Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

Atrial Fibrillation Clinical Trial

— ADD-GP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535818
• Other study ID #: 17HH3712
• Status: Recruiting
• Phase: Phase 2
• Start date: June 14, 2017
• Est. completion date: October 3, 2023

Study information

• Verified date: September 2022
• Source: Imperial College London
• Contact: Ruth Nicholson
• Phone: 020759 41862
• Email: r.nicholson[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 3, 2023
• Est. primary completion date: October 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency ablation
RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation

Locations

Country	Name	City	State
United Kingdom	Prapa Kanagaratnam	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any atrial arrhythmia >30s documented on ECGs	After blanking period 3 months	12 months
Secondary	Symptom recurrence requiring repeat ablations		12 months
Secondary	Complications		12 months
Secondary	Radiofrequency time		Within ablation procedure