<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/NCT03008811</url>
  </required_header>
  <id_info>
    <org_study_id>2016/27</org_study_id>
    <nct_id>NCT03008811</nct_id>
  </id_info>
  <brief_title>Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation</brief_title>
  <acronym>NO PERS-AF</acronym>
  <official_title>Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon&#xD;
      catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment&#xD;
      of patients with persistent or longstanding persistent atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this randomized clinical trial is to compare the efficacy and safety of&#xD;
      pulmonary vein isolation with either the second generation cryoballoon (Arctic Front&#xD;
      Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter&#xD;
      (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent&#xD;
      atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation&#xD;
      treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by&#xD;
      a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia&#xD;
      recurrence at 12 months.Treatment success will be evaluated by using 12-lead&#xD;
      electrocardiography and 7-day Holter recording.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">May 2021</completion_date>
  <primary_completion_date type="Actual">April 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The freedom of any atrial arrhythmias at 12 months.</measure>
    <time_frame>12 months</time_frame>
    <description>The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration &gt; 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure duration</measure>
    <time_frame>12 months</time_frame>
    <description>Procedure duration documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy time</measure>
    <time_frame>12 months</time_frame>
    <description>Fluoroscopy time documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ablation time</measure>
    <time_frame>12 months</time_frame>
    <description>Ablation time documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life - Short Form (SF-36) Heath Survey</measure>
    <time_frame>12 months.</time_frame>
    <description>Short Form (SF-36) Heath Survey filled in by patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life affected by atrial fibrillation.</measure>
    <time_frame>12 months.</time_frame>
    <description>The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.</measure>
    <time_frame>12 months.</time_frame>
    <description>Hospitalization after the procedre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The burden of atrial fibrillation</measure>
    <time_frame>12 months.</time_frame>
    <description>Total duration of atrial fibrillation recorded by 7-day Holter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.</measure>
    <time_frame>12 months.</time_frame>
    <description>Atrial tachycardia or atrial flutter recorded by all types of ECG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms related to atrial fibrillation.</measure>
    <time_frame>12 months.</time_frame>
    <description>Symptoms related to atrial fibrillation documented</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events.</measure>
    <time_frame>12 months.</time_frame>
    <description>Serious adverse events documented</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Cryoballoon</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation with cryoballoon catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Radiofrequency</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pulmonary vein isolation with radiofrequency ablation catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein isolation with cryoballoon catheter.</intervention_name>
    <description>Device: Arctic Front Advance™ cardiac cryoablation catheter system.</description>
    <arm_group_label>Cryoballoon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein isolation with radiofrequency ablation.</intervention_name>
    <description>Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).</description>
    <arm_group_label>Radiofrequency</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients plan to undergo pulmonary vein isolation as the first procedure for&#xD;
             symptomatic persistent atrial fibrillation (&gt;7 days) and longstanding persistent&#xD;
             atrial fibrillation (&gt; 12 months, but ≤ 3 years) who are refractory to at least one&#xD;
             class I or class III antiarrhythmic drug and required at least one electrical or&#xD;
             pharmacologic cardioversion.&#xD;
&#xD;
          -  Subject is at least 18 and ≤ 75 years old.&#xD;
&#xD;
          -  Subject is able and willing to give informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Subject has paroxysmal atrial fibrillation (&lt; 7days) or persistent atrial fibrillation&#xD;
             with duration &gt; 3 years.&#xD;
&#xD;
          -  Subject has any previous left atrial ablation procedure or surgery, including&#xD;
             pulmonary vein isolation.&#xD;
&#xD;
          -  Subject has presence of an intracavitary thrombus.&#xD;
&#xD;
          -  Subject has uncontrolled heart failure.&#xD;
&#xD;
          -  Subject has severe valvular disease.&#xD;
&#xD;
          -  Subject has the left atrial diameter &gt; 60 mm confirmed by echocardiography.&#xD;
&#xD;
          -  Subject has contraindications to systemic anticoagulation with heparin or oral&#xD;
             anticoagulants.&#xD;
&#xD;
          -  Subject has known cryoglobulinaemia.&#xD;
&#xD;
          -  Subject has severe renal dysfunction.&#xD;
&#xD;
          -  Subject who is or may potentially be pregnant.&#xD;
&#xD;
          -  Subject has unstable angina pectoris.&#xD;
&#xD;
          -  Subject has history of previous myocardial infarction or percutaneous intervention&#xD;
             during the last three months.&#xD;
&#xD;
          -  Subject has chronic obstructive pulmonary disease with detected pulmonary&#xD;
             hypertension.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olavs Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Camm AJ, Obel OA. Epidemiology and mechanism of atrial fibrillation and atrial flutter. Am J Cardiol. 1996 Oct 17;78(8A):3-11. doi: 10.1016/s0002-9149(96)00559-0. No abstract available.</citation>
    <PMID>8903269</PMID>
  </reference>
  <reference>
    <citation>Biblo LA, Yuan Z, Quan KJ, Mackall JA, Rimm AA. Risk of stroke in patients with atrial flutter. Am J Cardiol. 2001 Feb 1;87(3):346-9, A9. doi: 10.1016/s0002-9149(00)01374-6.</citation>
    <PMID>11165976</PMID>
  </reference>
  <reference>
    <citation>Vidaillet H, Granada JF, Chyou Po, Maassen K, Ortiz M, Pulido JN, Sharma P, Smith PN, Hayes J. A population-based study of mortality among patients with atrial fibrillation or flutter. Am J Med. 2002 Oct 1;113(5):365-70. doi: 10.1016/s0002-9343(02)01253-6.</citation>
    <PMID>12401530</PMID>
  </reference>
  <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>
  </reference>
  <reference>
    <citation>Wolf PA, Mitchell JB, Baker CS, Kannel WB, D'Agostino RB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med. 1998 Feb 9;158(3):229-34. doi: 10.1001/archinte.158.3.229.</citation>
    <PMID>9472202</PMID>
  </reference>
  <reference>
    <citation>Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.</citation>
    <PMID>15007003</PMID>
  </reference>
  <reference>
    <citation>Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.</citation>
    <PMID>9725923</PMID>
  </reference>
  <reference>
    <citation>Verma A, Marrouche NF, Natale A. Pulmonary vein antrum isolation: intracardiac echocardiography-guided technique. J Cardiovasc Electrophysiol. 2004 Nov;15(11):1335-40. doi: 10.1046/j.1540-8167.2004.04428.x.</citation>
    <PMID>15574190</PMID>
  </reference>
  <reference>
    <citation>Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.</citation>
    <PMID>14557355</PMID>
  </reference>
  <reference>
    <citation>Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.</citation>
    <PMID>14623799</PMID>
  </reference>
  <reference>
    <citation>Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.</citation>
    <PMID>12875749</PMID>
  </reference>
  <reference>
    <citation>Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19.</citation>
    <PMID>12756153</PMID>
  </reference>
  <reference>
    <citation>Haissaguerre M, Jais P, Shah DC, Arentz T, Kalusche D, Takahashi A, Garrigue S, Hocini M, Peng JT, Clementy J. Catheter ablation of chronic atrial fibrillation targeting the reinitiating triggers. J Cardiovasc Electrophysiol. 2000 Jan;11(1):2-10. doi: 10.1111/j.1540-8167.2000.tb00727.x.</citation>
    <PMID>10695453</PMID>
  </reference>
  <reference>
    <citation>Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.</citation>
    <PMID>25220575</PMID>
  </reference>
  <reference>
    <citation>Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.</citation>
    <PMID>25946280</PMID>
  </reference>
  <reference>
    <citation>Liu J, Kaufmann J, Kriatselis C, Fleck E, Gerds-Li JH. Second generation of cryoballoons can improve efficiency of cryoablation for atrial fibrillation. Pacing Clin Electrophysiol. 2015 Jan;38(1):129-35. doi: 10.1111/pace.12538. Epub 2014 Dec 12.</citation>
    <PMID>25494851</PMID>
  </reference>
  <reference>
    <citation>Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.</citation>
    <PMID>25186456</PMID>
  </reference>
  <reference>
    <citation>Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Storti C, Montenero AS, Chierchia GB, Brugada P. Pulmonary vein isolation as index procedure for persistent atrial fibrillation: One-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm. 2015 Jan;12(1):60-6. doi: 10.1016/j.hrthm.2014.09.063. Epub 2014 Oct 2.</citation>
    <PMID>25281891</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Catheter Ablation</keyword>
  <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/NCT03008811
org study id: 2016/27
nct id: NCT03008811
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon
      catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment
      of patients with persistent or longstanding persistent atrial fibrillation.
The purpose of this randomized clinical trial is to compare the efficacy and safety of
      pulmonary vein isolation with either the second generation cryoballoon (Arctic Front
      Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter
      (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent
      atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation
      treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by
      a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia
      recurrence at 12 months.Treatment success will be evaluated by using 12-lead
      electrocardiography and 7-day Holter recording.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The freedom of any atrial arrhythmias at 12 months.
time frame: 12 months
description: The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording).
measure: Procedure duration
time frame: 12 months
description: Procedure duration documented
measure: Fluoroscopy time
time frame: 12 months
description: Fluoroscopy time documented
measure: Ablation time
time frame: 12 months
description: Ablation time documented
measure: Quality of life - Short Form (SF-36) Heath Survey
time frame: 12 months.
description: Short Form (SF-36) Heath Survey filled in by patients.
measure: Quality of life affected by atrial fibrillation.
time frame: 12 months.
description: The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients.
measure: Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias.
time frame: 12 months.
description: Hospitalization after the procedre
measure: The burden of atrial fibrillation
time frame: 12 months.
description: Total duration of atrial fibrillation recorded by 7-day Holter.
measure: The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter.
time frame: 12 months.
description: Atrial tachycardia or atrial flutter recorded by all types of ECG
measure: Symptoms related to atrial fibrillation.
time frame: 12 months.
description: Symptoms related to atrial fibrillation documented
measure: Serious adverse events.
time frame: 12 months.
description: Serious adverse events documented
arm group label: Cryoballoon
arm group type: Active Comparator
description: Pulmonary vein isolation with cryoballoon catheter.
arm group label: Radiofrequency
arm group type: Active Comparator
description: Pulmonary vein isolation with radiofrequency ablation catheter.
intervention type: Procedure
intervention name: Pulmonary vein isolation with cryoballoon catheter.
description: Device: Arctic Front Advance™ cardiac cryoablation catheter system.
arm group label: Cryoballoon
intervention type: Procedure
intervention name: Pulmonary vein isolation with radiofrequency ablation.
description: Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
arm group label: Radiofrequency
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Norway
citation: Camm AJ, Obel OA. Epidemiology and mechanism of atrial fibrillation and atrial flutter. Am J Cardiol. 1996 Oct 17;78(8A):3-11. doi: 10.1016/s0002-9149(96)00559-0. No abstract available.
PMID: 8903269
citation: Biblo LA, Yuan Z, Quan KJ, Mackall JA, Rimm AA. Risk of stroke in patients with atrial flutter. Am J Cardiol. 2001 Feb 1;87(3):346-9, A9. doi: 10.1016/s0002-9149(00)01374-6.
PMID: 11165976
citation: Vidaillet H, Granada JF, Chyou Po, Maassen K, Ortiz M, Pulido JN, Sharma P, Smith PN, Hayes J. A population-based study of mortality among patients with atrial fibrillation or flutter. Am J Med. 2002 Oct 1;113(5):365-70. doi: 10.1016/s0002-9343(02)01253-6.
PMID: 12401530
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: Wolf PA, Mitchell JB, Baker CS, Kannel WB, D'Agostino RB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med. 1998 Feb 9;158(3):229-34. doi: 10.1001/archinte.158.3.229.
PMID: 9472202
citation: Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.
PMID: 15007003
citation: Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
PMID: 9725923
citation: Verma A, Marrouche NF, Natale A. Pulmonary vein antrum isolation: intracardiac echocardiography-guided technique. J Cardiovasc Electrophysiol. 2004 Nov;15(11):1335-40. doi: 10.1046/j.1540-8167.2004.04428.x.
PMID: 15574190
citation: Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
PMID: 14557355
citation: Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.
PMID: 14623799
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responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No