RecruitingNAINTERVENTIONAL

Surgical Ablation of AF Efficacy Trial

This study, called SAFE, is for people having heart surgery who also have an irregular heartbeat called atrial fibrillation (AF). AF can increase the risk of stroke and even worsen heart failure. The study wants to see if adding a special surgical procedure to treat AF during their scheduled heart surgery can make a difference. This procedure involves carefully creating 'scars' in a part of the heart to correct its electrical signals. The main aim is to find out if this extra procedure can reduce how often people are readmitted to hospital for heart failure after their initial heart surgery. The study will involve 2000 patients worldwide and follow them for about four years to track their health and recovery.

At a glance

Status

Recruiting

Phase

Sponsor

Population Health Research Institute

Enrolment target

2,000

Start

01 Jun 2023

Estimated completion

31 Dec 2026

Atrial Fibrillation Heart Failure

What is this study about?

Heart surgery can be a big event, and sometimes people who need heart surgery also have another condition called atrial fibrillation, or AF. AF is a very common type of irregular heartbeat where the upper chambers of the heart beat chaotically instead of in a steady rhythm. This can make you feel tired or breathless, and importantly, it increases your risk of stroke. It can also be linked with heart failure, a condition where your heart doesn't pump blood as well as it should.

This study, called SAFE, is looking at whether a specific surgical treatment for AF, called 'surgical ablation', can help people who are already having heart surgery for other reasons. Surgical ablation involves a surgeon carefully creating tiny scars in the heart tissue to block the incorrect electrical signals that cause AF. By doing this, the hope is to restore a normal heart rhythm. Other ways to treat AF already exist, but this study focuses on whether doing surgical ablation at the same time as another heart operation is a good idea.

Researchers want to see if adding this AF ablation procedure during an existing heart operation can prevent people from being readmitted to hospital for heart failure in the years after their surgery. By comparing patients who receive the additional AF procedure with those who don't, the study aims to provide clear answers about the long-term benefits of this combined approach for people with both heart conditions.

Key takeaways

This study evaluates an extra surgical step to treat irregular heartbeats during heart surgery.
It aims to see if this procedure reduces hospital readmissions for heart failure.
Participants will be followed for about four years after their surgery.
Your participation helps improve treatment for future patients with similar conditions.
You won't know if you received the additional procedure to keep results fair.

Who may be eligible?

This study is looking for adults aged 18 or older who are already scheduled to have certain types of heart surgery, such as a coronary artery bypass graft (CABG), aortic valve replacement, or surgery for their main artery (aorta). You would also need to have a confirmed diagnosis of atrial fibrillation (AF), which means you have had an irregular heartbeat that comes and goes, or is always present.

There are also some reasons why you might not be able to join. For example, if your irregular heartbeat is mainly a different type called 'atrial flutter', or if a specific part of your heart (the left atrium) is very enlarged. Patients who have had previous heart surgery where the protective sac around the heart was opened would also not be able to participate.

Finally, some specific heart operations are not included in this study, such as heart transplants, most surgeries involving the mitral or tricuspid heart valves, or if you live in a long-term care facility. The study team will check all these details with you and your doctors to make sure it's the right 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?
Are you already scheduled for heart surgery for conditions like CABG or aortic valve issues?
Have you been diagnosed with atrial fibrillation (irregular heartbeat)?
Have you NOT had previous heart surgery that involved opening the sac around your heart?
Are you NOT having a heart transplant or most mitral/tricuspid valve surgeries?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive an additional surgical procedure to treat your atrial fibrillation during your planned heart operation, or you will have your planned heart operation without that extra AF procedure. Which group you are in will be decided randomly, like flipping a coin. You won't know which group you are in, and your doctors won't know either.

After your heart surgery, the study team will keep track of your health over approximately four years. This will involve regular check-ups. You'll have visits after you leave the hospital, then again about 4 to 6 weeks after surgery, followed by a 6-month check. After that, you'll have appointments every six months until the end of the study. These visits will help the researchers understand how you are recovering and how your heart is doing.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this study, if you are in the group that receives the additional AF ablation, there's a chance it could help keep your heart rhythm regular, potentially reducing your risk of future heart problems like heart failure. Even if you don't receive the extra ablation, your participation helps researchers learn valuable information that could benefit many other patients in the future. As with any surgery, there are risks involved with the main heart operation you are having, and adding an additional procedure could carry its own small additional risks, which your surgeon will discuss. You have the right to withdraw from the study at any time, for any reason, and this will not affect your medical care.

Locations (1)

Hamilton General Hospital
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is 'atrial fibrillation'?

It's a common type of irregular heartbeat where the upper chambers of your heart beat out of sync, which can make you feel breathless or tired.

What is 'surgical ablation'?

It's a procedure where a surgeon carefully creates tiny scars in the heart tissue to correct the faulty electrical signals causing the irregular heartbeat.

Will I know if I receive the extra procedure?

No, neither you nor your doctors will know if you received the additional AF ablation or not. This helps ensure the study results are unbiased.

How long will I be followed in the study?

You will be followed for about four years after your heart surgery, with regular check-ups to monitor your health.

What happens if I change my mind?

You are free to leave the study at any time without having to give a reason, and it will not affect your medical care.

How to find out more

Richard Whitlock

richard.whitlock@phri.ca 905-521-2100 Official trial record

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