Comparing Three Types of Specialist Pacemakers to Improve Heart Function and Reduce Rhythm Problems in Heart Failure
This research is looking into three different types of special pacemakers, called cardiac resynchronisation therapy (CRT) devices, for people living with heart failure. We specifically want to find out which type is most effective at making your heart work better and reducing irregular heartbeats when there's a delay in how the main pumping chambers of the heart beat together. You'd be randomly assigned one of the three pacemaker types, including the current standard treatment. The study will track your symptoms and heart health over six months, with a few hospital visits and some specific tests to understand how these pacemakers help your heart.
At a glance
What is this study about?
If you have heart failure, your heart struggles to pump blood around your body effectively. Sometimes, this happens because the lower chambers of your heart, called ventricles, don't beat at the same time, which is like an out-of-sync rhythm. Special pacemakers, known as CRT devices, are designed to help these chambers beat together more efficiently, improving how your heart pumps.
This study aims to discover which of three different pacemaker approaches works best. One is the 'conventional biventricular pacing' (BVP), which is the standard treatment offered currently. The other two, 'conduction system pacing' (CSP) and 'left bundle optimised CRT' (LOT-CRT), are newer ways of pacing the heart that researchers hope might be even more effective. By comparing them, we hope to find better ways to help people with heart failure feel better and reduce heart rhythm issues.
The researchers will be looking closely at how these different pacemakers affect your heart over a six-month period. They'll monitor your symptoms, check the strength of your heart muscle, and see how the electrical signals in your heart respond. This will help them understand which method provides the most benefit for people living with heart failure.
Key takeaways
- This study compares three types of pacemakers for people with heart failure.
- It aims to find the most effective pacemaker to improve heart function.
- You'll have one of three pacemakers, chosen at random.
- Participation involves 4 hospital visits and symptom tracking over 6 months.
- Special tests will help researchers understand your heart's electrical activity.
Who may be eligible?
This study is looking for adults aged 18 or over who are already scheduled to receive a CRT pacemaker, either for the first time or as an upgrade to an existing one. You would need to have heart failure symptoms, and your doctor would have confirmed that your heart isn't pumping blood as strongly as it should (this is called reduced ejection fraction). Also, specific measurements of your heart's electrical activity (seen on an ECG) need to show certain patterns, indicating that your heart's chambers aren't beating in perfect time.
It's important that you are already receiving the best possible medication for your heart failure. If you are unable to understand and agree to take part in the study, or if you are pregnant, you won't be able to join. For women who could become pregnant, a pregnancy test would be needed.
- Are you 18 years old or older?
- Are you scheduled to get a special pacemaker (CRT) for heart failure?
- Do you have symptoms of heart failure and a weakened heart pump?
- Do your heart's electrical tests (ECG) show specific timing issues?
- Are you already on the best possible medication for your heart failure?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you would have four hospital visits over a six-month period. Your first visit is to learn more about the study, answer any questions, and have some checks to make sure you're suitable. You'll also get help setting up a smartphone app to track your symptoms daily.
At the second visit, you'll have your CRT pacemaker implanted. This will be chosen randomly, meaning there's a one-in-three chance you'll receive the standard treatment (BVP), or one of the newer methods (CSP or LOT-CRT). You won't be able to choose which type you get. During this visit and your final visit (six months after the implant), you'll have some special tests. These involve wearing a vest and having a brief, low-dose CT scan, which helps researchers understand your heart's electrical activity. Your third and fourth visits will be routine check-ups for your pacemaker and heart health.
Potential risks and benefits
Locations (1)
- Hammersmith Hospital, Imperial College Healthcare NHS TrustLondon, United Kingdom· Recruiting
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should, leading to symptoms like tiredness or breathlessness.
What is a pacemaker?
A pacemaker is a small device placed under your skin in your chest that sends electrical signals to your heart to help it beat regularly.
What does 'randomly chosen' mean?
It means the type of pacemaker you receive will be decided by chance, like flipping a coin, so it's fair for scientific comparison.
Will I know which pacemaker I have?
Yes, your medical team will inform you which type of pacemaker you have received.
How long will I be in the study?
You'll be involved in the study for about six months in total, including the pacemaker implantation and follow-up visits.
How to find out more
Jack W Samways, MBChB, MRes, MRCP
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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