NCT05539040 The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF
| NCT ID | NCT05539040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Cardiac Arrhythmia |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2023-02-21 |
| Primary Completion | 2026-02-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2023-02-21 with a primary completion date of 2026-02-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Prapa Kanagaratnam, MBBChir, PhD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT05539040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Cardiac Arrhythmia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05539040 currently recruiting?
Yes, NCT05539040 is actively recruiting participants. Contact the research team at jamie.kay@imperial.ac.uk for enrollment information.
Where is the NCT05539040 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05539040 clinical trial?
NCT05539040 is sponsored by Imperial College London. The principal investigator is Prapa Kanagaratnam, MBBChir, PhD at Imperial College London. The trial plans to enroll 116 participants.