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

Sponsor
Imperial College London (Other)
Overall Status
Recruiting
CT.gov ID
NCT03535818
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
51.6
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Radiofrequency ablation
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomised, controlled, prospective studyRandomised, controlled, prospective study
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus
Actual Study Start Date :
Jun 14, 2017
Anticipated Primary Completion Date :
Oct 3, 2021
Anticipated Study Completion Date :
Oct 3, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Any atrial arrhythmia >30s documented on ECGs [12 months]

    After blanking period 3 months

Secondary Outcome Measures

  1. Symptom recurrence requiring repeat ablations [12 months]

  2. Complications [12 months]

  3. Radiofrequency time [Within ablation procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Imperial College London London United Kingdom W3 8FX

Sponsors and Collaborators

  • Imperial College London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imperial College London
ClinicalTrials.gov Identifier:
NCT03535818
Other Study ID Numbers:
  • 17HH3712
First Posted:
May 24, 2018
Last Update Posted:
Feb 16, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Feb 16, 2021