Active not recruitingNAINTERVENTIONAL

Ectopy Triggering Ganglionated Plexus Ablation to Prevent Atrial Fibrillation

Atrial fibrillation (AF) is a common heart condition where your heart beats irregularly. This can make you feel unwell and increase your risk of stroke. While current treatments, like isolating certain heart areas (pulmonary vein isolation), help many, they don't work for everyone. This study is exploring a new approach focusing on tiny nerve bundles in the heart called ganglionated plexuses, which are thought to play a role in AF. We want to see if targeting these nerve bundles can more effectively prevent AF. We are comparing two procedures in patients with occasional AF: one where we isolate the problem areas, and another where we specifically treat these nerve bundles to find out which method is better at stopping AF from coming back.

At a glance

Status

Active not recruiting

Phase

Sponsor

Imperial College London

Enrolment target

116

Start

01 Dec 2017

Estimated completion

23 Oct 2024

Paroxysmal Atrial Fibrillation

What is this study about?

Imagine your heart as a finely tuned drum, beating in a steady rhythm. In atrial fibrillation (AF), this rhythm gets out of sync, causing your heart's upper chambers to quiver instead of beat properly. This can make you feel tired, dizzy, or breathless, and over time, it can increase your risk of serious health problems like strokes. Doctors often try to fix this by a procedure called ablation, which creates tiny scars in the heart to block the abnormal electrical signals. One common ablation method is 'pulmonary vein isolation' (PVI), which focuses on the areas around the veins that bring blood to your heart, as these are often where the rogue signals start. However, even with PVI, AF can sometimes return.

This study is looking into another part of the heart's electrical system: tiny clusters of nerves called 'ganglionated plexuses' (GPs). Scientists believe these GPs might also play a role in triggering AF. We're trying to understand if treating these specific nerve clusters through 'ganglionated plexus ablation' could be a more effective way to prevent AF episodes. By comparing this new GP ablation method with the more standard PVI, we hope to find a better long-term solution for people living with occasional AF.

Ultimately, the goal of this research is to improve the lives of people with AF. By understanding which ablation strategy works best, we can help reduce the frequency of AF episodes, lessen the symptoms, and potentially lower the risk of related complications, allowing people to live more comfortably and safely.

Key takeaways

This study compares two different heart ablation procedures for atrial fibrillation (AF).
One treatment focuses on 'pulmonary vein isolation', a common AF procedure.
The other treatment focuses on targeting specific nerve clusters called 'ganglionated plexuses'.
The goal is to find which method better prevents AF from returning.
Participation involves random assignment to one treatment and follow-up for a year.
The study aims to improve treatments and quality of life for people with occasional AF.

Who may be eligible?

To join this study, you need to be between 18 and 85 years old and have been diagnosed with occasional atrial fibrillation (paroxysmal AF). Your doctor will also need to confirm that you are generally suitable for a procedure called catheter ablation.

However, there are certain situations where you wouldn't be able to join. For example, if you have other serious heart problems like severe valve disease or certain existing heart muscle conditions, or if you have a blood clot in your heart. You also can't participate if you have very severe kidney issues, uncontrolled diabetes, active infections, or if you are pregnant or could become pregnant and are not using effective birth control.

Additionally, if you're taking specific medications like amiodarone, have certain bleeding disorders, or have other life-threatening conditions, this study might not be right for you. Your blood test results, like kidney function, also need to be within a certain range.

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?
Have you been diagnosed with occasional atrial fibrillation (paroxysmal AF)?
Are you able to undergo a catheter ablation procedure?
Are you currently pregnant or trying to get pregnant without using effective contraception?
Do you have severe kidney problems or uncontrolled diabetes?
Do you have a severe heart valve problem or a blood clot in your heart?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to one of two treatment groups, like flipping a coin. You might receive either the ganglionated plexus (GP) ablation or the pulmonary vein isolation (PVI) procedure. Both procedures involve a general anaesthetic, meaning you'll be asleep during the process. Before your procedure, you'll need to stop taking any antiarrhythmic medications for at least 48 hours, as instructed by the doctors. The procedure itself involves using special tools to create a detailed map of your heart's electrical activity.

After the procedure, we'll keep a close eye on your heart rhythm to see if the AF comes back. This follow-up will last for up to 12 months. During this time, you'll have several check-ups where you'll wear a small portable heart monitor called a Holter monitor for 48 hours at 3, 6, 9, and 12 months after your procedure. This monitor will record your heart's activity as you go about your daily life. The main aim is to see if any AF episodes lasting 30 seconds or longer occur after the first three months.

Potential risks and benefits

Taking part in this study may offer benefits, such as potentially finding a more effective way to prevent your atrial fibrillation, which could improve your quality of life. However, as with any medical procedure, there are potential risks, including complications from the ablation itself or related to the anaesthetic. These will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Hammersmith Hospital
Verified postcode
London, United Kingdom
St Bartholomew's Hospital
Verified postcode
London, United Kingdom
Derriford Hospital
Verified postcode
Plymouth, United Kingdom

Common questions

What is atrial fibrillation (AF)?

AF is an irregular and often rapid heart rate that can cause symptoms like tiredness or breathlessness, and increases the risk of stroke.

What is an ablation procedure?

Ablation is a procedure that uses heat or cold energy to create tiny scars inside your heart to block faulty electrical signals and restore a normal heartbeat.

What are 'ganglionated plexuses'?

These are small clusters of nerves in the heart that are thought to play a role in triggering atrial fibrillation.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two treatment groups, so you won't know which specific ablation type you'll receive.

How long will the study last for me?

Your participation in the study will involve follow-up appointments for up to 12 months after your procedure.