CompletedInterventional

Hybrid ablation of atrial fibrillation in heart failure

This study is for adults with a type of irregular heartbeat called persistent atrial fibrillation, particularly if they also have heart failure. It aims to find out if a newer treatment, called 'convergent hybrid ablation,' is a safer and more effective way to control this condition compared to the standard 'catheter ablation.' Both treatments are already used in hospitals. Participants will be randomly chosen to receive one of these treatments, and researchers will collect information for up to two years to see which works best. The study helps doctors understand the best way to treat these conditions and improve patients' quality of life.

At a glance

Status

Completed

Sponsor

City St George's, University of London

Enrolment target

120

Start

01 May 2022

Estimated completion

01 May 2026

Persistent atrial fibrillation, heart failure

What is this study about?

This study is looking into better ways to treat a common heart condition called atrial fibrillation (AF), especially when someone also has heart failure. Atrial fibrillation causes your heart to beat irregularly, which can make you feel tired, breathless, or generally unwell, and can really affect your daily life.

Currently, there are two main ways doctors might treat AF with a procedure: one is a standard 'catheter ablation' and the other is a 'hybrid ablation.' Both procedures aim to correct the irregular heart rhythm. This study wants to compare these two treatments to see which one is safer and works better for controlling AF in people who also have heart failure. By finding out which treatment is superior, doctors can make more informed decisions about how to help their patients feel better.

Taking part in this study means you would be randomly assigned to receive either the hybrid ablation or the standard catheter ablation. Both of these treatments are already options available in regular care. The researchers will then carefully follow your progress for up to two years to see how well the treatment worked for you and to check for any side effects.

Key takeaways

Compares two existing procedures (hybrid vs. catheter ablation) for atrial fibrillation.
Specifically for adults with persistent atrial fibrillation and heart failure.
Participants will be randomly assigned to one of the two treatments.
Follow-up for up to 2 years to see which treatment works best.
Treatments are already available as part of standard care.
Aims to improve treatment for AF, especially for those with heart failure.

Who may be eligible?

This study is for adults aged 18 or over who have persistent atrial fibrillation and also heart failure. You would typically already be considered for an ablation procedure by your doctor. Your heart's main pumping chamber (the left ventricle) should not be working at its full strength, and your left atrium (one of the heart's upper chambers) may be enlarged.

You cannot take part if you've already had open-heart surgery, or a previous catheter ablation specifically for atrial fibrillation. You also can't join if you've recently had a heart attack or stroke within the last three months, have certain other serious health conditions, or are pregnant or planning to become pregnant very soon.

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?
Do you have persistent atrial fibrillation?
Do you also have heart failure?
Has your doctor suggested you might need an ablation procedure?
Have you NOT had previous open-heart surgery or ablation for AF?
Are you NOT pregnant or planning to be within 6 months?

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 one of two common heart procedures: either a 'convergent hybrid ablation' or a 'standard catheter ablation.' The hybrid ablation involves two stages, treating the heart from both the outside and inside, while the standard catheter ablation is a single procedure usually done through a vein in your groin. Both these treatments are standard options offered in routine care.

After your procedure, a dedicated research team will keep in touch with you. They will collect information about your health and how you're feeling for up to 24 months (two years). This will involve regular follow-up appointments and checks to see how well the treatment is working for you.

Potential risks and benefits

Participating in this study means you would receive one of two treatments that are already part of standard medical care for your condition, so you are not receiving an experimental treatment. A potential benefit is that you will have close contact with a dedicated research team who will carefully monitor your health and recovery over a two-year period. However, as with any medical procedure, there are potential risks associated with both hybrid and catheter ablation. Your doctor will discuss these risks with you in detail. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (6)

St Georges Hospital
City only
London, United Kingdom
Ashford and St Peter's Hospitals NHS Foundation Trust
City only
Chertsey, United Kingdom
Epsom Hospital
Approximate
Epsom, United Kingdom
St Georges at Kingston Hospital
City only
Kingston upon Thames, United Kingdom
St Anthony's Hospital
Unverified
United Kingdom
Cromwell Hospital
Approximate
London, United Kingdom

Common questions

What is atrial fibrillation?

It's an irregular and often fast heartbeat that can make you feel tired or unwell.

What is heart failure?

It means your heart isn't pumping blood as effectively as it should, leading to symptoms like breathlessness.

What is 'ablation'?

It's a procedure where doctors treat tiny areas of your heart to correct an irregular heartbeat.

How long will the study last for me?

If you participate, researchers will collect information about you for up to two years after your procedure.

Where is the study happening?

The study is being run from St George's University Hospital in the UK.

How to find out more

Rosie Jacobs

researchgovernance@sgul.ac.uk +44 (0)20 8725 4571 Official trial record

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