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

September 16, 2024 updated by: Imperial College London

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom
        • St Bartholomew's Hospital
      • Plymouth, United Kingdom
        • Derriford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure
Time Frame: 3 to 12 months post-ablation.
That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence .
3 to 12 months post-ablation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation
Time Frame: 3 to 12 months post-ablation.
The reduction was defined as either a decrease of dose or a cessation of a drug over a 12 month follow-up period post ablation.
3 to 12 months post-ablation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Prapa Kanagaratnam, PhD, Imperial College NHS Healthcare Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

October 23, 2023

Study Completion (Estimated)

October 23, 2024

Study Registration Dates

First Submitted

November 25, 2013

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimated)

July 1, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13SM0713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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