Paroxysmal Atrial FibrillationADD-GPNCT03535818
Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation
A study testing Radiofrequency ablation in people with Paroxysmal Atrial Fibrillation and Atrial Fibrillation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigator propose to test the efficacy of adjunctive ET-GP ablation in patients undergoing redo PVI for paroxysmal AF. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Jun 2017to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus
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.
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation
| Study group | Role | What they receive |
|---|---|---|
| Redo pulmonary vein isolation | Active comparator | Not described Receives: Procedure: Radiofrequency ablation |
| Ganglionated plexus ablation + redo pulmonary vein isolation | Active comparator | Not described Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any atrial arrhythmia >30s documented on ECGs
After blanking period 3 months
Measured: 12 months
Secondary outcomes (3)
Symptom recurrence requiring repeat ablations
Measured: 12 months
Complications
Measured: 12 months
Radiofrequency time
Measured: Within ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start14 Jun 2017
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, controlled, prospective study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prapa Kanagaratnam, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535818
- Sponsor's protocol ID
- 17HH3712
- Acronym
- ADD-GP
- Status last verified
- Aug 2024
- First submitted
- 14 May 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive GP Ablation In Redo-PVI: Paroxysmal Atrial Arrhythmias After Pulmonary Vein Isolation Are Driven By Ectopy-Triggering Left Atrial Ganglionated Plexus
- ClinicalTrials.gov ID
- NCT03535818
- Acronym / sponsor ID
- ADD-GP / 17HH3712
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 24 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomised, controlled, prospective study
| Arm | Type | Receives |
|---|---|---|
| Redo pulmonary vein isolation | Active comparator | Procedure: Radiofrequency ablation |
| Ganglionated plexus ablation + redo pulmonary vein isolation | Active comparator | Procedure: Radiofrequency ablation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Contraindication to catheter ablation
- Presence of a cardiac thrombus
- Valvular disease that is grade moderate or greater
- Any form of cardiomyopathy
- On amiodarone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation | Procedure or surgery | Ganglionated plexus ablation + redo pulmonary vein isolation, Redo pulmonary vein isolation |
Primary outcome
Any atrial arrhythmia >30s documented on ECGs
Time frame: 12 months
After blanking period 3 months
3 secondary outcomes
Symptom recurrence requiring repeat ablations
Time frame: 12 months
Complications
Time frame: 12 months
Radiofrequency time
Time frame: Within ablation procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prapa Kanagaratnam, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation in people with Paroxysmal Atrial Fibrillation and Atrial Fibrillation, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any atrial arrhythmia >30s documented on ECGs (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.