A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation
This research study is about finding the best way to treat a common heart problem called persistent atrial fibrillation (AF). In AF, the heart beats irregularly, which can make you feel unwell. The study is testing a modern treatment called pulsed field ablation (PFA). This treatment uses controlled electrical pulses to target the tiny areas in the heart that are causing the irregular beat. Doctors want to compare two different ways of using PFA: one where they focus on specific areas identified by a new mapping system, and another where they also treat a larger back wall area of the heart. The main goal is to find out if the new targeted approach is just as safe and effective at bringing the heart rhythm back to normal in people who haven't found relief with other treatments.
At a glance
What is this study about?
If your heart sometimes beats out of rhythm, you might have something called atrial fibrillation (AF). When this irregular heartbeat lasts for a while, it's called persistent AF. This can make you feel tired, breathless, or have chest discomfort. Doctors are always looking for better ways to help people with this condition. This study is testing a treatment called pulsed field ablation, which is a modern way to fix the heart's electrical signals that cause AF.
The study aims to compare two slightly different approaches to pulsed field ablation. One approach involves carefully mapping the heart to find the exact spots causing the problem and treating those. The other approach involves treating those spots plus a larger area of the back wall of the heart. The main reason for doing this study is to see if the more targeted approach is as safe and effective as the other, potentially helping fewer areas of the heart need treatment.
Ultimately, this research matters because it could lead to better and safer treatment options for people living with persistent atrial fibrillation, helping them get their heart rhythm back on track and improving their quality of life. Participants will have their heart rhythm carefully monitored throughout the study to see how well the treatment works.
Key takeaways
- This study is for people with persistent atrial fibrillation that hasn't responded to medication.
- It's comparing two slightly different ways of performing a treatment called pulsed field ablation.
- The goal is to find a safer and more effective way to bring the heart back into a normal rhythm.
- Participation involves a heart procedure and continuous heart monitoring.
- You must be 18 or older and meet specific health criteria to be eligible.
Who may be eligible?
To join this study, you generally need to be 18 years or older and have what doctors call "symptomatic drug-refractory persistent atrial fibrillation." This means your irregular heartbeat has been happening for at least 7 days but no more than a year, it's causing you symptoms, and medicines haven't helped enough. Doctors will need to see proof of your persistent AF from medical records, like an ECG or a 24-hour heart monitor.
You also need to be willing to participate fully, including attending follow-up appointments and having a small heart monitor (called a LUX-Dx ICM) placed under your skin, or already have one that was put in fairly recently (within the last 6 months). This monitor helps doctors keep track of your heart rhythm over time.
There are also some reasons why you might not be able to join. For example, if you've had previous heart ablation procedures or heart surgery, or if you have certain other heart conditions like a very enlarged left atrium, a blood clot in your heart, or a history of serious fast heart rhythms from the bottom chambers of your heart. If your AF is caused by things like an overactive thyroid or alcohol, or if you have a pacemaker or defibrillator, you also wouldn't be able to join.
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?
- Has your irregular heartbeat (persistent AF) been continuous for more than 7 days but less than a year, and is it causing you symptoms?
- Have medications not been able to control your AF well enough?
- Are you willing to have a small heart monitor inserted under your skin or do you already have one that was put in recently?
- Have you *not* had any previous heart ablation procedures or certain other heart conditions like a very enlarged heart chamber or blood clots?
- Are you willing and able to attend all study appointments?
What does participation involve?
If you join this study, you'll undergo a heart procedure called pulsed field ablation. You will be assigned to one of two different ways this procedure is performed. After the procedure, you'll have regular follow-up appointments with the study team to check your heart's rhythm and overall health. You will also have a small heart monitor (LUX-Dx ICM) inserted under your skin, or already have one, which will continually record your heart's activity and send the information to the study team. This monitor helps doctors keep a close eye on how well the treatment is working over a longer period. The total duration of your participation in the study, including follow-up, will be determined by the study design, but generally involves monitoring for a significant period to assess long-term effectiveness.
Potential risks and benefits
Locations (41)
- Grandview Medical CenterVerified postcodeBirmingham, United States· Not yet recruiting
- Mercy Gilbert Medical CenterVerified postcodeGilbert, United States· Not yet recruiting
- Banner University Medical CenterVerified postcodePhoenix, United States· Not yet recruiting
- Arrhythmia Research GroupVerified postcodeJonesboro, United States· Recruiting
- Alta Bates Summit Medical Center-HospitalVerified postcodeOakland, United States· Recruiting
- Stanford University Medical CenterVerified postcodePalo Alto, United States· Not yet recruiting
- Pacific Heart InstituteVerified postcodeSanta Monica, United States· Recruiting
- St. Vincent's Medical CenterVerified postcodeJacksonville, United States· Not yet recruiting
- Piedmont Athens RegionalVerified postcodeAthens, United States· Not yet recruiting
- Emory University HospitalVerified postcodeAtlanta, United States· Recruiting
- St. Luke's Boise Medical CenterVerified postcodeBoise, United States· Recruiting
- Endeavor HospitalVerified postcodeGlenview, United States· Not yet recruiting
Common questions
What is atrial fibrillation?
Atrial fibrillation is a common type of irregular heartbeat where the upper chambers of your heart beat quickly and out of rhythm.
What is pulsed field ablation?
Pulsed field ablation is a modern treatment that uses very specific electrical pulses to stop the abnormal signals in your heart that are causing the irregular heartbeat.
What does 'drug-refractory' mean?
It means that medicines you've tried haven't been able to control your irregular heartbeat effectively enough.
Will I know which treatment group I'm in?
The study aims to compare two approaches, and often in such studies, you may not know which specific approach you receive until after the study is complete, or you will be informed by the study team as appropriate.
What is an insertable cardiac monitor (ICM)?
It's a very small device placed just under your skin that continuously records your heart's electrical activity to check for irregular rhythms over time.
How to find out more
Jackie Lin
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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