Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)
This study, called ORBICA-AF, is looking into the best way to treat a common irregular heartbeat problem called persistent atrial fibrillation (AF). We are comparing two main treatments: pulmonary vein isolation (a type of catheter ablation) and electrical cardioversion. Both aim to get your heart back into a normal rhythm. Currently, cardioversion is often tried first, but the irregular heartbeat often comes back. Catheter ablation is usually tried later. This trial wants to find out if having catheter ablation as an earlier treatment option can lead to fewer heart rhythm problems coming back compared to starting with cardioversion. We're looking for adults aged 18 to 85 who have persistent AF and are being considered for cardioversion.
At a glance
What is this study about?
If you have an irregular heartbeat that lasts for more than seven days, it’s called persistent atrial fibrillation, or AF. This can make you feel unwell, and doctors often try to get your heart back into a regular rhythm. Two common ways to do this are electrical cardioversion and catheter ablation.
Electrical cardioversion uses a controlled electrical shock to reset your heart's rhythm. It’s often used first because it can work quickly. However, for many people, the irregular heartbeat comes back later. Catheter ablation is a procedure where doctors use thin flexible tubes to create tiny scars in the heart muscle to block the faulty electrical signals causing the AF. This is often offered if cardioversion hasn't worked well or if your AF keeps returning.
The ORBICA-AF study wants to understand if starting with catheter ablation might be a better option for people with persistent AF than only using cardioversion. We want to see if one approach leads to your heart rhythm staying normal for longer without the AF coming back. By comparing these two strategies carefully, we hope to find out which treatment gives patients the best chance of a stable heart rhythm.
Key takeaways
- Compares two treatments for persistent atrial fibrillation (AF): electrical cardioversion vs. catheter ablation.
- Aims to find which treatment best keeps your heart in a normal rhythm for longer.
- Participation involves receiving one of these treatments and having a small heart monitor implanted.
- The study aims to improve future treatment decisions for AF patients.
- For adults aged 18-85 with persistent AF who are considering cardioversion.
Who may be eligible?
This study is looking for volunteers between 18 and 85 years old. You might be suitable if you have persistent atrial fibrillation (AF), which means your irregular heartbeat has lasted for more than seven days but for less than two years in total. Importantly, you should be a person who your doctor is already considering for electrical cardioversion.
There are also some reasons why you might not be able to join. For example, if you have severe kidney problems, are unable to take blood thinners, have very high blood pressure that isn't under control, or if you've already had more than one electrical cardioversion for persistent AF. Also, if there are reasons why you can't have the catheter ablation procedure, or if you have certain other heart conditions, you wouldn't be able to take part.
- Are you between 18 and 85 years old?
- Has your irregular heartbeat (AF) lasted for more than 7 days but less than 2 years in total?
- Is your doctor already considering cardioversion as a treatment for you?
- Do you not have severe kidney problems, uncontrolled high blood pressure, or other serious health issues mentioned by the doctors?
- Have you not had more than one electrical cardioversion for persistent AF before?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the study, you will be assigned to one of two treatment groups: either electrical cardioversion or catheter ablation (a procedure called pulmonary vein isolation). This will be decided randomly, like flipping a coin. You will need to take blood-thinning medication beforehand to prevent strokes, and your heart rate will be controlled as usual. The study also involves having a small device, an implantable loop recorder, placed under your skin. This device helps continuously monitor your heart rhythm to see how well the treatment is working. You will have regular check-ups and monitoring over time. The exact number of visits and the total duration of your participation will be explained in full by the study team.
Potential risks and benefits
Locations (1)
- Barts Heart CentreLondon, United Kingdom· Recruiting
Common questions
What is 'persistent atrial fibrillation'?
It's an irregular heartbeat (AF) that lasts for more than seven days at a time.
What is 'cardioversion'?
It's a procedure using an electrical shock to reset your heart to a normal rhythm.
What is 'catheter ablation'?
It's a procedure where doctors use thin tubes to fix faulty electrical signals in your heart that cause the irregular rhythm.
Why do you need to monitor my heart with a separate device?
The implantable loop recorder helps us keep a continuous check on your heart rhythm to see if the treatment keeps your heart steady.
Can I choose which treatment I receive?
No, if you join, you will be randomly assigned to either cardioversion or catheter ablation to ensure a fair comparison.
How to find out more
Malcolm Finlay, FRCP PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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