RecruitingNAINTERVENTIONAL

BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

This study is gathering information about a new treatment for an irregular heartbeat called atrial fibrillation (AF). The treatment uses a special balloon-based procedure called Pulsed Field Ablation (PFA) with the Volt PFA System. We want to see how well it works and how safe it is for people with different types of AF, including those whose AF comes and goes (paroxysmal) and those who have it continuously for longer periods (persistent). The study is collecting real-world experiences to understand the benefits and any potential downsides of this new technology. It also includes a smaller part of the study to answer specific questions doctors have about this kind of heart treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

300

Start

11 Dec 2025

Estimated completion

01 Aug 2027

Paroxysmal AF Atrial Arrhythmia Atrial Fibrillation Persistent Atrial Fibrillation

What is this study about?

This study is all about a new treatment for a common heart condition called atrial fibrillation, or AF. If you have AF, your heart beats irregularly, which can make you feel tired or dizzy. This new treatment is called Pulsed Field Ablation (PFA) and it uses a special balloon device called the Volt PFA System.

The main goal of this study is to collect information about how safe and effective this treatment is when used in everyday medical practice. We want to understand if it helps people whose AF comes and goes (called paroxysmal AF) or if it helps those who have AF continuously for longer periods (called persistent AF). We're trying to see how well it works for different people and in different situations.

By gathering this 'real-world' information, doctors can learn more about the best ways to use the Volt PFA System and if it's a good option for a wide range of patients. This helps to improve care for people living with atrial fibrillation.

Key takeaways

This study evaluates a new atrial fibrillation treatment called Pulsed Field Ablation (PFA).
It aims to understand the safety and effectiveness of the Volt PFA System in real-world patients.
Suitable for adults (18+) with paroxysmal or persistent AF.
Involves a heart procedure and follow-up medical checks.
Participation requires willingness to adhere to study visits and tests.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with either paroxysmal AF (your irregular heartbeat comes and goes) or persistent AF (your irregular heartbeat lasts longer than 7 days). Your doctor must have decided that you're going to have a new ablation procedure using the Volt PFA Catheter for your AF, especially if other medications haven't worked for you, or if you can't take them.

There are also some specific conditions that would prevent you from taking part. For example, if your irregular heartbeat is caused by other specific health issues like a thyroid problem or severe sleep apnea, or if you've had major surgery very recently. You also can't have any known blood clots in your heart or very weak heart pumping function (known as Left Ventricular Ejection Fraction less than 35%).

Lastly, you must be able and willing to follow all the study's instructions, including attending appointments and tests before, during, and after the procedure, and you must give your written permission to join after understanding what's involved.

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 at least 18 years old?
Do you have symptomatic atrial fibrillation (AF) that comes and goes, or lasts longer than 7 days?
Has your doctor planned for you to receive a new ablation procedure with the Volt PFA Catheter?
Have you tried AF medications that didn't work, or can't you take them?
Are you able and willing to attend all required appointments for the study?
Do you have a known blood clot in your heart or severe heart pumping problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be having a heart procedure using the Volt PFA Catheter as planned by your doctor. Before the procedure, you'll have some tests. After the procedure, the study team will ask you to attend follow-up appointments and have further tests to check how you're doing and how well the treatment worked.

These follow-up checks will continue for a certain period to make sure we understand the long-term effects of the treatment. You will need to commit to attending all these appointments and following the study instructions. The total duration of your participation will depend on the study's follow-up schedule, which the study team will explain in detail.

Potential risks and benefits

Participating in this study might offer you access to a new treatment using the Volt PFA System for your atrial fibrillation, which could potentially improve your heart rhythm and symptoms. However, like any medical procedure, there are potential risks involved with the ablation treatment itself. The study team will explain all known risks associated with the procedure. You will receive very careful monitoring throughout your participation. Remember, joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (22)

Ordensklinikum Linz Elisabethinen
Verified postcode
Linz, Austria· Recruiting
AZ Sint Jan
Verified postcode
Bruges, Belgium· Recruiting
UZ Brussel
Verified postcode
Brussels, Belgium· Recruiting
Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Hôpital Pitié Salpetrière
Verified postcode
Paris, France· Recruiting
Hopital Haut Leveque
Verified postcode
Pessac, France· Recruiting
Clinique Pasteur Toulouse
Verified postcode
Toulouse, France· Recruiting
Herz-und Diabetes Zentrum NRW
Verified postcode
Bad Oeynhausen, Germany· Recruiting
Medizinische Einrichtungen der Universität zu Köln
Verified postcode
Cologne, Germany· Recruiting
Asklepios Klinik St. Georg
Verified postcode
Hamburg, Germany· Recruiting
TUM Klinikum - Deutsches Herzzentrum München
Verified postcode
München, Germany· Recruiting
Mater Private Hospital
Verified postcode
Dublin, Ireland· Recruiting

Common questions

What is Pulsed Field Ablation (PFA)?

PFA is a new way to treat irregular heartbeats by using short bursts of electricity to create tiny scars that block the faulty electrical signals in your heart.

What is the Volt PFA System?

It's the specific equipment, including a special balloon catheter, used to deliver the Pulsed Field Ablation treatment during the procedure.

What's the difference between 'paroxysmal AF' and 'persistent AF'?

Paroxysmal AF means your irregular heartbeat comes and goes on its own, usually within a week. Persistent AF means it lasts longer than 7 days.

Will I have to pay to be in the study?

Clinical trials usually cover the costs of the treatment and tests related to the study. This will be fully explained before you agree to join.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Karolilen Timmermans

karolien.timmermans@abbott.com +3222006511 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.