Paroxysmal Atrial FibrillationGANGLIA-AFNCT02487654
Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
A study testing Pulmonary vein isolation and Ganglionated plexus ablation in people with Paroxysmal Atrial Fibrillation, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Pulmonary vein isolation and Ganglionated plexus ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Dec 2017to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females eighteen (18) to eighty five (85) years old
- Paroxysmal atrial fibrillation
- 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
- Severe cerebrovascular disease
Show all 18Show fewer
- Active gastrointestinal bleeding
- Renal failure (on dialysis or at risk of requiring dialysis)
- Active infection or fever
- Life expectancy shorter than the duration of the trial
- Allergy to contrast
- Intractable heart failure (NYHA Class IV)
- Bleeding or clotting disorders or inability to receive heparin
- Serum Creatinine >200umol/L
- Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
- Malignancy needing therapy
- Pregnancy or women of childbearing potential not using a highly effective method of contraception
- Patients in current research or have recently been involved in any research prior to recruitment will not be included in the trial.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Hammersmith Hospital
London, W12 0HS
St Bartholomew's Hospital
London
Derriford Hospital
Plymouth
About this study
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Current ablative strategy in drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are electrically isolated from the body of the left atrium. However, success rate of this procedure remain ~50-70% for a single procedure despite advances in mapping and ablation techniques.
Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to understand the role of ET-GP ablation in the treatment of AF by comparing two different strategies:
- Pulmonary vein isolation alone
- GP ablation alone
Read the detailed description
This is a prospective, multi-centre study recruiting patients with paroxysmal AF indicated for AF ablation.
180 patients will be recruited. Patients are randomised to either GP ablation alone or to PVI. All antiarrhythmics are stopped for at least 48 hours prior to their procedures.
All have general anaesthesia and CARTO system (Biosense Webster, inc.) are used for 3D electroanatomical mapping of the left atrium.
Patients randomised to GP ablation will have high frequency mapping performed within the atrial refractory period to identify ectopy or AF triggering GP (ET-GP) sites in the left atrium. Patients in this group will only have GP ablation and will not have pulmonary veins isolated.
The primary endpoint is any documented atrial arrhythmia 30 seconds or more after a 3 month blanking period. This will be assessed for up to 12 months post-procedure, using 48hr Holter monitors at 3, 6, 9 and 12 month intervals.
Secondary endpoints include mortality, major complications and redo procedures.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Pulmonary vein isolation, Ganglionated plexus ablation
- Keywords
- Paroxysmal atrial fibrillation, Pulmonary vein isolation, Ganglionated plexus, Radiofrequency ablation, Pulmonary vein ectopy, High frequency stimulation, autonomic nervous system, Ganglionated plexi, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary vein isolationProcedure or surgery
Also called PVI
Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
Ganglionated plexus ablationProcedure or surgery
Also called GP ablation
Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. Receives: Procedure: Pulmonary vein isolation |
| Ganglionated plexus ablation | Experimental | Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium Receives: Procedure: Ganglionated plexus ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure
That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence .
Measured: 3 to 12 months post-ablation.
Secondary outcomes (1)
Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation
The reduction was defined as either a decrease of dose or a cessation of a drug over a 12 month follow-up period post ablation.
Measured: 3 to 12 months post-ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start1 Dec 2017
- Primary completion23 Oct 2023
- Study completion23 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 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 NHS Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487654
- Sponsor's protocol ID
- 13SM0713
- Acronym
- GANGLIA-AF
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2013
- Last updated
- 23 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim MY, Coyle C, Tomlinson DR, Sikkel MB, Sohaib A, Luther V, Leong KM, Malcolme-Lawes L, Low B, Sandler B, Lim E, Todd M, Fudge M, Wright IJ, Koa-Wing M, Ng FS, Qureshi NA, Whinnett ZI, Peters NS, Newcomb D, Wood C, Dhillon G, Hunter RJ, Lim PB, Linton NWF, Kanagaratnam P. Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: GANGLIA-AF study. Heart Rhythm. 2022 Apr;19(4):516-524. doi: 10.1016/j.hrthm.2021.12.010. Epub 2021 Dec 13.
PubMed 34915187
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02487654
- Acronym / sponsor ID
- GANGLIA-AF / 13SM0713
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- Paroxysmal atrial fibrillation, Pulmonary vein isolation, Ganglionated plexus, Radiofrequency ablation, Pulmonary vein ectopy, High frequency stimulation, autonomic nervous system, Ganglionated plexi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 23 Oct 2023 (actual)
- Study completion
- 23 Oct 2024 (estimated)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atrial fibrillation (AF) is a common heart rhythm disorder which can significantly affect a patient's quality of life and cause strokes. Abnormal electrical activity from the pulmonary veins are thought to be the most common cause of this condition. Current ablative strategy in drug refractory AF is pulmonary vein isolation (PVI), where the pulmonary veins are electrically isolated from the body of the left atrium. However, success rate of this procedure remain ~50-70% for a single procedure despite advances in mapping and ablation techniques.
Ganglionated plexuses (GP) are dense clusters of nerves in the atria that are implicated in AF. Endocardial high frequency stimulation (HFS) delivered within the local atrial refractory period can trigger ectopy and AF from specific GP sites (ET-GP). The aim of this study was to understand the role of ET-GP ablation in the treatment of AF by comparing two different strategies:
- Pulmonary vein isolation alone
- GP ablation alone
Detailed description
This is a prospective, multi-centre study recruiting patients with paroxysmal AF indicated for AF ablation.
180 patients will be recruited. Patients are randomised to either GP ablation alone or to PVI. All antiarrhythmics are stopped for at least 48 hours prior to their procedures.
All have general anaesthesia and CARTO system (Biosense Webster, inc.) are used for 3D electroanatomical mapping of the left atrium.
Patients randomised to GP ablation will have high frequency mapping performed within the atrial refractory period to identify ectopy or AF triggering GP (ET-GP) sites in the left atrium. Patients in this group will only have GP ablation and will not have pulmonary veins isolated.
The primary endpoint is any documented atrial arrhythmia 30 seconds or more after a 3 month blanking period. This will be assessed for up to 12 months post-procedure, using 48hr Holter monitors at 3, 6, 9 and 12 month intervals.
Secondary endpoints include mortality, major complications and redo procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary vein isolation | Active comparator | Procedure: Pulmonary vein isolationConventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. |
| Ganglionated plexus ablation | Experimental | Procedure: Ganglionated plexus ablationEndocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females eighteen (18) to eighty five (85) years old
- Paroxysmal atrial fibrillation
- Suitable candidate for catheter ablation
- Signed informed consent
Key exclusion criteria (18 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 |
|---|---|---|
| Pulmonary vein isolationAlso: PVIConventional endocardial radiofrequency catheter ablation for pulmonary vein isolation. | Procedure or surgery | Pulmonary vein isolation |
| Ganglionated plexus ablationAlso: GP ablationEndocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium | Procedure or surgery | Ganglionated plexus ablation |
Primary outcome
Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure
Time frame: 3 to 12 months post-ablation.
That is documented recurrent atrial arrhythmia lasting 30 seconds or more after a blanking period of 3 months; the outcome measure will be assessed up to 12 months of follow-up with 48hr halter monitors arranged every 3 months to investigate Arrhythmia recurrence .
1 secondary outcome
Number of Participants Presenting a Reduction in the Usage of Antiarrhythmics Post-ablation
Time frame: 3 to 12 months post-ablation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34915187Kim MY, Coyle C, Tomlinson DR, Sikkel MB, Sohaib A, Luther V, Leong KM, Malcolme-Lawes L, Low B, Sandler B, Lim E, Todd M, Fudge M, Wright IJ, Koa-Wing M, Ng FS, Qureshi NA, Whinnett ZI, Peters NS, Newcomb D, Wood C, Dhillon G, Hunter RJ, Lim PB, Linton NWF, Kanagaratnam P. Ectopy-triggering ganglionated plexuses ablation to prevent atrial fibrillation: GANGLIA-AF study. Heart Rhythm. 2022 Apr;19(4):516-524. doi: 10.1016/j.hrthm.2021.12.010. Epub 2021 Dec 13.
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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 NHS Healthcare Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary vein isolation and Ganglionated plexus ablation in people with Paroxysmal Atrial Fibrillation, run by Imperial College London at 3 sites 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 4 inclusion and 18 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With no Evidence of >30s Recurrent Atrial Arrhythmia Post-index Procedure (time frame: 3 to 12 months post-ablation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487654, which also lists 1 linked publication.
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 23 Sep 2024.