AF Ablation With High Power Short Duration RF
This research study is investigating a new and potentially better way to treat atrial fibrillation (AF), a condition where the heart beats irregularly. The study focuses on a procedure called catheter ablation, where doctors use heat (radiofrequency energy) to create tiny scars in a part of the heart to block faulty electrical signals that cause AF. Specifically, they are testing a method that uses high power for a short time to perform the ablation. Researchers want to see how safe and effective this technique is in preventing AF from returning in patients with paroxysmal (comes and goes) or persistent (ongoing) AF. They will follow participants for 12 months to understand the success rates and any factors that might predict whether the AF comes back.
At a glance
What is this study about?
This important research study is focusing on a common heart condition called atrial fibrillation, or AF. In AF, the heart's upper chambers beat irregularly, which can lead to symptoms like palpitations, tiredness, and breathlessness. One of the main treatments for AF is a procedure called catheter ablation. This involves guiding a thin, flexible tube (catheter) into the heart, usually through a vein in the leg, and using small bursts of heat (radiofrequency energy) to create tiny scars. These scars block the faulty electrical signals that cause AF, helping the heart return to a normal rhythm.
This particular study is looking at a new approach to catheter ablation. Instead of using lower power for a longer time, doctors are testing a method that uses 'high power for a short duration'. The aim is to see if this new technique is both safe and more effective at preventing AF from coming back. By investigating this, researchers hope to improve how AF is treated, potentially offering a more efficient and successful procedure for patients.
They will be closely monitoring how patients respond to this ablation over a year. This helps them understand what factors contribute to the AF staying away or returning. The results of this study could help doctors across the UK and beyond choose the best treatment options for people living with atrial fibrillation.
Key takeaways
- This study explores a new, faster way to perform AF ablation.
- It aims to find out if this new method is safe and effective in preventing AF recurrence.
- Participants will be followed for 12 months to monitor their heart rhythm.
- The research could lead to improved AF treatments for future patients.
- Participation involves a catheter ablation procedure and follow-up appointments.
Who may be eligible?
To join this study, you would need to have been diagnosed with either paroxysmal AF (meaning your AF comes and goes) or persistent AF (meaning your AF is ongoing). You also need to be taking anticoagulant medication, which helps prevent blood clots. Importantly, you'll need to read and sign a consent form, showing you understand the study and agree to take part.
There are also reasons why you might not be able to join. For example, if you've already had an ablation procedure for AF in the past or if your heart's pumping function (LVEF) is less than 35%, you wouldn't be able to participate. If you are a woman who could become pregnant, or if you have certain heart problems like congenital heart disease or have had heart surgery within the last month, you wouldn't be able to join either. Also, if there are medical reasons you can't be exposed to X-rays, you would not be eligible.
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.
- Do you have paroxysmal (comes and goes) or persistent (ongoing) atrial fibrillation?
- Are you currently taking blood-thinning medication?
- Have you *not* had an AF ablation before?
- Is your heart's pumping strength generally healthy (LVEF 35% or more)?
- Are you between 18 and 80 years old, male or female?
- Do you have no other serious heart conditions or recent heart surgery?
What does participation involve?
If you decide to take part, you'll first have screening appointments to make sure the study is right for you. Your existing blood-thinning medication (anticoagulation) will usually continue, though any anti-arrhythmic drugs you're taking may be stopped before the procedure. Depending on your health, you might have a special heart scan called a transoesophageal echocardiogram before the ablation. Additional scans like a cardiac MRI or CT might also be done.
The ablation procedure itself will be carried out in hospital. You’ll be given medication to help you relax (mild or deep sedation) or a general anaesthetic. During the procedure, doctors will place special catheters into your heart, usually through veins in your leg, to map your heart's electrical signals and perform the ablation. After the procedure, you will have follow-up appointments over 12 months to monitor your heart rhythm and see if the AF has returned. The study aims to enrol at least 850 patients.
Potential risks and benefits
Locations (9)
- Centre Cardiologique Du NordVerified postcodeParis, France· Recruiting
- Clinica MontevergineVerified postcodeMercogliano, Italy· Recruiting
- Maria cecilia HospitalVerified postcodeCotignola, Italy· Recruiting
- Ospedale di ConeglianoVerified postcodeConegliano, Italy· Recruiting
- Università Politecnica delle MarcheVerified postcodeAncona, Italy· Recruiting
- Ospedale Civile di AstiVerified postcodeAsti, Italy· Recruiting
- Clinica MediterraneaVerified postcodeNaples, Italy· Recruiting
- Città della Salute e della Scienza di Torino, Dipartimento di Scienze Mediche della Università di Torino.Verified postcodeTorino, Italy· Not yet recruiting
- Royal Papworth HospitalVerified postcodeCambridge, United Kingdom· Not yet recruiting
Common questions
What is atrial fibrillation (AF)?
AF is a common heart condition where the upper chambers of the heart beat irregularly, causing symptoms like palpitations or tiredness.
What is catheter ablation?
It's a procedure where doctors use heat or cold to create tiny scars in the heart to block faulty electrical signals causing AF.
What does 'high power short duration' mean for this ablation?
It refers to a new method where the energy used to create the scars is delivered at a higher power for a shorter amount of time.
How long will I be followed after the procedure?
You will be monitored by the study team for 12 months after your ablation to see how you are doing.
Will I have to stop my current medications?
Your anti-arrhythmic medications might be stopped before the procedure, but your blood thinners (anticoagulation) will usually continue.
How to find out more
Giuseppe Stabile, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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