Ablation of nerve endings in the right atrium for treating atrial fibrillation
Understanding the Role of Right Atrial Ectopy-triggering Ganglionated Plexuses in Atrial Fibrillation
This study is testing a new procedure that targets nerve endings in the right side of the heart to help people with persistent atrial fibrillation who haven't found relief from standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT05539040 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ablating nerve endings in the right atrium to treat patients with atrial fibrillation (AF) who have not responded to standard left atrial ablation. The research team has previously shown that targeting ganglionated plexuses in the left atrium can reduce AF symptoms with less heart injury. Participants will be recruited from those on the waiting list for AF ablation and will undergo a procedure to assess the impact of right atrial ganglionated plexus ablation. The study aims to provide a new treatment option for patients suffering from persistent AF.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with symptomatic paroxysmal atrial fibrillation who are suitable for catheter ablation.
Not a fit: Patients with contraindications to catheter ablation, severe comorbidities, or those with a life expectancy shorter than the trial duration may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new treatment avenue for patients with atrial fibrillation who have not benefited from standard therapies.
How similar studies have performed: Previous studies have shown promise in ablating ganglionated plexuses in the left atrium, but this approach in the right atrium is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- Hammersmith Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Prapa Kanagaratnam, MBBChir, PhD — Imperial College London
- Study coordinator: Jamie Kay, MBBS BMedSci
- Email: jamie.kay@imperial.ac.uk
- Phone: 02033131000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.