RecruitingInterventional

A study testing two treatments for a type of irregular heartbeat (paroxysmal atrial fibrillation): one using standard vein isolation, and the other combining that with a new technique that targets nerve clusters on the heart using pulsed energy

This study is testing two ways to treat a common irregular heartbeat called paroxysmal atrial fibrillation (AF), where your heart beats out of rhythm for a short time and then returns to normal. Both treatments use a method called Pulsed Field Ablation (PFA), which works from inside the heart to correct the irregular beats. One group will get the standard PFA treatment. The other group will get PFA inside the heart plus a new technique that targets specific nerve clusters on the outside of the heart using pulsed energy. Researchers want to see if combining these treatments leads to more effective and longer-lasting results for patients with AF. The study is open to adults aged 18-80 who have paroxysmal AF.

At a glance

Status

Recruiting

Sponsor

University Hospitals Sussex NHS Foundation Trust

Enrolment target

Start

01 Oct 2025

Estimated completion

01 Oct 2026

Atrial fibrillation treatment using new pulsed field ablation

What is this study about?

This study is called a clinical trial, and it's designed to investigate a new way to treat a common heart condition called paroxysmal atrial fibrillation (AF). AF causes your heart to beat irregularly, often feeling like a flutter or a racing pulse. 'Paroxysmal' means these irregular beats come and go, stopping on their own.

The main treatment method being studied is called Pulsed Field Ablation (PFA). This is a modern technique used by heart specialists to correct irregular heartbeats. It involves using special energy from inside your heart to create tiny scars that block the faulty electrical signals causing AF. PFA is generally safer than older methods, especially regarding avoiding damage to nearby organs like the food pipe (oesophagus) or the nerve that helps you breathe (phrenic nerve).

However, heart specialists wonder if PFA, which operates from inside the heart, might not affect certain nerve clusters on the heart's outer surface that can also trigger AF episodes. So, this study wants to find out if adding a new step – gently treating these outer nerve clusters with pulsed energy – will make the AF treatment even more effective and help keep your heart rhythm regular for longer. It's hoped this combined approach could lead to better outcomes for people with this type of AF.

Key takeaways

Tests two types of treatment for irregular heartbeats (AF).
Both use a new, safer method called Pulsed Field Ablation (PFA).
One group gets PFA; the other gets PFA plus an extra nerve treatment.
Aims to find out which approach works best for longer.
Open to adults aged 18-80 with paroxysmal AF.
You won't know which treatment group you are in.

Who may be eligible?

To be part of this study, you need to be an adult between 18 and 80 years old and have paroxysmal atrial fibrillation, which means your irregular heartbeats come and go on their own. Your doctor will also need to have decided that you are suitable for a heart ablation procedure.

There are also some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or planning to become pregnant during the study. You also can't be in another clinical study at the same time. If you have significant heart problems other than your AF, or if your BMI (body mass index) is over 40, you might not be eligible. Also, if you can't use a smartphone app for monitoring, or have certain allergies, you might not be able to take part.

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 between 18 and 80 years old?
Do you have paroxysmal atrial fibrillation (AF that comes and goes)?
Have your doctors said you are suitable for an ablation procedure?
Are you able to use a smartphone application for monitoring?
Are you not currently pregnant, breastfeeding, or planning a pregnancy?
Are you not currently in another clinical trial?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups, like flipping a coin. You won't know which group you're in, and neither will your doctors. One group will receive the standard PFA treatment inside the heart. The other group will receive the PFA treatment inside the heart, plus the new technique targeting nerve clusters on the outside of the heart.

All procedures will be done under general anaesthesia (you'll be asleep) by expert heart specialists at the Royal Sussex County Hospital in Brighton. To keep an eye on your heart rhythm, a small heart monitor will be placed under your skin. You'll also have a 24-hour ECG two months after your procedure to check your nerve function. The study is expected to run from June 2025 until October 2027.

Potential risks and benefits

There are potential benefits to taking part in this study. The PFA treatment, in general, is thought to have safety benefits compared to older methods, with a lower risk of damage to your food pipe or breathing nerve. For the group receiving the combined treatment, there's a chance it could lead to more stable and long-lasting regular heart rhythms. Previous smaller studies have shown promising results for targeting these nerve clusters, with a higher number of patients staying free from AF. However, like any medical procedure, there are also risks. For any AF ablation, there's a very small risk of death (about 1 in 1000 people). There's a risk of temporary inflammation and pain around the heart (called pericarditis, affecting 1 to 2 out of 100 people), and a small risk of infection (1 in 100 people). For those having the extra procedure on the outside of the heart, there are additional, though still small, risks. These include bleeding around the heart, a small air leak near the lung, or injury to the liver. Often, these don't need treatment, but sometimes a small drain might be needed. The general anaesthetic itself carries minimal additional risk. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

University Hospitals Sussex NHS Foundation Trust
City only
Worthing, United Kingdom

Common questions

What is paroxysmal atrial fibrillation?

It's a type of irregular heartbeat where episodes come and go on their own, usually lasting less than 7 days.

What is Pulsed Field Ablation (PFA)?

It's a modern heart treatment that uses special energy to create small scars inside the heart to correct irregular rhythms like AF.

Will I know which treatment I'm getting?

No, you'll be randomly assigned to one of two groups, and neither you nor your doctors will know which treatment you are receiving.

Where will the procedure take place?

All procedures will be carried out at the Royal Sussex County Hospital in Brighton.

How long will the study last for me?

The study itself runs from June 2025 to October 2027, but your individual participation will involve the procedure, follow-up monitoring, and assessments during that period.

How to find out more

Ian Mann

ian.mann2@nhs.net +44 (0)7779224567 Official trial record

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