The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF
Understanding the Role of Right Atrial Ectopy-triggering Ganglionated Plexuses in Atrial Fibrillation
Imperial College London
116 participants
Feb 21, 2023
INTERVENTIONAL
Conditions
Summary
Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes. The best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people. The study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs). The study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again
Eligibility
Inclusion Criteria4
- Males or females from 18 to 85yrs old
- Symptomatic paroxysmal atrial fibrillation
- Suitable candidate for catheter ablation
- Signed informed consent
Exclusion Criteria17
- Contraindication to catheter ablation
- Contraindication for general anaesthetic
- Presence of a left ventricular thrombus
- Valvular disease that is grade moderate or greater
- Any form of cardiomyopathy
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
- Serum Creatinine \>200umol/L/ on dialysis/ at risk of dialysis
- Active infection or fever
- Life expectancy shorter than the duration of the trial
- Allergy to contrast
- Moderate to severe heart failure and/or NYHA Class III-IV
- Bleeding or clotting disorders or inability to receive heparin
- 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
- Unable to give informed consent
Interventions
A 3D electroanatomic map of the right atrium will be made. During sinus rhythm, the ablation catheter will be positioned at a spot to test with HFS. The right atrium will be paced at a fixed rate, for up to four beats to ensure that there is no ventricular capture then a short burst of HFS will be synchronized to each paced stimulus for up to 15 trains. This will be performed using a custom-built GP stimulator that has been validated for reproducibility against Grass Stimulator (AstroMed). All Sites will be marked on the 3D map and the positive sites will be ablated at the end of the mapping. If the patient converts to AF, then DC cardioversion will be performed. If mapping in sinus rhythm is not feasible, HFS will be performed continuously for several seconds to identify atrioventricular dissociating GPs (AVD-GPs). Every ablated GP site will be re-tested with HFS at the end of the procedure until they are all rendered non-functional.
48 hour Holter monitors will be performed post procedure to monitor for recurrence of AF. These will be performed at 3, 6, 9, 12 months
Transseptal puncture for access into the left atrium will be guided by TOE and fluoroscopy. ACT will be maintained at 300s with heparin. A 3D electroanatomic map of the left atrium will be created and all PVs will be identified. Touch-up radiofrequency ablation will be performed at electrical gaps around the reconnected PVs until complete PVI is achieved.
CONTROL ARM (Redo-PVI) only: If all Pulmonary veins are isolated at the start of the procedure, the operator will be allowed to perform a right cavo-tricuspid and left roof linear ablation.
All patients will be provided with an AliveCor KardiaMobile-6L ECG recorder. The device will continue to be used within its CE-marked and NICE-approved purpose. Patients will be asked to take a daily recording from this, once the blanking period is over, in addition to taking a recording if symptomatic. Patients will submit this to the connected care team at Hammersmith Hospital via a secure NHS.net email address, who will assess the recordings both for the study and clinical purposes.
A Quality of life questionnaire will be performed at baseline, 6 and 12 months to assess the effect of the procedures on patients quality of life.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05539040