RecruitingNAINTERVENTIONAL

The Role of Right Atrial Ectopy Triggering Ganglionated Plexuses in AF

Atrial fibrillation (AF) is a common heart condition causing an irregular and often fast heartbeat. Current treatments often involve a procedure called 'pulmonary vein isolation' to correct the heart's rhythm, which works for about 60% of people. This study is for individuals whose AF has come back after this standard procedure. Researchers have found that certain nerve endings in the heart, called ganglionated plexuses (GPs), can also trigger AF. They want to see if targeting these GPs in the right side of the heart can prevent AF from recurring. The study will compare this new approach with repeating the standard pulmonary vein isolation procedure in people who are already scheduled for another treatment for their AF.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

116

Start

21 Feb 2023

Estimated completion

02 Dec 2027

Cardiac Arrhythmia Atrial Fibrillation

What is this study about?

Atrial fibrillation (AF) is the most common problem with heart rhythm, causing your heart to beat irregularly or too quickly. This can lead to symptoms like feeling your heart race (palpitations), breathlessness, tiredness, and even fainting spells. It also increases the risk of stroke. Currently, a common treatment for AF involves a procedure called an 'ablation', where doctors carefully burn or freeze small areas inside the heart to correct the rhythm. Often, this is done in the left side of the heart, focusing on areas around the 'pulmonary veins'. This procedure helps about 60% of people.

Our research team has discovered that tiny nerve endings in the heart, known as 'ganglionated plexuses' (GPs), can also play a role in triggering AF. We've previously shown that treating these nerve endings can help prevent AF. Now, we want to investigate this further. This study is designed for people who have already had the standard pulmonary vein ablation, but their AF has returned. We want to see if targeting these specific nerve endings, particularly those found in the right side of the heart, can stop AF from coming back.

In this study, we will compare this new approach of treating the nerve endings (GPs) with simply repeating the standard pulmonary vein isolation procedure. We hope that by targeting these nerve endings, we can offer a more effective solution for people whose AF has persisted or returned after initial treatment. It's important to understand that this is a research study, and we are aiming to improve our understanding and treatment options for AF.

Key takeaways

Targets AF recurrence after previous ablation.
Investigates nerve endings (GPs) as AF triggers.
Compares new approach with standard retreatment.
Participation involves random assignment to treatment groups.
Aims to improve long-term AF outcomes.
Your standard medical care is unaffected by participation.

Who may be eligible?

To be considered for this study, you need to be between 18 and 85 years old and experiencing AF symptoms. You must also be a suitable candidate for the type of ablation procedure being studied and be able to provide your consent to take part.

There are certain reasons why you might not be able to join the study. For example, if you have other serious heart conditions, a blood clot in your heart, severe kidney problems, or certain bleeding disorders. Also, if you have an active infection, certain types of cancer, or are pregnant (or could become pregnant and are not using effective contraception), you wouldn't be able to participate. We would also need to ensure you can safely have a general anaesthetic and don't have any allergies to the materials used in the procedure.

Our team will carefully check all these requirements to make sure the study is safe and appropriate for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 85 years old?
Do you have symptoms of AF?
Are you able to have an ablation procedure?
Have you been told you need another ablation for AF?
Are you able to provide your consent to take part?
Are you NOT pregnant and using effective contraception if you could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will first have a discussion with the research team to understand all aspects of the study. Your information will be anonymised with a unique number and kept confidential. You will continue with your standard NHS care leading up to the procedure.

In the study, you'll be randomly assigned to one of two treatment groups. Both groups will receive an ablation procedure. One group will have the standard repeated pulmonary vein isolation, and the other group will have the same standard procedure along with an additional ablation targeting specific nerve endings in the right side of the heart. All patients will have the steps of the ablation done in the same way, as advised by their doctor. The total duration of your participation in terms of follow-up will be discussed with you by the research team.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more effective treatment for your AF if the new approach proves successful in preventing AF from returning. As with any medical procedure, there are potential risks associated with the ablation, which the medical team will explain in detail. You will receive the standard of care that you would normally receive as part of your NHS treatment. We want to assure you that deciding to take part is entirely voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Atrial Fibrillation (AF)?

AF is a common condition where your heart beats irregularly and often very quickly, which can cause symptoms like palpitations, breathlessness, and tiredness.

What is an ablation procedure?

An ablation is a medical procedure where doctors use heat or cold to create tiny scars inside your heart to block irregular electrical signals and restore a normal heart rhythm.

What are 'ganglionated plexuses' (GPs)?

These are small clusters of nerve endings in the heart that our research suggests can play a role in triggering AF.

Will I know which treatment I receive?

You will be randomly assigned to one of two treatment groups, meaning it will be decided by chance which approach you receive. You will be told which treatment you received after the procedure.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, and this will not affect your ongoing medical care.

How to find out more

Jamie Kay, MBBS BMedSci

jamie.kay@imperial.ac.uk 02033131000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.