Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation
ADD-GP
Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus
1 other identifier
interventional
68
1 country
1
Brief Summary
The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 14, 2017
CompletedFirst Submitted
Initial submission to the registry
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2026
CompletedAugust 9, 2024
August 1, 2024
8.6 years
May 14, 2018
August 6, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Any atrial arrhythmia >30s documented on ECGs
After blanking period 3 months
12 months
Secondary Outcomes (3)
Symptom recurrence requiring repeat ablations
12 months
Complications
12 months
Radiofrequency time
Within ablation procedure
Study Arms (2)
Redo pulmonary vein isolation
ACTIVE COMPARATORGanglionated plexus ablation + redo pulmonary vein isolation
ACTIVE COMPARATORInterventions
RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prapa Kanagaratnam
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prapa Kanagaratnam, PhD
Imperial College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2018
First Posted
May 24, 2018
Study Start
June 14, 2017
Primary Completion
February 1, 2026
Study Completion
February 1, 2026
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share