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

Primary Purpose

Paroxysmal Atrial Fibrillation, Atrial Fibrillation

Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Radiofrequency ablation
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Prapa KanagaratnamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Redo pulmonary vein isolation

Ganglionated plexus ablation + redo pulmonary vein isolation

Arm Description

Outcomes

Primary Outcome Measures

Any atrial arrhythmia >30s documented on ECGs
After blanking period 3 months

Secondary Outcome Measures

Symptom recurrence requiring repeat ablations
Complications
Radiofrequency time

Full Information

First Posted
May 14, 2018
Last Updated
September 22, 2022
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03535818
Brief Title
Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
October 3, 2023 (Anticipated)
Study Completion Date
October 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomised, controlled, prospective study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Redo pulmonary vein isolation
Arm Type
Active Comparator
Arm Title
Ganglionated plexus ablation + redo pulmonary vein isolation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation
Intervention Description
RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation
Primary Outcome Measure Information:
Title
Any atrial arrhythmia >30s documented on ECGs
Description
After blanking period 3 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Symptom recurrence requiring repeat ablations
Time Frame
12 months
Title
Complications
Time Frame
12 months
Title
Radiofrequency time
Time Frame
Within ablation procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Nicholson
Phone
020759 41862
Email
r.nicholson@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prapa Kanagaratnam
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, PhD
Phone
02078863783
Email
p.kanagaratnam@imperial.ac.uk
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

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