RecruitingOBSERVATIONAL

Solutions to the Challenges of Conduction System Pacing

This study focuses on improving a new type of pacemaker called 'conduction system pacing'. Traditional pacemakers can sometimes cause the heart to beat a bit out of sync, which isn't ideal long-term. Conduction system pacemakers mimic the heart's natural electrical system more closely, creating a much more organised and healthier heartbeat. Currently, only a few experts can fit these special pacemakers. This research aims to make it easier to fit them in any hospital by finding the best spots in the heart for the wires and improving how the pacemaker understands the heart's electrical signals. Ultimately, this means more people could benefit from this advanced pacemaker technology for a healthier heart.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

300

Start

06 Nov 2023

Estimated completion

06 Nov 2026

Conduction System Pacing Pacing Therapy

What is this study about?

When your heart needs a pacemaker, the aim is to help it beat regularly and effectively. Traditional pacemakers do a good job, but they stimulate the heart muscle directly. Think of it like pushing a car by hand – it moves, but not as smoothly or efficiently as when the engine is running properly. This can sometimes lead to different parts of the heart beating slightly out of time, which isn't ideal over many years.

That's where 'conduction system pacemakers' come in. Instead of pushing the car, these pacemakers directly stimulate the heart's natural electrical wiring system, making the heart beat much more like it would on its own. This produces a more coordinated and natural heartbeat, which is better for your heart health in the long run. The problem is, these advanced pacemakers are difficult to fit and currently only a few specialist doctors can do it.

This study aims to change that. Researchers want to make it much simpler for any heart specialist in any hospital to fit these conduction system pacemakers. They plan to do this in two main ways: first, by carefully mapping the heart to find the best spots to place the tiny pacemaker wires, and figuring out how to guide doctors to these spots using standard X-rays. Second, they'll collect lots of information about the heart's electrical activity to develop better computer tools for the pacemaker, helping it to interpret these signals more accurately for the best possible heart rhythm.

Key takeaways

Aims to make advanced pacemakers more widely available.
Focuses on creating more natural heartbeats.
Involves extra measurements during pacemaker fitting.
Could improve future pacemaker technology for everyone.
Your medical care is not affected if you withdraw.

Who may be eligible?

This study is for adults generally aged between 18 and 100 years old who need a pacemaker. You might be suitable if you have certain heart conditions that cause very slow heartbeats or make your heart's electrical system out of sync. These conditions include specific types of 'heart block' or 'left bundle branch block'.

It's important that you are able to understand what the study involves and can give your consent to take part. Unfortunately, children under 18 or adults over 100 cannot join. Also, if you are pregnant, you won't be able to participate. For women of child-bearing age, a standard pregnancy test will be done before the procedure.

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 100 years old?
Do you need a pacemaker for specific heart conditions?
Are you able to understand and agree to participate?
Are you not pregnant (if applicable)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a conduction system pacemaker fitted, just like you would for normal care, but with some extra measurements conducted during the procedure. The first 50 patients will help the researchers find the best ways to place the wires and understand the heart's electrical signals. This involves additional tests, such as special ECG recordings, detailed electrical and anatomical mapping of your heart using small wires inserted from your groin, ultrasound scans of your heart, and precise blood pressure measurements. Some of these tests might involve wearing a special vest or having a pre-procedure CT scan.

These extra measurements will happen during your pacemaker insertion procedure and potentially some follow-up assessments. The full duration of your participation, including any follow-up appointments related to the study, will be discussed with you before you agree to take part.

Potential risks and benefits

Taking part in this study could potentially help develop better pacemaker treatments for future patients, offering a more natural heartbeat correction. For you, the pacemaker itself should improve your heart rhythm, as expected with any pacemaker. However, there are some extra procedures for this study, like additional scans or measurements during your pacemaker fitting. These carry small, known risks, similar to those associated with standard medical procedures and involve more time in hospital. The doctors and nurses looking after you will explain all procedures and their potential risks in detail. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Imperial College Healthcare Trust; Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'conduction system pacemaker'?

It's a newer type of pacemaker that stimulates your heart's natural electrical system directly, like an engine, for a more organised and healthier heartbeat.

Why is this study important?

It aims to make this advanced, more natural pacemaker available to more people in more hospitals by simplifying how it's fitted and improving its technology.

Will I get a pacemaker if I join this study?

Yes, if you're suitable for the study, you will have a conduction system pacemaker fitted as part of your care.

Will there be extra tests?

Yes, there will be some additional measurements and scans during your pacemaker fitting procedure to help the researchers gather information.

Can I leave the study if I change my mind?

Absolutely, you can withdraw from the study at any time without it affecting your medical treatment.

How to find out more

Akriti Naraen, MBChB

a.naraen@imperial.ac.uk +91203-31-31000 Official trial record

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