CompletedInterventional

The safety and efficacy of using shorter ablation times during pulmonary vein isolation using a multielectrode radiofrequency balloon catheter

Catheter ablation is a common treatment for atrial fibrillation (AF), an irregular heart rhythm condition. Doctors pass thin tubes into the heart and use heat to target the tissue causing the misfired electrical signals. However, the food pipe (oesophagus) sits directly behind the heart and can occasionally suffer heat injury during this process. This study tests a newer balloon catheter using radiofrequency heat for much shorter times—between 5 and 7 seconds instead of up to 20 seconds. The goal is to see if this quicker application is just as effective at treating AF while significantly lowering the risk of damage to the food pipe. Participants will receive the ablation with these reduced heat times. Within seven days after the procedure, patients will have a short camera check (an endoscopy) to look inside the food pipe and confirm it remains healthy.

At a glance

Status

Completed

Sponsor

University Hospitals Sussex NHS Foundation Trust

Enrolment target

120

Start

15 Dec 2023

Estimated completion

31 May 2024

Cardiovascular disease

What is this study about?

Atrial fibrillation (AF) is a common condition that causes an irregular and often very fast heartbeat. One of the main hospital treatments is catheter ablation, where doctors use heat energy to create tiny scars inside the heart. These scars block the faulty electrical signals causing the flutter. A balloon device using radiofrequency (heat) energy is often used to treat the area around the pulmonary veins, where these bad signals usually start.

The food pipe (oesophagus) lies right next to the back wall of the heart. During heat ablation, there is a very small but serious risk that heat can spread and injure the food pipe wall. Currently, doctors apply heat for up to 20 seconds in that area while keeping a close eye on the temperature to prevent harm.

Recent hospital data suggests that just 5 to 7 seconds of heat may be enough to successfully treat the heart tissue. This study is testing whether using these much shorter treatment times is safe and just as effective. If successful, it could make the procedure quicker and significantly reduce the chances of food pipe complications for future patients.

Key takeaways

Tests shorter heat times (5 to 7 seconds) during catheter ablation for atrial fibrillation.
Aims to protect the food pipe from heat damage while effectively treating the heart rhythm.
Requires a follow-up camera check (endoscopy) within seven days of the procedure.
Open to adults with AF who have not had previous heart surgery or ablations.
Participation is entirely voluntary and does not change your rights to standard NHS care.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with symptomatic atrial fibrillation (either coming and going, or continuous for less than one year) and are already considered suitable for a catheter ablation.

You cannot take part if you have had heart surgery in the past, have already had an ablation for atrial fibrillation, or have had continuous AF for more than a year. The study also excludes people who are pregnant, have a body mass index (BMI) over 40, have certain congenital heart problems, have a very enlarged heart chamber, or cannot safely take blood-thinning medicines.

Because safety checks are a key part of the research, you must also be able to tolerate a small temperature probe placed down your throat during the heart procedure, and you must be willing to have a camera check (endoscopy) of your food pipe within one week after the ablation.

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.

I am aged 18 or older.
I have been diagnosed with atrial fibrillation and my doctor recommends an ablation.
I have NOT had heart surgery or a previous heart ablation.
I have not had continuous atrial fibrillation for more than a year.
I can safely take blood-thinning medications.
I am willing to have a camera check of my food pipe within a week after my procedure.

Answer every question to see your result.

What does participation involve?

If you take part, you will have your planned catheter ablation using the shorter heat-delivery times. During the procedure under anaesthesia or sedation, doctors will place a small temperature probe into your food pipe to monitor safety. Within seven days of your heart procedure, you will attend a clinic visit to have an endoscopy—a quick test where a thin, flexible camera looks inside your food pipe to confirm there is no heat irritation. You will need to take your regular heart and blood-thinning medications as advised by your cardiology team. The research team will track your recovery and heart rhythm, with the overall study running until mid-2025 across participating UK centres.

Potential risks and benefits

Taking part may lower your chance of heat-related injury to your food pipe during your ablation. However, because the heat is applied for a shorter time, there is a possibility that the treatment might be less effective at keeping your heart in a normal rhythm. You will also experience the minor discomfort of a post-procedure endoscopy. The general risks of catheter ablation remain the same as standard NHS care. Joining the study is completely voluntary, and you can withdraw at any point without it affecting your medical care.

Locations (4)

Royal Sussex County Hospital
Approximate
Brighton, England
Walsgrave General Hospital
City only
Coventry, England
General Hospital of Athens Hippokration
City only
Athens, Greece
University Hospital Brussels
Approximate
Brussels, Belgium

Common questions

What is catheter ablation?

It is a routine procedure where doctors thread thin, flexible wires through a blood vessel into the heart to gently scar tiny areas of tissue causing abnormal rhythms.

Why can ablation affect the food pipe?

The food pipe runs directly behind the back wall of your heart, so heat used on that heart wall can occasionally warm the food pipe tissue nearby.

What is an endoscopy?

It is a short test where a doctor passes a thin, flexible tube with a camera down your throat to look at the lining of your food pipe.

Will taking part cost me anything?

No, the procedure and tests are covered as part of the research and your NHS care, though you may need to travel for your follow-up check.

What happens if I change my mind?

You can leave the study at any time without giving a reason, and your regular NHS care and treatment will continue as normal.

How to find out more

John Silberbauer

john.silberbauer@nhs.net +44 (0)1273 696955 Official trial record

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