NCT05539040Recruiting
The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF
Understanding the Role of Right Atrial Ectopy-triggering Ganglionated Plexuses in Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 28 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 116 (estimated)
- First submitted
- 12 Sept 2022
- Start date
- 21 Feb 2023
- Primary completion date
- 21 Feb 2026
- Lead sponsor
- Imperial College London
- Diseases
- Atrial fibrillation
- NCT number
- NCT05539040
What you commit to
- Study type: Interventional
- Planned participants: 116
- From 21 Feb 2023 to the primary completion date, 21 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Valvular disease that is grade moderate or greater
- Severe cerebrovascular disease
- Active gastrointestinal bleeding
- Active infection or fever
- Allergy to contrast
- Moderate to severe heart failure and/or NYHA Class III-IV
- Bleeding or clotting disorders or inability to receive heparin
- Malignancy needing therapy
Lab values
- Serum Creatinine \>200umol/L/ on dialysis/ at risk of dialysis
- Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
Other
- Contraindication to catheter ablation
- Contraindication for general anaesthetic
- Presence of a left ventricular thrombus
- Any form of cardiomyopathy
- Life expectancy shorter than the duration of the trial
- Pregnancy or women of childbearing potential not using a highly effective method of contraception
- Unable to give informed consent
Who the study is looking for
- Males or females from 18 to 85yrs old
- Symptomatic paroxysmal atrial fibrillation
- Suitable candidate for catheter ablation
- Signed informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.