RecruitingNAINTERVENTIONAL

REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY

This study is gathering information on a new treatment for a common irregular heartbeat condition called atrial fibrillation (AF). This condition can cause your heart to beat too fast or unevenly, making you feel unwell. The new treatment uses a special catheter (a thin, flexible tube) with a balloon and a basket-like tip to deliver a type of energy called Pulsed Field Ablation (PFA). This energy helps to correct the heart's electrical signals. The study, called REVOLUTIONARY Registry, is looking at how this new treatment works in real-world settings in hospitals across Europe. It wants to see how well it helps patients, how safe it is, and how easily doctors can learn to use it. This will help doctors understand the best way to use this new technology to help people with AF.

At a glance

Status

Recruiting

Phase

Sponsor

Cardioangiologisches Centrum Bethanien

Enrolment target

1,000

Start

07 Oct 2025

Estimated completion

07 Oct 2027

Treatment of Atrial Fibrilation Symptomatic Atrial Fibrillation

What is this study about?

This study is called the REVOLUTIONARY Registry, and it's all about understanding how a new treatment for an irregular heartbeat condition, called atrial fibrillation (AF), works in everyday medical practice. Atrial fibrillation is when the top chambers of your heart beat in a disorganised way, which can make you feel tired, dizzy, or short of breath. Finding effective ways to treat AF is really important for improving people's quality of life.

The new treatment being looked at uses something called Pulsed Field Ablation, or PFA. Imagine a special, very thin tube (a catheter) with a small balloon and a basket-like tip at the end. This catheter is gently guided into the heart. Once there, it delivers short bursts of electrical energy to tiny areas of the heart that are causing the irregular rhythm. The goal is to create controlled scars that block the faulty electrical signals, helping your heart beat normally again.

This study isn't a traditional trial where people get a new treatment versus an older one. Instead, it's a 'registry'. This means doctors are collecting information from patients who are already receiving this new PFA treatment in regular hospitals. They want to see how well it works for different people, whether it's safe, and how easy it is for doctors to learn and use the new device. By gathering this real-world information, they hope to get a better understanding of the benefits and challenges of this exciting new technology for treating AF.

Key takeaways

This study looks at a new treatment for irregular heartbeats (AF).
It uses a special device to correct the heart's rhythm with electrical energy.
Data is collected from patients already having this treatment in hospitals.
The goal is to understand how well the new treatment works and its safety.
Participation means your medical information from your treatment is used for research.
It helps doctors learn the best ways to use this new technology for AF.

Who may be eligible?

To be included in this study, you would be an adult, aged 18 or older, and have already decided with your doctor to have a procedure for your atrial fibrillation using this new PFA system. You also need to be able to understand what the study involves and agree to take part.

There are also some reasons why you might not be able to join. For example, if parts of your heart are very enlarged, or if you have certain severe heart valve problems, or if there's any blood clot found inside your heart. Also, if you have other medical issues that your doctor thinks make AF ablation unsuitable for you, you wouldn't be able to participate.

Pregnant or breastfeeding women, or women who could become pregnant and are not using effective contraception, would also not be able to join. The study also excludes people with untreated thyroid problems, active infections, or if you cannot take blood-thinning medication.

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?
Are you already scheduled to have an AF ablation using the VOLT PFA system?
Do you not have severe heart valve problems or a very enlarged heart chamber?
Are you not pregnant, breastfeeding, or planning a pregnancy without contraception?
Do you not have an active infection or untreated thyroid issues?

Answer every question to see your result.

What does participation involve?

This study is a 'registry,' which means if you're already having the new PFA ablation procedure for your atrial fibrillation using the specific VOLT device, your doctors will collect information about your treatment. You won't be asked to do anything extra or have additional visits purely for the study. The doctors will note down details about your heart condition before the procedure, how the procedure itself goes, and how you're doing afterwards. This follow-up information would typically be collected during your standard check-ups with your doctor, so there are no extra appointments you'd need to attend. The total duration of data collection will depend on the standard follow-up schedule your doctor recommends.

Potential risks and benefits

Taking part in this study means doctors collect information about your treatment, but you won't get any different care than you would otherwise. The potential benefit is that the information gathered will help doctors and other patients in the future by improving our understanding of this new treatment for atrial fibrillation. As this study collects data from procedures you are already undergoing, the risks associated are those of the standard PFA ablation procedure itself, which your doctor will explain to you. You are always free to decide not to have your data included in the registry at any time without it affecting your medical care.

Locations (1)

Mvz Ccb Am Agaplesion Markus Krankenhaus
Verified postcode
Frankfurt, Germany· Recruiting

Common questions

What is atrial fibrillation (AF)?

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

What is Pulsed Field Ablation (PFA)?

PFA is a new way to treat AF using short bursts of electrical energy to create tiny scars in your heart, helping it beat normally again.

Is this study a clinical trial?

This is a 'registry' study, meaning doctors are collecting information on patients already having the PFA treatment in their regular care, not testing a new drug or procedure against another.

Will I have extra doctor visits if I join?

No, your information for this study will be collected during your routine medical appointments and check-ups for your AF treatment.

What is the VOLT device?

The VOLT device is the specific balloon-in-basket catheter used to deliver the Pulsed Field Ablation energy in this new treatment.

How to find out more

Boris Schmidt, Prof.Dr.med.

b.schmidt@ccb.de 004906909450280 Official trial record

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