Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation (GANGLIA-AF)
Primary Purpose
Paroxysmal Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary vein isolation
Ganglionated plexus ablation
Sponsored by
About this trial
This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Paroxysmal atrial fibrillation, Pulmonary vein isolation, Ganglionated plexus, Radiofrequency ablation, Pulmonary vein ectopy, High frequency stimulation, autonomic nervous system, Ganglionated plexi, atrial fibrillation
Eligibility Criteria
Inclusion Criteria:
- Males or females eighteen (18) to eighty five (85) years old
- Paroxysmal atrial fibrillation
- Suitable candidate for catheter ablation
- Signed informed consent
Exclusion Criteria:
- Contraindication to catheter ablation
- Presence of a cardiac thrombus
- valvular disease that is grade moderate or greater
- Any form of cardiomyopathy
- On amiodarone therapy
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
- Renal failure (on dialysis or at risk of requiring dialysis)
- Active infection or fever
- Life expectancy shorter than the duration of the trial
- Allergy to contrast
- Intractable heart failure (NYHA Class IV)
- Bleeding or clotting disorders or inability to receive heparin
- Serum Creatinine >200umol/L
- Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
- Malignancy needing therapy
- Pregnancy or women of childbearing potential not using a highly effective method of contraception
- Patients in current research or have recently been involved in any research prior to recruitment will not be included in the trial.
Sites / Locations
- Hammersmith Hospital
- St Bartholomew's Hospital
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Pulmonary vein isolation
Ganglionated plexus ablation
Arm Description
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Outcomes
Primary Outcome Measures
Documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months.
Outcome measure will be assessed up to 12 months of follow-up
Secondary Outcome Measures
Major complications, mortality and redo procedures
Major complications include significant bleed requiring transfusions, pericardiocentesis, stroke.
Full Information
NCT ID
NCT02487654
First Posted
November 25, 2013
Last Updated
February 15, 2021
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02487654
Brief Title
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Acronym
GANGLIA-AF
Official Title
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
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
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Current ablative strategy in drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are electrically isolated from the body of the left atrium. However, success rate of this procedure remain ~50-70% for a single procedure despite advances in mapping and ablation techniques.
Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to understand the role of ET-GP ablation in the treatment of AF by comparing two different strategies:
Pulmonary vein isolation alone
GP ablation alone
Detailed Description
This is a prospective, multi-centre study recruiting patients with paroxysmal AF indicated for AF ablation.
180 patients will be recruited. Patients are randomised to either GP ablation alone or to PVI. All antiarrhythmics are stopped for at least 48 hours prior to their procedures.
All have general anaesthesia and CARTO system (Biosense Webster, inc.) are used for 3D electroanatomical mapping of the left atrium.
Patients randomised to GP ablation will have high frequency mapping performed within the atrial refractory period to identify ectopy or AF triggering GP (ET-GP) sites in the left atrium. Patients in this group will only have GP ablation and will not have pulmonary veins isolated.
The primary endpoint is any documented atrial arrhythmia 30 seconds or more after a 3 month blanking period. This will be assessed for up to 12 months post-procedure, using 48hr Holter monitors at 3, 6, 9 and 12 month intervals.
Secondary endpoints include mortality, major complications and redo procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation
Keywords
Paroxysmal atrial fibrillation, Pulmonary vein isolation, Ganglionated plexus, Radiofrequency ablation, Pulmonary vein ectopy, High frequency stimulation, autonomic nervous system, Ganglionated plexi, atrial fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pulmonary vein isolation
Arm Type
Active Comparator
Arm Description
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Arm Title
Ganglionated plexus ablation
Arm Type
Experimental
Arm Description
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Intervention Type
Procedure
Intervention Name(s)
Pulmonary vein isolation
Other Intervention Name(s)
PVI
Intervention Description
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Intervention Type
Procedure
Intervention Name(s)
Ganglionated plexus ablation
Other Intervention Name(s)
GP ablation
Intervention Description
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
Primary Outcome Measure Information:
Title
Documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months.
Description
Outcome measure will be assessed up to 12 months of follow-up
Time Frame
3 to 12 months post-ablation.
Secondary Outcome Measure Information:
Title
Major complications, mortality and redo procedures
Description
Major complications include significant bleed requiring transfusions, pericardiocentesis, stroke.
Time Frame
3 to 12 months post-ablation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females eighteen (18) to eighty five (85) years old
Paroxysmal atrial fibrillation
Suitable candidate for catheter ablation
Signed informed consent
Exclusion Criteria:
Contraindication to catheter ablation
Presence of a cardiac thrombus
valvular disease that is grade moderate or greater
Any form of cardiomyopathy
On amiodarone therapy
Severe cerebrovascular disease
Active gastrointestinal bleeding
Renal failure (on dialysis or at risk of requiring dialysis)
Active infection or fever
Life expectancy shorter than the duration of the trial
Allergy to contrast
Intractable heart failure (NYHA Class IV)
Bleeding or clotting disorders or inability to receive heparin
Serum Creatinine >200umol/L
Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
Malignancy needing therapy
Pregnancy or women of childbearing potential not using a highly effective method of contraception
Patients in current research or have recently been involved in any research prior to recruitment will not be included in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, PhD
Organizational Affiliation
Imperial College NHS Healthcare Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34915187
Citation
Kim MY, Coyle C, Tomlinson DR, Sikkel MB, Sohaib A, Luther V, Leong KM, Malcolme-Lawes L, Low B, Sandler B, Lim E, Todd M, Fudge M, Wright IJ, Koa-Wing M, Ng FS, Qureshi NA, Whinnett ZI, Peters NS, Newcomb D, Wood C, Dhillon G, Hunter RJ, Lim PB, Linton NWF, Kanagaratnam P. Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: GANGLIA-AF study. Heart Rhythm. 2022 Apr;19(4):516-524. doi: 10.1016/j.hrthm.2021.12.010. Epub 2021 Dec 13.
Results Reference
derived
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Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
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