The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF
Recruiting · NCT05539040 · Interventional (participants receive a specific treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- Males or females from 18 to 85yrs old
- Symptomatic paroxysmal atrial fibrillation
- Suitable candidate for catheter ablation
- Signed informed consent
Exclusion criteria
- 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
Where it is running
1 location listed.
- Hammersmith Hospital - London, United Kingdom