RecruitingOBSERVATIONAL

Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.

This study looks at two newer types of pacemakers: one that doesn't need wires (leadless) and another that works with your heart's natural electrical system (left bundle branch pacing). Standard pacemakers, which use wires inserted through a heart valve, can sometimes lead to valve issues or weaken the heart over time. Researchers want to understand how these newer, potentially safer pacemakers affect your heart's pumping ability and a specific valve called the tricuspid valve. By comparing them directly during a routine pacemaker procedure, they hope to learn which type is better for different patients, particularly those who might be more prone to heart or valve problems.

At a glance

Status

Recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

18 Aug 2026

Estimated completion

01 Jun 2029

Pacemaker-Induced Cardiomyopathy Tricuspid Regurgitation Right Ventricular Dysfunction

What is this study about?

When people need a pacemaker, it's usually because their heart's natural electrical system isn't working properly, causing their heart to beat too slowly or irregularly. The traditional way to put in a pacemaker involves placing a small wire, called a lead, through one of the heart's valves, into the lower right chamber.

While effective, this method can sometimes cause problems. The wire passing through the valve might affect how the valve works over time, or the way the pacemaker stimulates the heart might slightly weaken its pumping ability. Scientists are always looking for better ways to do things, and new types of pacemakers have been developed to try and avoid these issues.

This study is looking at two of these newer types: one called a 'leadless pacemaker,' which is a tiny device placed directly inside the heart without any wires, and another called 'left bundle branch area pacing.' This second type tries to mimic the heart's natural electrical signals more closely. The main goal of this research is to see how these new pacemakers affect your heart's strength and how a specific valve, the tricuspid valve, works. By comparing them directly, doctors hope to understand which option is best for different patients, especially those who are at higher risk of heart or valve complications.

Key takeaways

Compares two new pacemaker types: leadless and left bundle branch.
Aims to understand their effects on heart function and heart valves.
Study procedures are done during your planned pacemaker surgery.
Helps doctors choose the best pacemaker for future patients.
You must be having a pacemaker fitted at Guy's and St Thomas' to take part.

Who may be eligible?

To be able to join this study, you would need to be at least 18 years old and already scheduled to have a permanent pacemaker fitted at Guy's and St Thomas' NHS Foundation Trust in the UK. This is typically for conditions where your heart beats too slowly or irregularly, such as a severe type of heart block.

There are certain reasons why you wouldn't be able to take part. For example, if your heart's main pumping chamber is already weak, or if you have severe problems with your tricuspid valve, or if you've had certain heart surgeries in the past. Also, if you're pregnant, have a very short life expectancy, or have kidney problems, you wouldn't be eligible.

Your doctor will check other specific health conditions, such as severe leg artery disease or if you can't have certain scans, to make sure this study is safe and suitable for you.

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 scheduled for a permanent pacemaker at Guy's and St Thomas' Hospital for slow or irregular heartbeat?
Is your main heart pumping chamber (left ventricle) currently working well (not weak)?
Do you *not* have severe problems with your tricuspid heart valve?
Are you *not* pregnant?
Have you *not* had certain major heart surgeries (like a new tricuspid or aortic valve)?

Answer every question to see your result.

What does participation involve?

If you agree to take part, you will have the study procedures at the same time as your routine pacemaker implantation. This means everything happens during one visit, while you are already under general anaesthetic for your planned surgery. There are no extra hospital visits required for the study itself.

During this single session, the doctors will briefly test both types of new pacemakers (leadless and left bundle branch pacing) to see their immediate effects on your heart and its valves, before fitting your permanent pacemaker as planned. This involves various assessments, but all are done while you're asleep. After your pacemaker is fitted, your care will continue as normal according to your doctor's plan, and there are no additional follow-up appointments directly related to this study.

Potential risks and benefits

Taking part in this study could help doctors understand more about which pacemaker is best for different people, potentially leading to better outcomes for future patients. For you, the main benefit is contributing to important medical knowledge. As all tests are done during your planned pacemaker surgery, there are no extra operations or hospital stays. However, as with any medical procedure, there are potential risks, though these are considered minimal as they happen during an already planned surgery. You have the right to change your mind and withdraw from the study at any time, without affecting your medical care.

Locations (1)

St. Thomas' Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a pacemaker?

A pacemaker is a small device placed in your chest that sends electrical pulses to help your heart beat at a normal rhythm.

What are 'leadless' pacemakers?

These are very small pacemakers placed directly inside the heart, so they don't need any wires (leads) like traditional pacemakers.

What is 'left bundle branch area pacing'?

This is a new technique where the pacemaker wire is placed to stimulate the heart's natural electrical system more directly, aiming for a more natural heartbeat.

Will I get an extra operation?

No, all study tests happen during your single, planned pacemaker implantation procedure while you are under anaesthetic.

Will this study affect my pacemaker choice?

The study aims to understand these devices. Your doctor will still choose the best permanent pacemaker for you based on standard medical practice.

How to find out more

Aldo Rinaldi, MD

aldo.rinaldi@kcl.ac.uk +44207 188 9275 Official trial record

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