GANGLIA-AF: Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

Sponsor

Imperial College London (Other)

Overall Status

Completed

CT.gov ID

NCT02487654

Collaborator

(none)

180

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Paroxysmal Atrial Fibrillation	Procedure: Pulmonary vein isolation Procedure: Ganglionated plexus ablation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pulmonary vein isolation Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.	Procedure: Pulmonary vein isolation Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. Other Names: PVI
Experimental: Ganglionated plexus ablation Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium	Procedure: Ganglionated plexus ablation Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Other Names: GP ablation

Arm

Intervention/Treatment

Active Comparator: Pulmonary vein isolation

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Procedure: Pulmonary vein isolation

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Other Names:

PVI

Experimental: Ganglionated plexus ablation

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Procedure: Ganglionated plexus ablation

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Other Names:

GP ablation

Outcome Measures

Primary Outcome Measures

Documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months. [3 to 12 months post-ablation.]
Outcome measure will be assessed up to 12 months of follow-up

Secondary Outcome Measures

Major complications, mortality and redo procedures [3 to 12 months post-ablation.]
Major complications include significant bleed requiring transfusions, pericardiocentesis, stroke.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.