Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation (ADD-GP)

Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus

The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Intervention / Treatment: Procedure: Radiofrequency ablation

Detailed Description

Patients with ongoing paroxysmal arrhythmias after pulmonary vein isolation (PVI) for paroxysmal and persistent atrial fibrillation (AF) get incrementally less benefit with redo-PVI. This implies non-pulmonary vein (PV) triggers, which are more challenging to locate. The autonomic nervous system is implicated in the multifactorial pathogenesis of AF but few studies have attempted neural targeting as a therapeutic intervention. We have demonstrated that stimulation of specific left atrial ganglionated plexi (GPs) triggers both AF and atrial ectopy and importantly stimulation of these sites may not induce AV block, the 'conventional' marker used to locate GPs. Having shown that these ectopy-triggering GP (ET-GP) sites are anatomically stable and can be rendered inactive by either ablation at the site or by ablation between the site and the adjacent PV, a single centre study suggests that ET-GP ablation can prevent recurrent AF in some patients.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ruth Nicholson; Phone Number: 020759 41862; Email: r.nicholson@imperial.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Prapa Kanagaratnam
    • Principal Investigator: Prapa Kanagaratnam, PhD
    • Contact: Prapa Kanagaratnam, PhD; Phone Number: 02078863783; Email: p.kanagaratnam@imperial.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males or females eighteen (18) to eighty five (85) years old
• Paroxysmal atrial fibrillation
• Previous pulmonary vein isolation
• 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
• Patients who lack capacity
• Active gastrointestinal bleeding
• Active infection or fever
• Renal failure (Creatinine >200µmol/L)
• Life expectancy shorter than the duration of the trial
• Bleeding or clotting disorders or inability to receive heparin
• Pregnant

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Redo pulmonary vein isolation	Procedure: Radiofrequency ablation; RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation
Active Comparator: Ganglionated plexus ablation + redo pulmonary vein isolation	Procedure: Radiofrequency ablation; RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any atrial arrhythmia >30s documented on ECGs	After blanking period 3 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Symptom recurrence requiring repeat ablations	12 months
Complications	12 months
Radiofrequency time	Within ablation procedure

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Prapa Kanagaratnam, PhD, Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): October 3, 2023
• Study Completion (Anticipated): October 3, 2023

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 17HH3712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No