First-line Cryoablation for Early Treatment of Persistent Atrial Fibrillation
This important UK study is for people aged 18-75 with persistent atrial fibrillation (AF), where the heart beats irregularly. We're comparing two main treatments: a procedure called cryoablation, where doctors freeze small areas in the heart to block abnormal electrical signals, and anti-arrhythmic medications, which help control heart rhythm. The study wants to know if early cryoablation is better than drugs at keeping the heart in a normal rhythm and improving a person's quality of life. Participants will be randomly assigned one of these treatments and followed for three years with regular check-ups, heart rhythm monitoring, and questionnaires to see how the treatments affect their health and daily lives.
At a glance
What is this study about?
Atrial fibrillation (AF) is a common heart condition that causes an irregular and often fast heart rate. This can lead to symptoms like palpitations, breathlessness, and tiredness. When AF lasts for more than seven days, or comes and goes over a long period, it's called persistent AF. While there are treatments, doctors are always looking for the best way to help people manage their condition and live well.
This study is investigating two main approaches for people with this type of AF. One is a procedure called cryoballoon ablation. This is a keyhole surgery where a small balloon is guided into the heart. The balloon is then inflated and cooled to very low temperatures to freeze and create tiny scars in specific areas of the heart called the pulmonary veins. These scars help block the faulty electrical signals that cause AF. The other approach is using anti-arrhythmic drugs, which are medications designed to help control the heart's rhythm and prevent AF episodes.
The main goal of the study is to see if having the cryoballoon ablation procedure early on is more effective than taking medication first. Researchers will specifically look at how many people stay free from AF and other irregular heart rhythms over three years. They will also compare how each treatment affects a person's quality of life, their overall health, and even how often they need to see a doctor or go to the hospital because of their AF. By carefully comparing these two treatments, the study aims to help doctors understand the best way to help people with persistent AF in the future.
Key takeaways
- This study compares freezing areas in the heart (cryoablation) with medication for persistent AF.
- It aims to find out which treatment is better at keeping a normal heart rhythm and improving daily life.
- Participants will be randomly assigned to one of the two treatments.
- The study involves three years of close monitoring, including a small implantable heart monitor.
- It's for people aged 18-75 with symptomatic persistent AF.
- Your decision to join is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for people aged 18 to 75 who have persistent atrial fibrillation (AF) that causes symptoms. This means your AF has either lasted longer than seven days (and less than a year) or has progressed from a type that used to come and go. You should have had at least two AF episodes in the last two years, with the most recent one in the last six months, and had your AF confirmed by a doctor.
You would not be able to join if you regularly take certain heart rhythm medications (though some are okay), have had previous AF surgery or ablation, or have severe heart failure or certain other serious heart conditions. Also, if you have very severe lung or kidney disease, or if you've had a recent heart attack, stroke, or major surgery, this study might not be suitable for you.
The researchers are looking for people who are generally well enough to undergo either the ablation procedure or take the study medications, and who are expected to live for at least three more years. Your doctor will carefully check all the details to see if this study is a good fit for you.
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 aged between 18 and 75?
- Do you have persistent atrial fibrillation (AF) that causes symptoms?
- Has your AF been confirmed by a doctor in the last 6 months?
- Have you NOT had previous AF surgery or ablation?
- Are you NOT currently taking certain strong heart rhythm medications daily?
- Do you NOT have severe heart failure or other very serious health conditions?
What does participation involve?
If you decide to take part, you'll first have a tiny heart monitor (like a small chip) placed just under the skin. This will continuously track your heart rhythm for two months before you start treatment and then for three years after. You will then be randomly assigned, like flipping a coin, to either have the cryoballoon ablation procedure or start taking anti-arrhythmic medication (such as Multaq™, Tambocor™, Rytmonorm™, or Sotacor™).
Throughout the three years, you'll have regular hospital visits for check-ups. These will include: heart scans (echocardiograms) to see how your heart is changing; filling out questionnaires about your quality of life; tests to check your memory and thinking; and discussions about your AF symptoms and any healthcare you've needed. Your doctors will also monitor for any side effects from your treatment. The tiny heart monitor will continue to record your heart rhythm throughout, sending information to the study team. The total duration of active follow-up for the study is three years.
Potential risks and benefits
Locations (6)
- Electrophysiology Department, Heart Institute, University of PecsVerified postcodePécs, Hungary
- Div. of Arrhythmia and Pacing, National Cardiovascular Institute, Faculty of Medicine, Slovak Medical UniversityVerified postcodeBratislava, Slovakia
- Institute of Medicine. Sahlgrenska Academy at University of GothenburgVerified postcodeGothenburg, Sweden
- Department of Cardiology, School of Medical Sciences, Faculty of Medicine and Health, Örebro UniversityVerified postcodeÖrebro, Sweden
- Department of Medical Science, Uppsala University HospitalVerified postcodeUppsala, Sweden
- Department of Cardiac Electrophysiology, Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest HospitalVerified postcodeLiverpool, United Kingdom
Common questions
What is 'atrial fibrillation'?
It's a common heart condition that causes an irregular and often fast heart rhythm, which can make you feel breathless or tired.
What is 'cryoballoon ablation'?
It's a keyhole procedure where doctors use cold to freeze small areas in your heart, stopping faulty electrical signals that cause AF.
What are 'anti-arrhythmic drugs'?
These are medications that help to control your heart's rhythm and prevent episodes of irregular heartbeat.
Will I get to choose my treatment?
No, you'll be randomly assigned to either the ablation procedure or medication, like flipping a coin, to ensure a fair comparison.
How long will I be involved in the study?
Your involvement will last for three years, with regular check-ups and monitoring during that time.
How to find out more
Carina M Blomstrom Lundqvist, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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