<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/NCT03239262</url>
  </required_header>
  <id_info>
    <org_study_id>FNO-Cardiosurgery-1</org_study_id>
    <nct_id>NCT03239262</nct_id>
  </id_info>
  <brief_title>Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation</brief_title>
  <official_title>Assessment of the Effect of Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation in Patients Undergoing Open Heart Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</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>
      The aim of our study was to investigate, whether enhancement of left atrial cryoablation by&#xD;
      ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of&#xD;
      surgical treatment of atrial fibrillation in patients with structural heart disease&#xD;
      undergoing open-heart surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The observed patient file consisted of 100 patients, who have undergone a combined open-heart&#xD;
      surgery at our department between July 2012 and December 2014. The patients were indicated&#xD;
      for the surgical procedure due to structural heart disease, and suffered from paroxysmal,&#xD;
      persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial&#xD;
      cryoablation was performed in the extent of isolation of pulmonary veins, box lesion,&#xD;
      connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting&#xD;
      lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the&#xD;
      patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with&#xD;
      decision and ablation of the ligament of Marshall.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2012</start_date>
  <completion_date type="Actual">February 28, 2016</completion_date>
  <primary_completion_date type="Actual">January 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two groups of patients undergoing standard treatment have been compared retrospectively.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sinus Rhythm</measure>
    <time_frame>30 months</time_frame>
    <description>The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery</measure>
    <time_frame>30 months</time_frame>
    <description>The secondary outcome was the detection of relationship between the recurrence of atrial fibrillation and the presence of a mitral valve surgery, the presence of a mitral and tricuspid valves surgery and the left atrium diameter &gt;50 mm.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Mitral Valve Disease</condition>
  <condition>Coronary Artery Disease</condition>
  <condition>Tricuspid Valve Disease</condition>
  <condition>Aortic Valve Disease</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Group GP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group LA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Concomitant Mapping and Radiofrequency Ablation</intervention_name>
    <description>Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall.&#xD;
GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure&gt;20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.</description>
    <arm_group_label>Group GP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention was performed in patients without ganglionated plexi.</description>
    <arm_group_label>Group LA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve&#xD;
             disease and/or aortic valve disease and/or coronary artery disease and/or other)&#xD;
&#xD;
          -  Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation&#xD;
&#xD;
          -  Signing of the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 40 and over 80 years of age&#xD;
&#xD;
          -  Left ventricular ejection fraction below 25%&#xD;
&#xD;
          -  Left atrium diameter over 60mm&#xD;
&#xD;
          -  Permanent atrial fibrillation&#xD;
&#xD;
          -  Polymorbidity (Euroscore II over 10)&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Renal insufficiency (creatinine over 200 umol/l)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiri Barta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radim Brat, MD,PhD,MBA</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <reference>
    <citation>Hou Y, Scherlag BJ, Lin J, Zhang Y, Lu Z, Truong K, Patterson E, Lazzara R, Jackman WM, Po SS. Ganglionated plexi modulate extrinsic cardiac autonomic nerve input: effects on sinus rate, atrioventricular conduction, refractoriness, and inducibility of atrial fibrillation. J Am Coll Cardiol. 2007 Jul 3;50(1):61-8. doi: 10.1016/j.jacc.2007.02.066. Epub 2007 Jun 18.</citation>
    <PMID>17601547</PMID>
  </reference>
  <reference>
    <citation>Katritsis DG, Giazitzoglou E, Zografos T, Pokushalov E, Po SS, Camm AJ. Rapid pulmonary vein isolation combined with autonomic ganglia modification: a randomized study. Heart Rhythm. 2011 May;8(5):672-8. doi: 10.1016/j.hrthm.2010.12.047. Epub 2010 Dec 31.</citation>
    <PMID>21199686</PMID>
  </reference>
  <reference>
    <citation>Edgerton JR, Brinkman WT, Weaver T, Prince SL, Culica D, Herbert MA, Mack MJ. Pulmonary vein isolation and autonomic denervation for the management of paroxysmal atrial fibrillation by a minimally invasive surgical approach. J Thorac Cardiovasc Surg. 2010 Oct;140(4):823-8. doi: 10.1016/j.jtcvs.2009.11.065. Epub 2010 Mar 17.</citation>
    <PMID>20299028</PMID>
  </reference>
  <reference>
    <citation>Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.</citation>
    <PMID>20227287</PMID>
  </reference>
  <reference>
    <citation>Pokushalov E, Romanov A, Shugayev P, Artyomenko S, Shirokova N, Turov A, Katritsis DG. Selective ganglionated plexi ablation for paroxysmal atrial fibrillation. Heart Rhythm. 2009 Sep;6(9):1257-64. doi: 10.1016/j.hrthm.2009.05.018. Epub 2009 May 20.</citation>
    <PMID>19656736</PMID>
  </reference>
  <reference>
    <citation>Gelsomino S, Lozekoot P, La Meir M, Lorusso R, Luca F, Rostagno C, Renzulli A, Parise O, Matteucci F, Gensini GF, Crjins HJ, Maessen JG. Is ganglionated plexi ablation during Maze IV procedure beneficial for postoperative long-term stable sinus rhythm? Int J Cardiol. 2015 Aug 1;192:40-8. doi: 10.1016/j.ijcard.2015.04.259. Epub 2015 May 1.</citation>
    <PMID>25985014</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <last_update_submitted>July 31, 2017</last_update_submitted>
  <last_update_submitted_qc>July 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Left Atrial Cryoablation</keyword>
  <keyword>Ganglionated Plexi</keyword>
  <keyword>Open-Heart Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Aortic Valve Disease</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/NCT03239262
org study id: FNO-Cardiosurgery-1
nct id: NCT03239262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of our study was to investigate, whether enhancement of left atrial cryoablation by
      ablation of the autonomic nervous system of left atrium leads to influencing the outcomes of
      surgical treatment of atrial fibrillation in patients with structural heart disease
      undergoing open-heart surgery.
The observed patient file consisted of 100 patients, who have undergone a combined open-heart
      surgery at our department between July 2012 and December 2014. The patients were indicated
      for the surgical procedure due to structural heart disease, and suffered from paroxysmal,
      persistent, or long-standing persistent atrial fibrillation. In all cases, left atrial
      cryoablation was performed in the extent of isolation of pulmonary veins, box lesion,
      connecting lesion with mitral annulus, amputation of the left atrial appendage and connecting
      lesion of the appendage base with left pulmonary veins. Furthermore, thirty-five of the
      patients underwent mapping and radiofrequency ablation of ganglionated plexi, together with
      decision and ablation of the ligament of Marshall.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two groups of patients undergoing standard treatment have been compared retrospectively.
primary purpose: Treatment
masking: None (Open Label)
measure: Sinus Rhythm
time frame: 30 months
description: The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.
measure: Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery
time frame: 30 months
description: The secondary outcome was the detection of relationship between the recurrence of atrial fibrillation and the presence of a mitral valve surgery, the presence of a mitral and tricuspid valves surgery and the left atrium diameter >50 mm.
arm group label: Group GP
arm group type: Experimental
description: Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).
arm group label: Group LA
arm group type: Experimental
description: Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).
intervention type: Procedure
intervention name: Concomitant Mapping and Radiofrequency Ablation
description: Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall.
GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared.
arm group label: Group GP
intervention type: Procedure
intervention name: No intervention
description: No intervention was performed in patients without ganglionated plexi.
arm group label: Group LA
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jiri Barta, MD
role: Principal Investigator
affiliation: University Hospital Ostrava
last name: Radim Brat, MD,PhD,MBA
role: Study Chair
affiliation: University Hospital Ostrava
citation: Hou Y, Scherlag BJ, Lin J, Zhang Y, Lu Z, Truong K, Patterson E, Lazzara R, Jackman WM, Po SS. Ganglionated plexi modulate extrinsic cardiac autonomic nerve input: effects on sinus rate, atrioventricular conduction, refractoriness, and inducibility of atrial fibrillation. J Am Coll Cardiol. 2007 Jul 3;50(1):61-8. doi: 10.1016/j.jacc.2007.02.066. Epub 2007 Jun 18.
PMID: 17601547
citation: Katritsis DG, Giazitzoglou E, Zografos T, Pokushalov E, Po SS, Camm AJ. Rapid pulmonary vein isolation combined with autonomic ganglia modification: a randomized study. Heart Rhythm. 2011 May;8(5):672-8. doi: 10.1016/j.hrthm.2010.12.047. Epub 2010 Dec 31.
PMID: 21199686
citation: Edgerton JR, Brinkman WT, Weaver T, Prince SL, Culica D, Herbert MA, Mack MJ. Pulmonary vein isolation and autonomic denervation for the management of paroxysmal atrial fibrillation by a minimally invasive surgical approach. J Thorac Cardiovasc Surg. 2010 Oct;140(4):823-8. doi: 10.1016/j.jtcvs.2009.11.065. Epub 2010 Mar 17.
PMID: 20299028
citation: Yilmaz A, Geuzebroek GS, Van Putte BP, Boersma LV, Sonker U, De Bakker JM, Van Boven WJ. Completely thoracoscopic pulmonary vein isolation with ganglionic plexus ablation and left atrial appendage amputation for treatment of atrial fibrillation. Eur J Cardiothorac Surg. 2010 Sep;38(3):356-60. doi: 10.1016/j.ejcts.2010.01.058. Epub 2010 Mar 12.
PMID: 20227287
citation: Pokushalov E, Romanov A, Shugayev P, Artyomenko S, Shirokova N, Turov A, Katritsis DG. Selective ganglionated plexi ablation for paroxysmal atrial fibrillation. Heart Rhythm. 2009 Sep;6(9):1257-64. doi: 10.1016/j.hrthm.2009.05.018. Epub 2009 May 20.
PMID: 19656736
citation: Gelsomino S, Lozekoot P, La Meir M, Lorusso R, Luca F, Rostagno C, Renzulli A, Parise O, Matteucci F, Gensini GF, Crjins HJ, Maessen JG. Is ganglionated plexi ablation during Maze IV procedure beneficial for postoperative long-term stable sinus rhythm? Int J Cardiol. 2015 Aug 1;192:40-8. doi: 10.1016/j.ijcard.2015.04.259. Epub 2015 May 1.
PMID: 25985014
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Coronary Artery Disease
mesh term: Aortic Valve Disease
sharing ipd: No