Active not recruitingOBSERVATIONAL

A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation

This study is gathering real-world information about a new treatment for an irregular heartbeat called atrial fibrillation. The treatment uses something called the FARAPULSE™ Pulsed Field Ablation System. During the procedure, doctors use a special tool called the FARAWAVE NAV Ablation Catheter together with a mapping system called OPAL HDx. The main goal is to see how safe and effective this treatment is over one year in people who are having it as part of their regular care. Researchers also want to understand how different aspects of the procedure, like how doctors map the heart, relate to any problems that might come up and how well the treatment works in the long run.

At a glance

Status

Active not recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

550

Start

30 Jul 2025

Estimated completion

01 Apr 2027

Atrial Fibrillation Pulsed Field Ablation FARAPULSE

What is this study about?

This study is designed to help us understand more about a new way to treat an irregular heartbeat condition called atrial fibrillation. Many people live with atrial fibrillation, where the heart beats too fast, too slow, or unevenly, which can make you feel tired, dizzy, or breathless. This new treatment, called Pulsed Field Ablation (using the FARAPULSE™ system), aims to gently correct these irregular heart signals.

Doctors are collecting information when they use the FARAPULSE system in their daily practice. They're particularly interested in how safe it is and how well it works over one year after the treatment. This includes looking at how specific tools, like the FARAWAVE NAV catheter and OPAL HDx mapping system, are used together during the procedure. By gathering this real-world data, the study helps doctors and patients understand the treatment better.

The study also looks at how different steps during the procedure might affect how safe the treatment is and how effective it is in the long term. This helps improve the way the treatment is given, making it safer and more successful for future patients. It’s all about making sure that new heart treatments are as good as they can be.

Key takeaways

This study collects real-world information about a new atrial fibrillation treatment.
It focuses on the safety and effectiveness of the FARAPULSE™ system for one year.
Data collected will help improve future patient care.
Participation involves having the FARAPULSE™ treatment as part of your standard care.
You will be followed for one year after your procedure.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older, and have atrial fibrillation. Your doctor must believe that the FARAPULSE™ Pulsed Field Ablation system is the right treatment for you, and it needs to be part of the standard care offered at the hospital.

You also need to be willing to understand and sign a consent form, showing you agree to take part. It's important that you can also attend appointments at the approved study centre.

You cannot join if you are already taking part in another research study that would directly interfere with this one. However, if you're in a national health registry or a study that's just observing things without affecting your treatment, that might be okay.

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?
Do you have atrial fibrillation?
Has your doctor decided the FARAPULSE™ treatment is right for you?
Are you willing and able to attend follow-up appointments?
Are you not currently in another medical study that would interfere with this one?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the FARAPULSE™ Pulsed Field Ablation treatment as planned by your doctor. The study itself mainly involves collecting information about your treatment and recovery. This means doctors will gather data about your health and how you're doing after the procedure, including how safe the treatment was and how well it worked for your atrial fibrillation.

You will have follow-up visits and assessments as part of your usual care, and the study will gather information from these visits for one year after your procedure. There aren't any extra medications or special tests just for the study, beyond what your doctor would normally recommend for this treatment. The total duration of data collection for the study will be one year from your treatment date.

Potential risks and benefits

Taking part in this study means that your treatment information will help us learn more about the FARAPULSE™ system for atrial fibrillation. This could benefit future patients by improving our understanding of the treatment's safety and effectiveness in the long term. Like any medical procedure, there are potential risks associated with the ablation treatment itself. These will be fully explained by your doctor before you agree to the procedure. You will also have the right to withdraw from the study at any time without it affecting your medical care.

Locations (22)

Allgemeines Krankenhaus AKH
Verified postcode
Vienna, Austria
CHRU de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France
CHU Grenoble
Verified postcode
Grenoble, France
Hospital de la Pitie-Salpetriere
Verified postcode
Paris, France
Hospital Europeen Georges-Pompidou (HEGP)
Verified postcode
Paris, France
Centre Cardiologique du Nord
Verified postcode
Saint-Denis, France
CHU de Saint-Etienne
Verified postcode
Saint-Priest-en-Jarez, France
Clinique Pasteur
Verified postcode
Toulouse, France
Vivantes Klinikum Am Urban
Verified postcode
Berlin, Germany
MVZ CCB Frankfurt und Main-Taunus GbR
Verified postcode
Frankfurt, Germany
Asklepios Klinik Saint Georg
Verified postcode
Hamburg, Germany
Henry Dunant Hospital Center
Verified postcode
Athens, Greece

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common heart condition where your heart beats irregularly, which can make you feel tired, dizzy, or short of breath.

What is Pulsed Field Ablation (FARAPULSE™)?

It's a new type of treatment for atrial fibrillation that uses controlled energy pulses to correct irregular heart rhythms, aiming to make your heart beat normally again.

Will I get special treatment in this study?

You will receive the FARAPULSE™ treatment as chosen by your doctor for your atrial fibrillation. The study collects information about this treatment as part of your standard care, rather than giving you extra treatments.

How long will I be followed for?

The study will collect information about your health and treatment for one year after your procedure.

Can I leave the study if I change my mind?

Yes, you can choose to stop being part of the study at any time. This will not affect the medical care you receive.