RecruitingNAINTERVENTIONAL

Hybrid Ablation of Atrial Fibrillation in Heart Failure

This research study is for people who have a long-lasting irregular heartbeat called atrial fibrillation, especially if they also have heart failure. Atrial fibrillation can make your heart beat too fast or unevenly, and heart failure means your heart isn't pumping blood as well as it should. We're comparing two ways to treat this: a new approach called 'hybrid ablation' and the standard treatment, which is usually 'catheter ablation'. Hybrid ablation involves a team of doctors working together, sometimes using different tools to correct the heart's rhythm. We want to find out if this new combined treatment is more effective at stopping the irregular heartbeats over two years compared to the standard method. This could help improve how we treat people with both these conditions in the future.

At a glance

Status

Recruiting

Phase

Sponsor

St. George's Hospital, London

Enrolment target

120

Start

25 Jun 2022

Estimated completion

01 Oct 2027

Persistent Atrial Fibrillation Atrial Fibrillation, Persistent Atrial Arrhythmia Atrial Fibrillation Heart Failure Left Ventricular (LV) Systolic Dysfunction

What is this study about?

Imagine your heart has an electrical problem, causing it to beat irregularly and sometimes too quickly – this is called atrial fibrillation. When it's long-lasting, we call it persistent atrial fibrillation. Many people with this condition also have heart failure, which means their heart muscle isn't pumping blood as strongly as it should. Both of these problems can make you feel tired, breathless, and generally unwell. Doctors are always looking for better ways to help people manage these conditions and improve their quality of life.

Currently, a common treatment for atrial fibrillation is 'catheter ablation'. This is a procedure where doctors use thin, flexible tubes (catheters) to create tiny scars inside your heart to block the faulty electrical signals causing the irregular beat. This study is looking at a new, combined treatment called 'hybrid ablation'. This approach often involves a team of specialists working together, potentially using different techniques or tools to tackle the problem from both inside and outside the heart.

We want to see if this 'hybrid ablation' is better at keeping your heart in a steady, normal rhythm compared to the standard 'catheter ablation' alone. By comparing these two treatments in a careful way, we hope to learn which one is more effective and safer for people with persistent atrial fibrillation and heart failure. The results could help guide doctors in choosing the best treatment options for patients like you in the future.

Key takeaways

This study compares a new 'hybrid' heart treatment with a standard one.
It's for people with long-lasting irregular heartbeats (atrial fibrillation) and heart failure.
The goal is to find out which treatment keeps a steady heart rhythm best over two years.
Participants will be randomly assigned to one of the two treatment groups.
Regular check-ups will monitor your heart rhythm and health for two years.

Who may be eligible?

To join this study, you need to be aged 18 or older and have been diagnosed with persistent atrial fibrillation (meaning your irregular heartbeat has been ongoing). You also need to have heart failure, specifically where your heart isn't pumping blood effectively (doctors call this an LVEF of less than 50%), and your heart's upper chamber (left atrium) should be somewhat enlarged.

There are some reasons why you might not be able to take part. For example, if you've recently had major heart surgery or a previous 'catheter ablation' for atrial fibrillation. If you're pregnant, breastfeeding, or planning to get pregnant soon, you won't be able to join. Also, if you have certain other serious health issues, recent heart attack or stroke, or can't take blood-thinning medication, this study might not be suitable for you. The doctors will check all these details carefully to make sure the study is safe for you.

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 18 years old or older?
Have you been diagnosed with persistent atrial fibrillation?
Do you also have heart failure with a weakened pumping action?
Have you NOT had 'catheter ablation' for atrial fibrillation before?
Are you NOT pregnant, breastfeeding, or planning to be pregnant within six months?
Have you NOT had a heart attack or stroke in the last 3 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to receive either the standard 'catheter ablation' or the new 'hybrid ablation' treatment. This means it's like a coin toss – you won't get to choose which treatment you receive. Both procedures aim to correct your heart rhythm. After your procedure, there will be a recovery period. Over the next two years, you'll have regular check-ups with the study team. These visits will likely involve checking your heart rhythm, feeling your general health, and making sure the treatment has been successful. The aim is to monitor your heart rhythm very closely for up to 24 months to see how well each treatment works over time. The total duration of your active participation, including follow-up, will be around two years.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach that isn't widely available yet, which could potentially improve your heart rhythm if it proves more effective. However, as with any medical procedure, there are potential risks involved during both standard and hybrid ablation procedures, such as bleeding, infection, or other complications. The study doctors will explain these risks in detail. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

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

Ashford & St Peters Hospital NHS Trust
Verified postcode
Chertsey, United Kingdom· Recruiting
Epsom General Hospital
Verified postcode
Epsom, United Kingdom· Recruiting
Cromwell Hospital
Verified postcode
London, United Kingdom· Active not recruiting
Royal Surrey County Hospital
Verified postcode
London, United Kingdom· Recruiting
St Anthonys Hospital
Verified postcode
London, United Kingdom· Active not recruiting
St Georges at Kingston Hospital
Verified postcode
London, United Kingdom· Recruiting
St Georges University of London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is atrial fibrillation?

It's a type of irregular heartbeat where the upper chambers of your heart beat very fast and unevenly, making your heart less efficient.

What is heart failure?

Heart failure means your heart isn't pumping blood as strongly as it should, which can make you feel tired and breathless.

What is ablation?

Ablation is a procedure where doctors treat tiny areas in your heart to correct faulty electrical signals causing an irregular heartbeat.

Will I pick which treatment I get?

No, you'll be randomly assigned to either the standard or the new hybrid treatment, like flipping a coin, to ensure a fair comparison.

How long will I be involved in the study?

Your involvement in the study, including follow-up appointments, will last for about two years.

How to find out more

Riyaz A Kaba

rkaba@sgul.ac.uk 020 8725 4571 Official trial record

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