Active not recruitingNAINTERVENTIONAL

Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation

This research study is comparing two ways to treat persistent atrial fibrillation, a condition where your heart beats irregularly. One treatment uses a new approach called Pulsed Field Ablation (PFA), which uses brief electrical pulses. The other treatment involves common anti-arrhythmic drugs (AADs) like Flecainide or Sotalol, which help control heart rhythm. The main goal is to find out if pulsed field ablation is a safe and effective first treatment for people with persistent atrial fibrillation, especially when compared to starting with anti-arrhythmic drugs. The study will look at how well each treatment works and any side effects people experience.

At a glance

Status

Active not recruiting

Phase

Sponsor

Boston Scientific Corporation

Enrolment target

484

Start

28 Dec 2023

Estimated completion

04 Feb 2028

Persistent Atrial Fibrillation

What is this study about?

This study is looking into the best way to treat a heart condition called persistent atrial fibrillation. In this condition, the upper chambers of your heart beat irregularly and quickly for an extended period. Doctors want to see if a newer treatment called pulsed field ablation (PFA) is a good option as a first treatment, compared to the more traditional approach of using anti-arrhythmic drugs (AADs).

Pulsed field ablation is a procedure where doctors use a special catheter (a thin, flexible tube) to deliver very short electrical pulses to specific parts of the heart. The aim is to create tiny scars that block the abnormal electrical signals causing the irregular heartbeat, helping your heart return to a normal rhythm. Anti-arrhythmic drugs, on the other hand, are medications you take to help control your heart's rhythm.

The study involves people being randomly assigned to either receive the pulsed field ablation or start on anti-arrhythmic drugs. The doctors will then closely monitor how each treatment works, whether it helps control the atrial fibrillation, and if there are any side effects. This research is important because it could help doctors decide which treatment is most effective and safest for people when they are first diagnosed with persistent atrial fibrillation.

Key takeaways

This study compares a new heart treatment (PFA) with existing drugs (AADs) for persistent atrial fibrillation.
It aims to find out which approach is safer and more effective as a first treatment.
You'll be randomly assigned to receive either pulsed field ablation or anti-arrhythmic drugs.
Participation involves having a small heart monitor inserted under your skin.
Close monitoring and regular follow-up appointments are part of the study.
Your involvement is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have had symptomatic persistent atrial fibrillation for more than 7 days but less than a year. Your doctor would have confirmed this condition through heart rhythm recordings and notes.

You also need to be able to understand what the study involves, give your permission to take part, and be willing to attend all study appointments. A key requirement is that you must be willing to have a small heart monitor (called a LUX-Dx™ insertable cardiac monitor) placed under your skin, or you might already have one that was put in within the last six months.

There are also reasons why you might not be able to join. For example, if you've recently taken certain heart rhythm medications (AADs) in the last six months, or if those drugs didn't work for you in the past. You also can't participate if you have certain other heart conditions, if you can't take blood thinners, or if doctors think pulsed field ablation might not be safe 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 18 years old or older?
Have you been diagnosed with symptomatic persistent atrial fibrillation for more than seven days but less than a year?
Are you able to get a small heart monitor (ICM) inserted, or do you already have one from the last six months?
Have you avoided certain heart rhythm medications (AADs) in the last six months, or did they not work for you previously?
Can you safely take blood thinners if needed?
Do you not have a very enlarged heart (left upper chamber)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first either be randomly chosen to receive the pulsed field ablation (PFA) or to start on anti-arrhythmic drugs (AADs). This means a computer will decide which treatment you get, like flipping a coin. If you're chosen for PFA, you'll have a procedure to treat your heart. If you're chosen for AADs, you'll be prescribed medication and your doctors will adjust the dose to find what works best for you and keeps your heart rate regular. If the AADs don't work or cause problems, you might then be offered the ablation procedure later.

Throughout the study, you'll have regular check-ups and your heart rhythm will be continuously monitored using a small device placed under your skin called an insertable cardiac monitor. This monitor helps your doctors keep track of your heart's activity. The study will involve multiple visits to the clinic for assessments and monitoring. The total duration of your involvement in the study will be determined by the researchers and explained to you in detail.

Potential risks and benefits

Taking part in this study could offer some potential benefits. You would receive close monitoring of your atrial fibrillation and access to either a new treatment approach or carefully managed standard drug therapy. Both treatments aim to improve your heart rhythm and symptoms. However, like all medical procedures and medications, there are potential risks involved. Pulsed field ablation carries risks such as bleeding, infection, or damage to surrounding heart structures, while anti-arrhythmic drugs can have side effects that vary depending on the specific medication. Your doctor will explain all potential risks in detail. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (62)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Banner University Medical Center Phoenix
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Phoenix, United States
Phoenix Cardiovascular Research Group
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Phoenix, United States
Arrhythmia Research Group
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Jonesboro, United States
Scripps Memorial Hosptial
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La Jolla, United States
Stanford University Medical Center
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Palo Alto, United States
Cardiology Associates Medical Group, Inc
Verified postcode
Ventura, United States
HCA Florida Mercy Hospital
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Miami, United States
Sarasota Memorial Hospital
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Sarasota, United States
Tallahassee Memorial Hospital
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Tallahassee, United States
St. Joseph's Hospital
Verified postcode
Tampa, United States
Emory University Hospital
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Atlanta, United States

Common questions

What is 'persistent atrial fibrillation'?

It's a type of irregular heartbeat where your heart's upper chambers beat quickly and chaotically for more than seven days, and often won't return to a normal rhythm on its own.

What is pulsed field ablation (PFA)?

It's a procedure where doctors use short bursts of electricity to create tiny scars in your heart to block faulty electrical signals causing the irregular rhythm.

What are anti-arrhythmic drugs (AADs)?

These are medications, like Flecainide or Sotalol, that help control and regulate your heart's rhythm.

Will I get to choose my treatment?

No, in this study, you will be randomly assigned to either receive the pulsed field ablation or start on anti-arrhythmic drugs, like flipping a coin.

What is an insertable cardiac monitor (ICM)?

It's a tiny device placed just under your skin that continuously records your heart's electrical activity, helping doctors track your rhythm over time.