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Active, not recruitingNCT03535818ADD-GPUpdated Aug 9, 2024

Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

An interventional study of Radiofrequency ablation in Paroxysmal Atrial Fibrillation and Atrial Fibrillation, sponsored by Imperial College London. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
  • Registered 11 months after the study started (first participant enrolled Jun 2017, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Paroxysmal Atrial Fibrillation
  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 68 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
68 participants (actual)

Study arms

  • Active comparator
    Redo pulmonary vein isolation

    Procedure: Radiofrequency ablation

  • Active comparator
    Ganglionated plexus ablation + redo pulmonary vein isolation

    Procedure: Radiofrequency ablation

Interventions

  • ProcedureRadiofrequency ablation

    RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation

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What researchers measure

Primary outcomes

  1. Any atrial arrhythmia >30s documented on ECGs

    After blanking period 3 months

    Time frame: 12 months

Secondary outcomes

  1. Symptom recurrence requiring repeat ablations

    Time frame: 12 months

  2. Complications

    Time frame: 12 months

  3. Radiofrequency time

    Time frame: Within ablation procedure

07

Study locations

1 site
  • Prapa Kanagaratnam
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03535818
Lead sponsor
Imperial College London
Responsible party
Sponsor
First posted
May 24, 2018
Start date
Jun 14, 2017
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 9, 2024

Study contacts

Prapa Kanagaratnam, PhD
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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