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OpenTrials
Active, Not Recruiting

NCT Number: NCT03535818

Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prapa Kanagaratnam

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

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

Primary outcomes

  1. Any atrial arrhythmia >30s documented on ECGs

    Time frame: 12 months

    After blanking period 3 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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

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

Acronym: ADD-GP

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
May 24, 2018
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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