Active not recruitingOBSERVATIONAL

Real World Data Collection in Subjects Treated With the FARAPULSE Pulsed Field Ablation System

This study is gathering real-world information about a new treatment for an irregular heartbeat condition called atrial fibrillation. The treatment, called FARAPULSE, uses a special energy to help the heart beat normally again. Boston Scientific developed this system, and this study aims to see how safe and effective it is when used in hospitals as part of their usual care. Researchers want to understand if it helps people feel better and improves their quality of life. About 1000 to 1500 people across Europe will take part. This is an observational study, meaning researchers will watch and collect information about what happens during and after the treatment without making changes to how doctors would normally treat you.

At a glance

Status

Active not recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

1,173

Start

24 Mar 2023

Estimated completion

15 Aug 2027

Atrial Fibrillation

What is this study about?

This study is gathering important information about a new treatment for a common heart condition called atrial fibrillation. Atrial fibrillation causes your heart to beat irregularly and sometimes very quickly, which can make you feel tired, breathless, or have a fluttering sensation in your chest. The main goal of treatments for atrial fibrillation is to get your heart back into a normal rhythm and reduce these uncomfortable symptoms.

The new treatment being looked at is the FARAPULSE System. This system uses a special type of energy, called 'pulsed field ablation,' to create tiny scars in specific areas of the heart that are causing the irregular heartbeat. These scars help to block the electrical signals that are making the heart beat out of rhythm, allowing it to return to a more regular beat. This study is designed to watch how well this treatment works and how safe it is when it's used in real-world hospital settings as part of a patient's normal care.

Researchers want to see if the FARAPULSE treatment helps people with atrial fibrillation improve their quality of life, meaning they feel better and can do more of the things they enjoy. This is an observational study, so doctors will be treating patients as they normally would, and researchers will simply collect information on their progress. This helps us understand how well new treatments work for a wide range of patients in everyday situations.

Key takeaways

It's about a new treatment called FARAPULSE for an irregular heartbeat (atrial fibrillation).
The study watches how well FARAPULSE works and how safe it is in real hospitals.
It's an 'observational' study, so you'll receive your normal medical care.
Researchers want to see if this treatment improves patients' quality of life.
About 1000-1500 adults will participate across Europe.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and your doctor must believe that the FARAPULSE treatment is the right choice for your atrial fibrillation, based on the hospital's usual care. You also need to be willing and able to understand what taking part in the study means and be able to attend any appointments or tests required.

There are certain situations that would prevent you from joining the study. For example, if you have certain existing heart conditions, such as a recent heart attack or stroke, or if you have a current infection. Patients who are pregnant or planning to become pregnant, or those with certain types of heart valve problems, would also not be able to take part. Doctors will also check if you have certain problems that might make an invasive heart procedure unsafe for you.

Quick self-check

Are you 18 years old or older?
Has your doctor suggested the FARAPULSE treatment for your atrial fibrillation?
Are you able and willing to attend follow-up appointments?
Do you have any serious underlying health conditions like a recent heart attack or stroke?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive the FARAPULSE treatment for your atrial fibrillation as decided by your doctor. The study itself is 'observational,' which means the researchers will be collecting information about your treatment and recovery, but they won't be asking you to take any extra medications or do anything outside of your usual medical care. You will have regular check-ups and follow-up appointments with your hospital and doctors, as you normally would for this type of procedure. During these appointments, information about your health, how the treatment is working, and how you are feeling will be collected. The study aims to gather this information over time, so it will involve collecting data during your treatment and at follow-up visits, as long as you remain a part of the study.

Potential risks and benefits

Participating in this study means that your treatment with the FARAPULSE system will be carefully observed, which helps us learn more about its safety and how well it works for patients in real-world situations. This information can ultimately help future patients with atrial fibrillation. While the FARAPULSE system is a treatment your doctor has recommended, like all medical procedures, there are always potential risks involved. Your doctor will discuss the specific risks of the ablation procedure with you. You have the right to withdraw from the study at any time, for any reason, without affecting the quality of your medical care.

Locations (48)

Prince Charles Hospital
Brisbane, Australia
Fiona Stanley Hospital
Murdoch, Australia
John Hunter Hospital
Newcastle, Australia
Allgemeines Krankenhaus AKH
Vienna, Austria
AZ Sint Jan Hospital
Bruges, Belgium
Hartcentrum Hasselt Jessa Ziekenhuis Campus Virga Jesse
Hasselt, Belgium
CHR de la Citadelle
Liège, Belgium
Neuron Medical in Brno
Brno, Czechia
Nemocnice Ceske Budejovice a.s.
České Budějovice, Czechia
Tays Heart Hospital
Tampere, Finland
CHU Grenoble
Grenoble, France
Hopital Saint Philibert-Hospital
Lomme, France

+36 more sites — see the official record for the full list.

Common questions

What is atrial fibrillation?

Atrial fibrillation is a condition where your heart beats irregularly and sometimes very fast, which can make you feel tired or dizzy.

What is the FARAPULSE treatment?

It's a new treatment that uses special energy to correct the irregular heartbeats in atrial fibrillation, helping your heart beat normally again.

Is this a new treatment, or is it already used?

The FARAPULSE system is a developed therapy, and this study is gathering more information on its safety and effectiveness when used in hospitals as part of standard care.

Will I have to do anything extra if I join the study?

No, this is an observational study. You'll receive your usual medical care, and researchers will collect information about your progress during your regular doctor visits.

How many people will be in this study?

Around 1000 to 1500 people will take part in this study across various hospitals in Europe.