doi: 10.1186/s12872-017-0728-6.
PMID: 29233088
citation: Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. Erratum In: J Am Coll Cardiol. 2014 Sep 16;64(11):1186.
PMID: 24998121
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: Undecided