Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

NCT ID: NCT02487654

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2024-10-23

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:

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pulmonary vein isolation

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation

Intervention Type: PROCEDURE

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Ganglionated plexus ablation

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Group Type: EXPERIMENTAL

Ganglionated plexus ablation

Intervention Type: PROCEDURE

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Interventions

Pulmonary vein isolation

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Intervention Type: PROCEDURE

Ganglionated plexus ablation

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Intervention Type: PROCEDURE

Other Intervention Names

PVI; GP ablation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prapa Kanagaratnam, PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College NHS Healthcare Trust

Locations

Hammersmith Hospital

London, , United Kingdom

St Bartholomew's Hospital

London, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34915187 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13SM0713

Identifier Type: -

Identifier Source: org_study_id