Patient-tailored ablation of persistent atrial fibrillation (psGP)
| ISRCTN | ISRCTN11762670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11762670 |
| IRAS number | 265850 |
| Secondary identifying numbers | CPMS 44984, IRAS 265850 |
- Submission date
- 19/02/2021
- Registration date
- 09/02/2022
- Last edited
- 09/02/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The heart rhythm problem called Atrial Fibrillation (AF) is caused by abnormal electrical currents in the small chambers of the heart termed the atria.
Landmark studies have shown that in about half of people with AF, these abnormal electrical currents originate from the pulmonary veins, which join the left atrium to the lungs. A procedure called 'pulmonary vein isolation' (PVI) is done using catheters inside the heart that are introduced through the blood vessels in the groin. Once inside the left atrium, the catheters are used to make small burns along the base of the pulmonary veins where they join the heart to prevent the abnormal electrical currents from reaching the rest of the atria. This prevents AF in about 50% of people.
However, the PVI procedure that we perform is not tailored to each individual patient and we don't know exactly why it works.
A different approach is to target the nerve cells in the atria called ganglionated plexi (GPs). It is thought that these GPs trigger AF and so ablating the GP could be more effective than PVI. They are often found at the base of the pulmonary veins, and also within the atria. Our group has developed a method for locating these GPs and have shown that ablating GP sites can prevent AF. This work has been done mainly in patients who are in normal rhythm most of the time (paroxysmal AF). We now want to see if the same benefit is found in people who are in AF all of the time (so called persistent AF).
Who can participate?
Adults over 18 years, with AF and due to undergo an AF ablation procedure.
What does the study involve?
For the patient, the experience of and recovery from the GP ablation will be the same as the conventional procedure. Patients will be followed up for 1 year with heart rhythm monitors every 3 months to check for recurrence of AF.
What are the possible benefits and risks of participating?
Participating in this research will increase our understanding of the location & function of the nerve cells (GP) in the heart, and help us to understand their role in triggering and maintaining AF. Our research looking at patients with paroxysmal AF suggests that ablating the GPs is at least as good as the standard
PVI procedure, and with less tissue injury. We hope to confirm these preliminary findings and assess whether there may be improved outcomes compared to PVI. Participants will also receive the benefit of increased monitoring during follow up through additional access to the research staff which enables review of any home ECG monitoring they may have and follow up of symptoms.
The risks of this research study are incurred during the catheter ablation procedure. The risks of a catheter ablation procedure are not affected by the GP mapping. The mapping protocol may increase the length of time that the overall procedure takes, by up to an hour, but this is still within a normal range for the time taken to complete an ablation procedure as the duration varies from patient to patient. A procedure using conventional mapping and a procedure undertaken as part of the research protocol are expected to have an identical risk profile as the same equipment and ablation techniques will be used, but the location of the ablation will vary.
Where is the study run from?
The research will be undertaken by Dr Clare Coyle as a part of her PhD thesis. She will be guided by Professor Prapa Kanagaratnam from the National Heart and Lung Institute with input from Dr Nicholas Linton from the Department of Bioengineering at Imperial College London. The procedures will take place at Imperial College Healthcare NHS Trust (UK).
When is the study starting and how long is it expected to run for?
January 2020 to September 2023
Who is funding the study?
British Heart Foundation (UK)
Who is the main contact?
Dr Clare Coyle, c.coyle@imperial.ac.uk
Contact information
Scientific
NHLI ICTEM
72 Du Cane Road
London
W12 0NN
United Kingdom
| Phone | +44 20 7594 2739 |
|---|---|
| c.coyle@imperial.ac.uk |
Study information
| Study design | Interventional non-randomized |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 39496 PIS v1 11Jun2019.pdf |
| Scientific title | Feasibility of identifying autonomic drivers for human Atrial Fibrillation |
| Study objectives | Does patient-tailored ablation of the atrial autonomic nervous system result in reduced recurrence of AF in patients with persistent AF compared to standard ablation targets? |
| Ethics approval(s) | Approved 21/04/2020, South Central Berkshire Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 207 104 8121; berkshire.rec@hra.nhs.uk), ref: 20/SC/0081 |
| Health condition(s) or problem(s) studied | Atrial Fibrillation |
| Intervention | All participants will receive a medication (Amiodarone) for at least 6 weeks prior to their procedure. Study participants will provide informed consent prior to commencement of the study protocol. The preparation for the procedure will be the same as for routine PVI with the patient receiving a general anaesthetic, trans-oesophageal echo (TOE) to assess for left atrial appendage thrombus and the left atrium accessed under TOE guidance as per usual clinic procedure. To start, the patient needs to be in a normal heart rhythm. This may already have been achieved with the Amiodarone but if not they will have a cardioversion ( a small electrical current to revert the heart temporarily to a normal rhythm). High frequency stimulation will be used to identify sites of nerve cells (ganglionated plexi) that can trigger ectopic beats and a map of these sites created. Once this is complete, these areas will be ablated. We will then re-test the sites to ensure there is no evidence of the nerve cells remaining. If the patient goes into AF before mapping is complete, then the sites already mapped will be ablated to trigger a return to sinus rhythm. If this doesn't work then the patient will have up to three cardioversions. If the patient is still in AF, we will map nerve cells that affect the heart rate which we know can be associated with ectopy triggering nerve cells. All patients will be followed up with heart monitors (24 hour Holters) at 3, 6, 9 and 12 months and at routine clinical appointments to see if the AF returns. We will compare their outcomes to a group with similar characteristics but who have received routine PVI treatment (taken from the routine data collected as part of the Cardiology department's routine auditing). We will use statistical tests to measure whether there is a true difference between the two groups. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Recurrence of >30 seconds of AF or atrial tachycardia at 1 year as measured on 24 hour Holters at 3, 6, 9, & 12 months post procedure (after a 90-day blanking period) |
| Secondary outcome measures | 1. Acute cessation of ectopy and/or AF with ablation during the procedure (noted during the procedure) Measured using patient records at the end of the study: 2. Repeat ablation for AF/AT after a 90-day blanking period 3. Mortality 4. Any significant complications related to the procedure requiring intervention |
| Overall study start date | 01/01/2020 |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 50; UK Sample Size: 50 |
| Key inclusion criteria | 1. Atrial Fibrillation due to undergo an AF ablation procedure 2. Informed consent 3. Willing to attend follow up for Holter monitoring 4. Suitable for AF ablation procedure under general anaesthetic |
| Key exclusion criteria | 1. Left Ventricular Ejection Fraction <35% 2. Left atrial size >4.8cm 3. Failed cardio version with sinus rhythm lasting <1 week 4. Any significant co-morbidity precluding general anaesthetic or a contra-indication to ablation 5. Pregnant women 6. Patients with life expectancy less than follow up period 7. Unwillingness to attend follow up HoltersIf 8. Patients who have undergone previous experimental ablation procedures 9. Patients involved in research that could itself be affected by our intervention protocols |
| Date of first enrolment | 01/08/2020 |
| Date of final enrolment | 01/09/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
South Wharf Road
London
W2 1BL
United Kingdom
Sponsor information
University/education
Joint Research and Compliance Office
Imperial College London and Imperial College Healthcare NHS Trust
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +442075949459 |
|---|---|
| becky.ward@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Anonymised datasets generated during and analysed during the current study will be available upon reasonable request from Dr Clare Coyle, c.coyle@imperial.ac.uk, for up to 10 years following the study end date provided the patient consented to data sharing on recruitment to the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 11/06/2019 | 09/02/2022 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
19/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR)
