Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

NCT02487654 | Active Not Recruiting Results

• 1 other identifier: 13SM0713
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 3

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. 1.Pulmonary vein isolation alone
2. 2.GP ablation alone

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure

  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 Outcomes (1)

• Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation

  3 to 12 months post-ablation.

Study Arms (2)

Pulmonary vein isolation

ACTIVE COMPARATOR

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Procedure: Pulmonary vein isolation

Ganglionated plexus ablation

EXPERIMENTAL

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Procedure: Ganglionated plexus ablation

Interventions

Pulmonary vein isolation PROCEDURE

Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.

Also known as: PVI

Pulmonary vein isolation

Ganglionated plexus ablation PROCEDURE

Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium

Also known as: GP ablation

Ganglionated plexus ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females eighteen (18) to eighty five (85) years old
• Paroxysmal atrial fibrillation
• Suitable candidate for catheter ablation
• Signed informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (3)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34915187 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Prapa Kanagaratnam
• Organization: Imperial College London

p.kanagaratnam@imperial.ac.uk

+44 20 3313 1000

Study Officials

• Prapa Kanagaratnam, PhD

  Imperial College NHS Healthcare Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: July 1, 2015
• Study Start: December 1, 2017
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2024
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2024-09

Locations

GB (3)