RecruitingNAINTERVENTIONAL

Ablation of Focal Activation in Atrial Fibrillation

This study is looking into persistent atrial fibrillation (AF), a common heart rhythm problem. While standard treatment, called pulmonary vein isolation (PVI), helps many, some still experience AF. We are exploring a new mapping technique, called RETRO-Mapping, which can identify specific electrical areas, or 'drivers', that might be keeping AF going. The study wants to find out if treating these particular drivers, alongside the usual PVI treatment, helps to better control AF. We believe that by targeting these specific areas, we might improve the success rate of AF treatment without unnecessary procedures. The overall goal is to understand how persistent AF works and find more effective ways to manage it for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

110

Start

30 Apr 2024

Estimated completion

01 Oct 2026

Atrial Fibrillation Atrial Fibrillation, Persistent Arrhythmia Arrhythmias, Cardiac Cardiac Arrhythmia

What is this study about?

Atrial fibrillation (AF) is a common condition where your heart beats irregularly. When this problem is ongoing, it's called persistent AF. Doctors often treat AF with a procedure called pulmonary vein isolation (PVI), which involves carefully burning or freezing small areas of heart tissue to block faulty electrical signals. While PVI works well for many, some people continue to experience AF, suggesting there might be other underlying causes that we don't fully understand yet.

This study is looking at a new way to understand and treat persistent AF. We suspect that persistent AF might be maintained by specific focal 'drivers' – small areas in the heart that keep sending out abnormal electrical signals. Currently, it's been difficult to pinpoint these drivers, especially in ongoing AF. We're using a new technology called RETRO-Mapping, which is designed to accurately find these specific electrical 'hotspots'. This tool can help us map out the heart's electrical activity in much more detail than before.

Our aim is to see if treating these specific 'driver' areas, alongside the standard PVI treatment, can lead to better outcomes for people with persistent AF. We believe that by focusing on these exact areas, we might improve the treatment's success and help more people achieve a normal heart rhythm. This research is important because it could lead to more personalised and effective treatments for persistent AF in the future.

Key takeaways

Investigating new ways to treat persistent AF.
Uses advanced 'RETRO-Mapping' to find AF 'drivers'.
Compares standard treatment with standard + targeted treatment.
Aims for more effective and personalised AF management.
You participate if you are suitable for a standard ablation procedure.

Who may be eligible?

This study is for adults aged between 18 and 85 who have persistent atrial fibrillation and have been recommended for a procedure called catheter ablation by their doctor. You would need to be well enough for this procedure and the general anaesthetic it involves.

There are certain reasons why you might not be able to join the study. These include if you’ve had previous heart ablation procedures for AF, have certain heart conditions like moderate or severe heart failure, or severe valve disease. We also can't include you if you have active infections, kidney problems, uncontrolled diabetes, or certain bleeding disorders. It's also not suitable if you are pregnant, planning to become pregnant, or have any other medical conditions that would make the procedure unsafe.

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 persistent atrial fibrillation?
Has your doctor recommended catheter ablation for you?
Have you NOT had a previous heart ablation for AF?
Do you NOT have severe heart or kidney problems?
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 take part in this study, you would undergo a catheter ablation procedure, which is a standard treatment for atrial fibrillation. During this procedure, the RETRO-Mapping technology will be used to identify specific electrical 'drivers' in your heart. You would then be randomly assigned to one of two groups: one group will receive the standard pulmonary vein isolation (PVI) treatment only, and the other group will receive PVI plus additional treatment targeting the specific 'driver' areas identified by RETRO-Mapping. The study will monitor your heart rhythm to see how well the treatment has worked. The main focus is on how the treatment affects your heart's electrical cycle, and we'll also be looking at whether you remain free from AF. The total duration of the trial is not specified, but you would have follow-up appointments to check your progress after the procedure.

Potential risks and benefits

Taking part in this study might offer the potential benefit of a more targeted and potentially more effective treatment for your persistent atrial fibrillation, leading to a better chance of maintaining a normal heart rhythm. However, as with any medical procedure, there are potential risks associated with catheter ablation, which your doctor will discuss with you. These can include risks related to the procedure itself, general anaesthetic, and potential complications like bleeding or infection. You have the right to withdraw from the study at any time without affecting your ongoing 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'?

Atrial fibrillation (AF) is a common heart condition where your heart beats irregularly and sometimes very fast. 'Persistent' AF means this irregular heartbeat is ongoing.

What is 'catheter ablation'?

Catheter ablation is a procedure where doctors use thin, flexible wires (catheters) to correct abnormal electrical signals in your heart by carefully burning or freezing small areas of tissue.

What is 'RETRO-Mapping'?

RETRO-Mapping is a new technology that helps doctors create very detailed maps of your heart's electrical activity. It's designed to find specific faulty electrical signals that might be causing your AF.

Will I definitely receive the new treatment?

No, you will be randomly assigned to one of two groups. One group will receive the standard treatment, and the other will receive the standard treatment plus the new, targeted approach using RETRO-Mapping.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time without your medical care being affected.

How to find out more

Prapa Kanagaratnam, FRCP PhD

p.kanagaratnam@imperial.ac.uk ‭020 3312 6666‬ Official trial record

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