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
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
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
NCT ID
NCT03239262
First Posted
July 26, 2017
Last Updated
July 31, 2017
Sponsor
University Hospital Ostrava
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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