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Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

Primary Purpose

Mitral Valve Disease, Coronary Artery Disease, Tricuspid Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Concomitant Mapping and Radiofrequency Ablation
No intervention
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Disease focused on measuring Atrial Fibrillation, Left Atrial Cryoablation, Ganglionated Plexi, Open-Heart Surgery

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other)
  • Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation
  • Signing of the informed consent

Exclusion Criteria:

  • Age below 40 and over 80 years of age
  • Left ventricular ejection fraction below 25%
  • Left atrium diameter over 60mm
  • Permanent atrial fibrillation
  • Polymorbidity (Euroscore II over 10)
  • Emergency surgery
  • Renal insufficiency (creatinine over 200 umol/l)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group GP

    Group LA

    Arm Description

    Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).

    Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).

    Outcomes

    Primary Outcome Measures

    Sinus Rhythm
    The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.

    Secondary Outcome Measures

    Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery
    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.

    Full Information

    First Posted
    July 26, 2017
    Last Updated
    July 31, 2017
    Sponsor
    University Hospital Ostrava
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03239262
    Brief Title
    Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2012 (Actual)
    Primary Completion Date
    January 31, 2016 (Actual)
    Study Completion Date
    February 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital Ostrava

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mitral Valve Disease, Coronary Artery Disease, Tricuspid Valve Disease, Aortic Valve Disease, Atrial Fibrillation
    Keywords
    Atrial Fibrillation, Left Atrial Cryoablation, Ganglionated Plexi, Open-Heart Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups of patients undergoing standard treatment have been compared retrospectively.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group GP
    Arm Type
    Experimental
    Arm Description
    Thirty-five patients (35%) from our population underwent concomitant mapping and radiofrequency ablation of ganglionated plexi (Group GP).
    Arm Title
    Group LA
    Arm Type
    Experimental
    Arm Description
    Sixty five patients (65%) in whom no intervention related to ganglionated plexi was performed (Group LA).
    Intervention Type
    Procedure
    Intervention Name(s)
    Concomitant Mapping and Radiofrequency Ablation
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    No intervention
    Intervention Description
    No intervention was performed in patients without ganglionated plexi.
    Primary Outcome Measure Information:
    Title
    Sinus Rhythm
    Description
    The primary outcome was establishment and duration of sinus rhythm in the course of one-year follow-up.
    Time Frame
    30 months
    Secondary Outcome Measure Information:
    Title
    Recurrence of Atrial Fibrillation and the Presence of a Mitral Valve Surgery
    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.
    Time Frame
    30 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Indication for open-heart surgery (mitral valve disease and/or tricuspidal valve disease and/or aortic valve disease and/or coronary artery disease and/or other) Concomitant paroxysmal, persistent, long standing persistent atrial fibrillation Signing of the informed consent Exclusion Criteria: Age below 40 and over 80 years of age Left ventricular ejection fraction below 25% Left atrium diameter over 60mm Permanent atrial fibrillation Polymorbidity (Euroscore II over 10) Emergency surgery Renal insufficiency (creatinine over 200 umol/l)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jiri Barta, MD
    Organizational Affiliation
    University Hospital Ostrava
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Radim Brat, MD,PhD,MBA
    Organizational Affiliation
    University Hospital Ostrava
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    17601547
    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.
    Results Reference
    background
    PubMed Identifier
    21199686
    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.
    Results Reference
    background
    PubMed Identifier
    20299028
    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.
    Results Reference
    background
    PubMed Identifier
    20227287
    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.
    Results Reference
    background
    PubMed Identifier
    19656736
    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.
    Results Reference
    background
    PubMed Identifier
    25985014
    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.
    Results Reference
    background

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    Left Atrial Cryoablation Enhanced by Ganglionated Plexi Ablation in the Treatment of Atrial Fibrillation

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