Active not recruitingOBSERVATIONAL

FARAPULSE Workflow Assessment Registry

This study, called the FARAPULSE Workflow Assessment Registry, is for people with an irregular heartbeat condition known as Atrial Fibrillation (AF). It's not a trial testing a new drug or device, but rather a way to understand and improve how doctors and hospitals use an existing treatment called the FARAPULSE Pulsed Field Ablation system in real-world settings. Researchers want to gather information on all the steps involved, from before the procedure to the follow-up, to find the most effective and safe ways to treat AF using this technology. The goal is to make the treatment process better for patients.

At a glance

Status

Active not recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

524

Start

06 May 2025

Estimated completion

15 Feb 2027

Atrial Fibrillation (AF)

What is this study about?

This registry is designed to help doctors understand and improve the way a treatment called Pulsed Field Ablation (PFA), using the FARAPULSE system, is used for people with an irregular heart rhythm condition called Atrial Fibrillation (AF). AF is when the upper chambers of your heart beat in a fast and disorganised way.

Instead of testing if the FARAPULSE system works – that's already known – this study focuses on the *process* of using it. Think of it like cooking: we know the recipe makes a good meal, but this study is about finding the best way to prepare it, from getting the ingredients ready to serving it. Doctors will look at things like how they prepare patients beforehand, the actual procedure itself, and what happens in the year after the treatment.

The main idea is to collect information about these different steps from many patients. By doing this, they hope to identify the most successful and safest methods for using the FARAPULSE system, depending on different patients' needs and heart conditions. This information can then help other doctors make treatment even better for future patients.

Key takeaways

This study focuses on improving the process of using an existing AF treatment.
It aims to find the best practices for FARAPULSE Pulsed Field Ablation.
Information will be collected on patient preparation, procedure, and follow-up.
The goal is to optimise treatment for future patients.
Participation involves observation of standard medical care.
You must be 18+ and planned for FARAPULSE treatment by your doctor.

Who may be eligible?

To be considered for this study, you would need to be an adult (age 18 or over, or legal age in your area) and your doctor must have decided that the FARAPULSE Pulsed Field Ablation system is the right treatment for your Atrial Fibrillation.

You also need to be willing and able to understand what the study involves and give your permission to take part. It's important that you can also attend appointments at one of the approved hospitals involved in the study.

However, you wouldn't be able to join if you're already participating in another medical study that might conflict with this one (unless it's a general observation study or a required government registry). Also, if you've already had a previous ablation procedure in the left upper chamber of your heart (Left Atrium Ablation), you wouldn't be eligible for this particular study.

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.

Am I 18 years old or older?
Has my doctor decided that the FARAPULSE system is right for my Atrial Fibrillation?
Am I willing and able to understand and agree to take part in a study?
Have I *not* had a heart ablation procedure on the left upper chamber of my heart before?
Am I *not* already in another medical study that might cause a problem with this one?

Answer every question to see your result.

What does participation involve?

If you take part in this study, your treatment for Atrial Fibrillation using the FARAPULSE system will be carried out as your doctor normally would. The study isn't changing your treatment, but rather observing it and collecting information about the entire process. This includes details from before your procedure, during the ablation itself, and during follow-up appointments set by your doctor for up to one year after the procedure. All the information collected will be about how the treatment was performed and how you're doing afterwards. There isn't any extra medication or specific new tests required just for the study, beyond what your doctor would usually recommend for your care.

Potential risks and benefits

Taking part in this study may not offer direct personal health benefits beyond receiving the treatment your doctor has already recommended, but it could help improve how this treatment is delivered for future patients. As with any medical procedure, there are potential risks associated with the Pulsed Field Ablation procedure itself, and these will be fully explained by your doctor. The study itself doesn't add new risks as it's observing standard care. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (28)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

A.o. Krankenhaus der Elisabethinen Linz
Verified postcode
Linz, Austria
Ziekenhuis aan de Stroom, Middelheim
Verified postcode
Antwerp, Belgium
Ziekenhuis Oost-Limburg
Verified postcode
Genk, Belgium
CHR de la Citadelle
Verified postcode
Namur, Belgium
CHU de Bordeaux
Verified postcode
Bordeaux, France
Hopital Saint Philibert
Verified postcode
Lomme, France
CHRU Hopital Trousseau
Verified postcode
Tours, France
Universitaetsklinikum Dusseldorf
Verified postcode
Düsseldorf, Germany
Staedtisches Klinikum Karlsruhe
Verified postcode
Karlsruhe, Germany
Munchen Klinik Bogenhausen
Verified postcode
München, Germany
Ippokrateio General Hospital of Athens
Verified postcode
Athens, Greece
Mitera Hospital
Verified postcode
Athens, Greece

Common questions

What is Atrial Fibrillation?

Atrial Fibrillation is a common condition where the upper chambers of your heart beat irregularly and fast, which can sometimes make you feel tired or breathless.

Is this a new treatment being tested?

No, the FARAPULSE system is an existing treatment for Atrial Fibrillation. This study is about understanding and improving how doctors use it.

What is 'Pulsed Field Ablation'?

It's a procedure that uses short, high-energy electrical pulses to create tiny scars in your heart tissue, which helps stop the irregular heartbeats causing Atrial Fibrillation.

Will I have extra appointments if I join?

No, your appointments will be the same as recommended by your doctor for your standard care. The study will just collect information from these visits.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any point, and your health care will not be affected.