Multicenter and randomised study on atrial fibrillation prevention after cardiac surgery with a 3-way comparison between standard of care, posterior pericardiotomy and a treatment bundle (colchicine, amiodarone and posterior pericardiotomy) (PREV-AF)
Having heart surgery can sometimes trigger an irregular and fast heartbeat called atrial fibrillation (AF). While AF is very common after surgery, it can slow down your recovery and mean a longer hospital stay. This clinical trial, called PREV-AF, is testing different ways to protect patients from developing AF after their operation. Doctors are comparing three approaches. The first is usual standard care. The second involves a small cut made in the sac around the heart during surgery to stop fluid building up. The third combines this small cut with heart medicines called colchicine and amiodarone. Researchers want to find out which treatment is safest and most effective at keeping your heart beating steadily during the first week of recovery. The results could help doctors improve standard care for people having heart surgery in the future.
At a glance
What is this study about?
When people have heart surgery, the heart muscle can become irritated as it heals. This irritation often triggers a condition known as atrial fibrillation, or AF. In AF, the upper chambers of the heart beat irregularly and often too quickly. While it is a well-known and treatable complication, it can cause tiredness, shortness of breath, and a higher risk of blood clots. It can also mean you have to stay in hospital for longer than planned.
Doctors currently have several ways to lower the risk of AF, but they want to know if specific techniques work better than others. One method involves making a tiny slit in the sac surrounding the heart, called a posterior pericardiotomy. This allows normal fluid that collects after surgery to drain away safely, reducing pressure and swelling around the heart. Another option is using medicines that soothe swelling and help maintain a steady heart rhythm.
This trial compares three groups of patients: those receiving standard care alone, those having the small fluid-draining cut during their operation, and those receiving both the cut and a combination of medications. By comparing these groups, doctors hope to discover the best, safest way to prevent irregular heart rhythms and help people recover more quickly after surgery.
Key takeaways
- The PREV-AF trial tests ways to prevent irregular heartbeats after heart surgery.
- It compares standard care against a surgical fluid-draining technique and a combination of that technique with heart medicines.
- Heart rhythm will be closely watched during your first week in hospital.
- The study is open to adults having heart surgery.
- Taking part is voluntary, and you can leave at any time without affecting your NHS care.
Who may be eligible?
This study is open to adults aged 18 and over who are scheduled to have heart surgery. Both men and women can take part. Because it focuses on preventing heart rhythm problems that happen straight after an operation, participants will join the study around the time of their planned procedure.
Not everyone having heart surgery will be suitable. Doctors will carefully check your overall health, the exact type of surgery you are having, and whether your heart already has a history of long-term rhythm issues. They will also make sure that the trial medicines are safe for you to take alongside any regular prescriptions.
Your surgical team and cardiologist will review your medical records to confirm if this trial is an option for you. If you are interested, your hospital team can discuss your full eligibility before you make any decisions.
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.
- I am aged 18 or older.
- I am scheduled to have heart surgery.
- I am willing to take part in heart monitoring while recovering in hospital.
- I am happy to take trial medications if assigned to that group.
- I have discussed my medical history with my surgical team.
What does participation involve?
If you take part, you will be placed into one of three treatment groups by chance, like flipping a coin. You will either receive standard hospital care, have the small surgical cut during your planned operation, or receive the cut along with medications such as amiodarone and colchicine. You will also receive routine post-surgery medicines, such as blood thinners or beta-blockers, as part of normal care.
While you recover in hospital, your heart rhythm will be monitored continuously using special monitors and heart traces (ECGs), particularly over the first seven days. The team will track any symptoms, how long you need to stay in hospital, and your general recovery.
After you go home, you will have standard check-ups with your cardiologist, just as you would after normal heart surgery. You will not usually need extra hospital visits beyond your normal follow-up care, and your doctors will continue to check your heart health and medications.
Potential risks and benefits
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Common questions
What is atrial fibrillation?
Atrial fibrillation is a common heart condition that causes an irregular and often abnormally fast heartbeat.
Will I need an extra operation?
No. Any surgical technique tested in this study is performed during your already planned heart operation while you are asleep.
Can I choose which treatment group I am in?
No. A computer chooses your group at random to ensure the comparison between treatments is completely fair.
What happens if I develop an irregular heartbeat during the trial?
The hospital team will treat you immediately using standard medical care to help your heart return to its normal rhythm.
Will taking part change my normal recovery at home?
In most cases, your recovery and clinic appointments will follow the same routine path as any other patient having heart surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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