NCT02487654

Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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: 1. Pulmonary vein isolation alone 2. 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.

Conditions

• Paroxysmal Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Pulmonary vein isolation	Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
PROCEDURE	Ganglionated plexus ablation	Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Timeline

• Start date: 2017-12-01
• Primary completion: 2023-10-23
• Completion: 2024-10-23
• First posted: 2015-07-01
• Last updated: 2024-09-23
• Results posted: 2024-09-23

Locations

3 sites across 1 country: United Kingdom