Cryoballoon/Radiofrequency/Pulsed Field Ablation of Atrial Fibrillation Versus Medical Treatment for Heart
This research is investigating the best treatment for an irregular heartbeat condition called atrial fibrillation (AF) when it occurs alongside heart failure. AF can make heart failure worse. Current treatments include medicines or a procedure called catheter ablation which helps to regulate heart rhythm. Previous smaller studies suggested ablation might be better than medicines, but they didn't include a wide range of patients. This large, international study will compare catheter ablation combined with standard medicines against medicines alone. The aim is to find out if ablation can reduce unplanned hospital stays for heart failure, lower death rates, and improve patients' overall quality of life. This will help doctors decide the best care for patients like you.
At a glance
What is this study about?
Heart failure is a serious condition where your heart can't pump enough blood around your body. Atrial fibrillation (AF) is a very common type of irregular heartbeat where your heart beats too fast and unevenly. If you have both AF and heart failure, the AF can make your heart failure symptoms worse.
Doctors currently have a few ways to treat AF. These include medicines to control your heart rate or rhythm, and a procedure called catheter ablation. For an ablation, a thin, flexible tube (catheter) is gently guided into your heart. It uses heat, cold, or electrical pulses to carefully create small scars that block the faulty electrical signals causing your irregular heartbeat, helping your heart beat normally again.
Some earlier, smaller studies hinted that catheter ablation might be more effective than just medicines in reducing hospital visits or even improving survival for some people with AF and heart failure. However, these studies were quite small and often focused on a very specific group of patients, so their results might not apply to everyone. This new, larger study aims to properly compare catheter ablation (along with medical treatment) against medical treatment on its own. The goal is to see if ablation truly helps reduce urgent hospital stays, lowers the chances of death, and improves how you feel day-to-day.
Key takeaways
- This study compares a heart procedure (ablation) with medicines for irregular heartbeats (AF) in people with heart failure.
- It aims to see if ablation reduces hospital stays and improves life quality and survival.
- You must have AF and heart failure and be on standard heart failure medications.
- Participation means being randomly assigned to a treatment group and attending regular check-ups.
- This is a large, international study seeking to find the best treatment approach.
- Joining is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and willing to take part for a full year. You'd also need to agree for your GP to be told about your involvement. Crucially, you must have been diagnosed with atrial fibrillation (AF). This includes AF that comes and goes on its own (paroxysmal) or AF that lasts longer than a week but less than three years (persistent).
You must also have heart failure with a specific type of reduced pumping ability of your heart (left ventricular ejection fraction below 50%). Importantly, you should already be receiving the best possible medical treatment for your heart failure for at least six weeks, even if you're not on the absolute highest doses of those medicines. Your heart failure symptoms should also fall into certain categories (NYHA class II or III).
If your heart's pumping ability is slightly better (between 41% and 49%), there's an additional blood test result (NT-proBNP) requirement that would need to be checked. The study team will review all your medical information carefully to see if you're a good fit.
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 a diagnosis of atrial fibrillation (AF)?
- Do you also have heart failure with a reduced pumping ability?
- Are you currently receiving standard medicines for your heart failure?
- Are you willing to take part in a study for at least 12 months?
What does participation involve?
If you decide to join this study, you would be randomly assigned to one of two groups: either you'd receive catheter ablation treatment along with your usual heart failure medicines, or you'd continue with your usual heart failure medicines only. You will not get to choose which group you are in. The study will last for at least 12 months, and you will have regular check-ups and assessments to monitor your heart health, how well you are feeling, and if you have any hospital stays. These visits will involve discussions about your health, quality of life questionnaires, and potentially some tests. The specific number and type of visits will be explained in detail by the study team.
Potential risks and benefits
Locations (24)
- Halifax InfirmaryVerified postcodeHalifax, Canada· Recruiting
- Mid and South Essex NHS Foundation TrustVerified postcodeBasildon, United Kingdom· Recruiting
- Queen Elizabeth HospitalVerified postcodeBirmingham, United Kingdom· Recruiting
- Blackpool Victoria HospitalVerified postcodeBlackpool, United Kingdom· Recruiting
- University Hospitals Dorset NHS Foundation TrustVerified postcodeBournemouth, United Kingdom· Recruiting
- Royal Papworth Hospital NHS Foundation TrustVerified postcodeCambridge, United Kingdom· Recruiting
- University Hospitals Coventry and Warwickshire NHS TrustVerified postcodeCoventry, United Kingdom· Recruiting
- Golden Jubilee National HospitalVerified postcodeGlasgow, United Kingdom· Recruiting
- Hull University Teaching Hospitals NHS TrustVerified postcodeHull, United Kingdom· Recruiting
- Leeds Teaching Hospitals NHS TrustVerified postcodeLeeds, United Kingdom· Recruiting
- Glenfield HospitalVerified postcodeLeicester, United Kingdom· Recruiting
- Liverpool Heart and Chest Hospital NHS Foundation TrustVerified postcodeLiverpool, United Kingdom· Recruiting
Common questions
What is atrial fibrillation (AF)?
It's a type of irregular and often fast heartbeat, which means your heart doesn't pump blood as effectively as it should.
What is catheter ablation?
It's a procedure where doctors use special tools to create tiny scars in your heart to block faulty electrical signals causing AF, helping your heart beat regularly.
What is heart failure?
It's a condition where your heart muscle can't pump enough blood to meet your body's needs.
Why is this study being done?
Doctors want to find out if catheter ablation is more effective than just medicines for people with both AF and heart failure in reducing hospital stays and improving their health.
Will I get to choose my treatment?
No, if you join, you will be randomly assigned to either receive ablation plus medicines, or medicines alone, like flipping a coin for fairness.
How to find out more
Pier Lambiase
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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