RecruitingNAINTERVENTIONAL

Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation

This study aims to find a better treatment for people with a long-lasting irregular heartbeat called persistent atrial fibrillation (AF). AF can lead to serious problems like strokes and heart failure. Current treatments, like standard 'catheter ablation', often don't work well enough on their own. This research compares the standard treatment with a new, two-step approach called 'convergent ablation' combined with a 'LARIAT procedure'. This new method uses both external and internal techniques to create more effective scars in the heart, which helps control the irregular rhythm. We are looking at how well this new treatment works, if it's safe, and if it could improve patients' quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Barts & The London NHS Trust

Enrolment target

Start

02 Aug 2024

Estimated completion

01 Oct 2026

Persistent Atrial Fibrillation Atrial Fibrillation, Persistent Atrium; Fibrillation Atrial Arrhythmia

What is this study about?

Atrial fibrillation (AF) is a common heart condition where the upper chambers of your heart beat irregularly and too fast. When it's long-lasting, it's called persistent AF. This condition can make you feel tired, out of breath, and increases your risk of having a stroke. Currently, a common treatment involves a procedure called 'catheter ablation', where doctors use thin tubes (catheters) to create small scars inside your heart to block the abnormal electrical signals. However, for persistent AF, this often isn't enough, and many people need further procedures or medication.

This study is exploring a new approach called 'convergent ablation' combined with something called the 'LARIAT procedure'. Think of it as a two-part treatment. First, a surgeon makes very small cuts on the outside of your heart to create scars that help regulate the rhythm. At the same time, the LARIAT device is used to close off a small pouch in the heart called the left atrial appendage (LAA), which is where most blood clots that cause strokes in AF patients form. The second part of the treatment involves a heart specialist using catheters inside your heart to check the work done by the surgeon and make any extra scars needed to fully correct the heart's rhythm. The idea is that combining these external and internal methods will create more complete and lasting scars, leading to a better outcome.

The main goal of this study is to see if this two-step 'convergent ablation' and LARIAT procedure is more effective and safer than the current standard catheter ablation for people with persistent AF. We want to understand if it can lead to fewer irregular heartbeats, reduce the need for more procedures or strong medications, and ultimately improve your daily life. By comparing these two treatments, we hope to find a better long-term solution for patients struggling with persistent AF.

Key takeaways

This study compares a new two-step treatment to standard care for long-lasting irregular heartbeats (persistent AF).
The new treatment combines external surgery and internal catheter procedures to better control heart rhythm.
The LARIAT procedure involved aims to reduce stroke risk by closing a small heart pouch.
The study assesses if the new treatment is safer and more effective at improving heart rhythm and quality of life.
Participation involves being randomly assigned to one of two treatments and regular follow-up appointments.
You must have persistent AF for over a year and meet specific health criteria to be eligible.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old and have had persistent atrial fibrillation for at least a year. Your doctor will also check the size of your heart's upper left chamber; it can't be larger than 6 cm. Importantly, you must be able to understand the study and willingly agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if your AF is caused by something temporary or can be easily reversed, or if you're already in another research study that involves treatments. You also can't participate if you've already had certain heart or abdominal operations, or if you have specific heart problems like hypertrophic cardiomyopathy (a thickened heart muscle) or significant valve disease.

Additionally, if you don't have the small heart pouch called the left atrial appendage, or if it has already been closed off, you wouldn't be able to join. The study also cannot include people who shouldn't take blood-thinning medication (anticoagulation), as this is an important part of managing AF and this study.

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 80 years old?
Have you had persistent atrial fibrillation for more than a year?
Is your heart's left upper chamber (atrium) less than 6cm in size?
Have you *not* had previous heart or abdominal surgery?
Do you *not* have certain serious heart conditions (like hypertrophic cardiomyopathy or significant valve disease)?
Can you provide written consent to join the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the new convergent ablation with the LARIAT procedure or the standard catheter ablation. This is like flipping a coin to decide which treatment you get. Both procedures involve a hospital stay. You will have several follow-up appointments, including check-ups and heart rhythm monitoring, to see how your heart is doing after the procedure.

Before the procedure, you will have various tests like scans and blood tests to make sure you are suitable for the study. After your treatment, doctors will closely monitor your heart rhythm and overall health over a period of time to track the success of the procedure and any side effects. The exact number of visits and the total length of your participation will be explained in detail by the study team, but generally, studies like this involve follow-ups over several months to a year or more.

Potential risks and benefits

Participating in this study might offer you the chance to receive a new, potentially more effective treatment for your persistent atrial fibrillation. If the new convergent procedure proves successful, it could lead to a more stable heart rhythm, a reduced need for medications, and an overall better quality of life. However, like all medical procedures, both the standard and new treatments carry potential risks, such as bleeding, infection, and rare complications to the heart or surrounding structures. The study team will explain all known risks of each procedure in detail. 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.

St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is atrial fibrillation (AF)?

AF is an irregular and often fast heartbeat, where the top chambers of your heart quiver instead of beating effectively.

What does 'persistent' AF mean?

Persistent AF means your irregular heartbeat lasts for more than seven days or requires medication or a procedure to get it back into a normal rhythm.

What is 'ablation'?

Ablation is a procedure where doctors create tiny scars in your heart tissue to block faulty electrical signals that cause irregular heartbeats.

Will I know which treatment I'm getting?

You will be randomly assigned to one of two treatment groups, so it's decided by chance, like drawing lots. The study team will tell you which treatment you receive.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it will not affect your future medical care.

How to find out more

Syed Ahsan

syedahsan@nhs.net 020 7377 7000 Official trial record

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