Active not recruitingNAINTERVENTIONAL

Adjunctive Ganglionated Plexus Ablation in Redo-Pulmonary Vein Isolation

This study is for people who have atrial fibrillation (AF), a type of irregular heartbeat, that returns even after they've had a procedure called pulmonary vein isolation (PVI). Sometimes, after PVI, AF can still be triggered by other parts of the heart, particularly certain nerve bundles called ganglionated plexi. Researchers are investigating if targeting and disrupting these specific nerve bundles during a second PVI procedure (redo-PVI) can help prevent AF from coming back. The aim is to find a more effective treatment strategy for patients whose AF hasn't been successfully managed by the first PVI, ultimately improving their heart health and quality of life.

At a glance

Status

Active not recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

14 Jun 2017

Estimated completion

01 Feb 2026

Paroxysmal Atrial Fibrillation Atrial Fibrillation

What is this study about?

This research study is about finding better ways to treat a common heart condition called atrial fibrillation (AF). AF causes your heart to beat irregularly, which can make you feel dizzy, tired, or short of breath. One common treatment is a procedure called pulmonary vein isolation (PVI), which helps to block electrical signals that cause AF from inside certain heart chambers.

However, for some people, AF can come back even after having PVI. When this happens, it's often because other parts of the heart, not just the pulmonary veins, are triggering the irregular beats. Scientists are particularly interested in tiny bundles of nerves in the heart, called ganglionated plexi, which they believe can play a role in starting AF. These nerve bundles can be difficult to find and treat.

This study will look at whether treating these specific nerve bundles during a second PVI procedure (sometimes called a 'redo' PVI) can help prevent AF from returning. By carefully targeting and disrupting these nerve bundles, doctors hope to reduce the chances of AF coming back for good. The goal is to improve the success rate of treatment for people who need a second procedure for their AF.

Key takeaways

This study is for people whose atrial fibrillation has returned after a previous treatment.
It aims to make repeat heart procedures more effective by targeting specific heart nerves.
The goal is to find better ways to stop atrial fibrillation from coming back.
Participation involves a medical procedure and follow-up appointments.
You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old and have a type of irregular heartbeat called paroxysmal atrial fibrillation (meaning it comes and goes). You must have already had a procedure called pulmonary vein isolation (PVI) in the past, and your doctor must think you are suitable for another procedure called a catheter ablation.

There are also some reasons why you wouldn't be able to join. For example, if you have certain other serious heart conditions, like significant valve disease or certain types of heart muscle weakness (cardiomyopathy), or if you currently have a blood clot in your heart. You also can't participate if you're pregnant, have very poor kidney function, or have certain bleeding disorders.

Finally, you need to be able to understand what the study involves and agree to take part. If you have an active infection, severe tummy bleeding, or are currently taking a specific heart medication called amiodarone, you also wouldn't be able to join.

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 atrial fibrillation that comes and goes?
Have you had a pulmonary vein isolation (PVI) procedure before?
Are you generally healthy enough for another heart procedure?
Do you *not* have a significant heart valve problem or weak heart muscle?
Are you *not* pregnant and *not* taking amiodarone?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves is not fully provided in the summary. However, based on the description, it is likely that taking part would involve undergoing a repeat catheter ablation procedure. This usually means attending hospital for the procedure itself, which involves a short hospital stay.

During and after the procedure, you would likely have regular follow-up appointments with the study team to monitor your heart rhythm and overall health. These appointments could involve heart scans, ECGs, and discussions about your symptoms. The total duration of your participation would be explained by the study team, but clinical trials often involve monitoring for several months to a year or more.

Potential risks and benefits

Taking part in a study like this could potentially offer a new and more effective treatment for your atrial fibrillation if previous treatments haven't fully worked. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or damage to blood vessels or heart tissue. You would be fully informed about all known risks before deciding to take part. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Prapa Kanagaratnam
Verified postcode
London, United Kingdom

Common questions

What is 'atrial fibrillation'?

Atrial fibrillation is a common condition where your heart beats irregularly and often too quickly, which can make you feel tired or breathless.

What is 'pulmonary vein isolation' (PVI)?

PVI is a procedure that creates tiny scars in your heart to block faulty electrical signals that cause atrial fibrillation.

Why would I need a 'redo' PVI?

Sometimes, atrial fibrillation can come back even after a first PVI procedure, meaning you might need another treatment to help your heart beat normally.

What are 'ganglionated plexi'?

These are small bundles of nerves in your heart that can sometimes trigger irregular heartbeats, and this study is looking at treating them.

Is this a new type of treatment?

The study is investigating a new way of doing an existing procedure (PVI) by adding an extra step to target specific nerves, hoping to make it more effective.