RecruitingOBSERVATIONAL

AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry

This study is about a new type of heart pacemaker called AVEIR™. Unlike traditional pacemakers, this one is much smaller and doesn't need connecting wires. It's designed for people who have slow heartbeats (bradycardia) or conditions like heart block, which can cause fainting. The study will follow 600 patients across the UK for five years after they receive the AVEIR™ pacemaker. The main goal is to check how safe and effective the device is over a long time. It will also help doctors understand more about the people who receive this new pacemaker within the NHS. All information collected will be anonymous.

At a glance

Status

Recruiting

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

300

Start

15 Apr 2025

Estimated completion

01 Sep 2032

Bradycardia Atrio-Ventricular Block Syncope

What is this study about?

Imagine you have a heart condition that sometimes makes your heartbeat too slowly, which can make you feel dizzy or even faint. Doctors often use a device called a pacemaker to help keep your heart beating at a healthy rhythm. Over the years, pacemakers have gotten smaller and smarter.

This study is about a new, very small pacemaker called AVEIR™. What's special about it is that it's 'leadless,' meaning it doesn't need wires (leads) to connect it to your heart, and it's placed directly inside your heart. This is different from older pacemakers which sit under your skin near your collarbone with wires going to your heart. The AVEIR™ pacemaker was approved for use in Europe in 2023.

Doctors want to understand how well this new AVEIR™ pacemaker works and how safe it is for patients in the UK over a long time. They will follow 600 patients for five years after they get the pacemaker. This isn't a test where you get a new treatment; it's about watching how the pacemaker performs in real-world situations, as part of your normal care in the NHS. The study will also help them learn more about the types of patients who receive this new device and if there are any issues with it. All the information collected will be kept private and anonymous.

Key takeaways

New pacemaker study: Focuses on the AVEIR™ leadless pacemaker.
Long-term look: Tracks how the pacemaker performs over five years.
No wires: This pacemaker is small and placed directly in the heart.
Real-world data: Information gathered during normal NHS care.
Safety and effectiveness: Aims to confirm the device's long-term safety and how well it works.
Anonymous data: Your personal details will be kept private.

Who may be eligible?

To join this study, you would need to be someone who is either going to get, or has just received, the AVEIR™ leadless pacemaker. Your heart doctor must agree that this type of pacemaker is suitable for you.

You also need to be willing to come to all the necessary follow-up appointments and tests outlined by the study. Before you can join, you'll be given all the information about the study, and if you agree, you'll sign a form to say you understand and are happy to take part. This form will have been approved by an ethics committee to ensure your safety and rights are protected.

You wouldn't be able to join if your heart doctor doesn't think the leadless pacemaker is right for you, or if you're not able or willing to attend the required follow-up visits or sign the consent form.

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.

Am I planned to receive, or have I recently received, an AVEIR™ leadless pacemaker?
Does my heart specialist think this type of pacemaker is right for me?
Am I willing to attend all my regular check-up appointments for five years?
Am I willing to sign a consent form after learning about the study?
Am I happy for my anonymous health information to be collected for the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the AVEIR™ leadless pacemaker as part of your standard care. After the pacemaker is put in, doctors will follow your health for five years. During this time, you will have regular check-ups, just like any other patient with a pacemaker. These visits will be part of your usual care within the NHS. At these appointments, the study team will gather details like your age, sex, and medical history. They will also note why you needed the AVEIR™ pacemaker and if you experience any problems related to the procedure or the device. All your personal details will be kept anonymous. You won't have any extra visits that are different from what someone would normally have with this type of pacemaker.

Potential risks and benefits

Taking part means you'll be getting a new type of pacemaker that might offer benefits like being smaller and not needing wires. While the AVEIR™ pacemaker is approved for use, just like any medical procedure, there can be potential risks associated with its insertion or how it works over time. The study aims to gather more information on these long-term safety and performance aspects. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (2)

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

Royal Brompton Hospital
Verified postcode
London, United Kingdom· Recruiting
The Royal Brompton Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is a 'leadless' pacemaker?

A leadless pacemaker is a very small device that is put directly inside your heart, unlike traditional pacemakers which sit under your skin and connect to your heart with wires (leads).

Why is this study being done?

The study aims to understand how well the new AVEIR™ leadless pacemaker works and how safe it is for people in the UK over a long period (five years) in real-life NHS care.

Will I get any special treatment if I join?

No, you will receive the pacemaker and follow-up care as part of your normal NHS treatment. The study just collects information about how the device performs.

Is my personal information safe?

Yes, all the information collected about you for the study will be kept anonymous to protect your privacy.

How long will I be involved in the study?

You will be followed by the study for five years after you receive the AVEIR™ leadless pacemaker.

How to find out more

Ines Kralj-Hans, PhD

i.kralj-hans@rbht.nhs.uk 0330128 8854 Official trial record

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