RecruitingNAINTERVENTIONAL

Ablate and Pace HIS Study

This study is for people with a common heart rhythm problem called atrial fibrillation (AF), especially those who also show signs of heart failure. Sometimes, the usual treatments for AF don't work, or they're not suitable. In these cases, doctors might suggest a pacemaker alongside a procedure called AV node ablation to help control a fast heartbeat. Normally, a pacemaker lead is placed in the lower right chamber of the heart. This study is testing a newer method called His bundle pacing, where the pacemaker lead is placed in a different spot, aiming for a more natural way for the heart to beat. The goal is to see if this new method is safer, more effective, and better than the standard approach for these patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospitals, Leicester

Enrolment target

100

Start

24 Oct 2023

Estimated completion

29 Feb 2028

HIS Bundle Pacing Atrial Fibrillation

What is this study about?

This study is for people who have a common heart rhythm problem called atrial fibrillation (AF). With AF, the upper chambers of your heart beat irregularly and often too fast. Sometimes, this can lead to symptoms like feeling tired, breathless, or having a fluttering heart. If your symptoms are severe and other treatments, like medicines or a procedure called ablation, haven't worked or aren't suitable for you, your doctor might suggest a procedure to control your heart rate by blocking signals in your heart (called AV node ablation) and fitting a pacemaker.

Usually, when a pacemaker is fitted after AV node ablation, it's connected to the lower right chamber of your heart (this is called RV pacing). While this helps, sometimes it can make the lower left chamber of your heart weaker over time. This new study is looking at a different way to place the pacemaker lead, called His bundle pacing. This method tries to use your heart's natural electrical wiring more effectively, which might make your heart beat in a more natural way.

The main idea behind this study is to find out if His bundle pacing is a better option than the standard RV pacing for people with AF who also have signs of heart failure. Researchers want to see if it's safer, works better to improve heart function, and generally provides a more beneficial way for patients to live with their condition after a pacemaker is fitted.

Key takeaways

This study compares a new pacemaker fitting method (His bundle pacing) with the standard method.
It's for people with severe Atrial Fibrillation (AF) and signs of heart failure who need a pacemaker.
The goal is to see if the new method is safer and more effective for heart function.
Participation involves being randomly assigned to one of two pacemaker types and follow-up for 12 months.
The study takes place at one hospital in the UK.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. You might be suitable if you have atrial fibrillation (AF) that causes noticeable symptoms, such as feeling breathless or tired, and your doctors have decided that other treatments to bring your heart rhythm back to normal aren't the best option for you.

Crucially, you would be considered if you are already due to have a pacemaker fitted and a procedure called AV node ablation to help control a fast heart rate. This applies especially if you also show signs that your heart isn't pumping as strongly as it should, or if specific blood tests indicate potential heart strain.

You would not be able to join the study if you already have a pacemaker, if doctors have already decided you need a different type of complex pacemaker for severe heart weakness, if you are a woman who could become pregnant, or if you have another serious illness that means you're not expected to live for more than a year. Also, if you're unable to understand and agree to take part, or simply don't wish to, you won't be included.

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?
Do you have AF that causes symptoms and other treatments haven't worked?
Are you scheduled for a pacemaker and AV node ablation?
Do you have signs of your heart not pumping as strongly as it should?
Do you NOT already have a pacemaker?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly chosen to receive either the standard pacemaker fitting (called RV pacing) or the newer His bundle pacing. Both types of pacemakers will be fitted. If you're chosen for His bundle pacing, an extra lead will be placed, and the standard lead will only be used as a backup if needed. You will also have a procedure called AV node ablation to help with your heart rate, either at the same time as your pacemaker fitting or a few weeks later.

Neither you nor the healthcare staff checking your progress will know which pacing method you're receiving at first. You will have check-ups at the start of the study, then again at 4 weeks, 6 months, and 12 months after you join. During these visits, the study team will carry out various tests to see how your heart is doing. You'll find out which pacing method you received at your final 12-month visit. The entire study will last for 12 months.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as receiving specialised care and access to a newer pacing technique that might improve your heart function more effectively than standard care. However, as with any medical procedure, there are potential risks associated with pacemaker implantation and AV node ablation, such as infection, bleeding, or issues with the lead placement. The study aims to find out if the new method is superior, meaning it could offer better outcomes, but this is not guaranteed for any individual. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

University Hospitals of Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is Atrial Fibrillation (AF)?

AF is an irregular and often very fast heartbeat. It can cause problems like tiredness, dizziness, and shortness of breath.

What is a pacemaker?

A pacemaker is a small device placed under your skin, usually near your collarbone. It uses electrical pulses to help your heart beat regularly.

What is His bundle pacing?

His bundle pacing is a newer way to place a pacemaker lead that aims to use your heart's natural electrical system to create a more efficient and natural heartbeat.

Will I know which type of pacing I'm getting?

Initially, neither you nor the doctors assessing your progress will know. You will be told which method you received after 12 months.

Who is funding this study?

The study is receiving funding from Medtronic, a medical technology company, and the main sponsor is University Hospitals of Leicester.

How to find out more

Mokhtar Ibrahim, Dr

mokhtar.ibrahim@uhl-tr.nhs.uk 0116 2583887 Official trial record

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