RecruitingNAINTERVENTIONAL

Rate or Rhythm Control in CRT: the RHYTHMIC Study

This study, called RHYTHMIC, investigates the best way to manage an irregular heart rhythm (Atrial Fibrillation, or AF) in people who also have heart failure and a special pacemaker called a CRT device. Some people with these devices still have a fast, irregular heartbeat. The study will compare two procedures: AF catheter ablation, which aims to restore a normal heart rhythm, and AV node ablation, which aims to slow down the heart rate. By comparing these two approaches, researchers hope to understand which method works better to improve heart function and quality of life for these patients. The results will help doctors make better treatment decisions in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

19 Oct 2021

Estimated completion

30 Sep 2027

Atrial Fibrillation Heart Failure

What is this study about?

If you have heart failure and an irregular heart rhythm called Atrial Fibrillation (AF), you might have a special type of pacemaker called a CRT device. Sometimes, despite having this device, your heart can still beat irregularly, which can make your heart failure symptoms worse. This study, called RHYTHMIC, is looking at two different ways to help control this irregular rhythm. One option is called AF catheter ablation. This procedure uses heat or cold to create tiny scars in your heart tissue, which helps block the faulty electrical signals causing the AF, ideally restoring a normal, steady heart rhythm. The other option is called AV node ablation. This procedure involves carefully damaging a small area of heart tissue (the AV node) that controls the electrical signals going from the top to the bottom chambers of your heart. When this is done, a regular pacemaker becomes essential to control your heart rate, as the AV node can no longer do this. This typically results in a slower, more controlled heart beat, though it might not restore a normal rhythm.

The study aims to see which of these two approaches is more effective in improving how well your heart works and your overall well-being. Researchers will carefully monitor participants for six months after their procedure, using heart scans and other tests to check on their progress. By comparing the results, doctors hope to gain important insights into which treatment strategy is most beneficial for people living with both heart failure and AF.

They will also be doing some special tests during the ablation procedure to understand more about how these treatments affect the heart's pumping action. This includes measuring pressures inside the heart, which provides new information that could help develop even better treatments in the future. There’s also an optional extra part where doctors can create detailed maps of your heart’s electrical activity during the procedure, which helps them understand the AF even better.

Key takeaways

This study compares two treatments for irregular heartbeats (AF ablation VS AV node ablation) in people with heart failure.
It aims to find out which treatment is better for improving heart function and quality of life.
Participants will have detailed heart health checks and a specific ablation procedure.
There are additional research tests during the procedure to learn more about the heart.
Your active involvement in the study will last for about six months.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to take part in this study, you need to be an adult between 18 and 85 years old. You should have heart failure and an irregular heart rhythm called Atrial Fibrillation (AF). You'd also need to have previously received a special type of pacemaker called a CRT device, but still experience a fast or irregular heartbeat due to AF, meaning your heart's lower chambers aren't being paced efficiently enough.

Your doctor would also need to have already decided that one of the procedures being studied (AV node ablation) is a suitable treatment option for you based on current medical guidelines. You'll also need to be able to understand and agree to participate in the study and commit to attending all the follow-up appointments.

There are also some reasons why you wouldn't be able to join. These include if you have a very short life expectancy (less than one year), have blood clots in your heart, or if your Atrial Fibrillation is considered permanent and not expected to change. If you have a mechanical aortic valve, severe problems with blood flow in your legs, are pregnant, breastfeeding, or planning to become pregnant, you also won't be able to participate. Lastly, if you're already receiving active treatment in another research study, this study might not be 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 between 18 and 85 years old?
Do you have heart failure and an irregular heart rhythm (Atrial Fibrillation)?
Do you have a special pacemaker called a CRT device, but your heart still beats irregularly due to AF?
Has your doctor suggested AV node ablation as a possible treatment for you?
Are you able and willing to attend follow-up appointments for about six months?
Are you not pregnant, breastfeeding, or planning a pregnancy during this time?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you'll first have some initial health checks, including a heart scan, blood tests, and tests to see how well you can exercise. You’ll also fill out a questionnaire about your quality of life with heart failure. Once these checks are done and if you're suitable, you’ll be randomly assigned to receive one of two procedures: either AF catheter ablation or AV node ablation. This is like flipping a coin – neither you nor the doctors decide which procedure you get.

During your ablation procedure, whether it's for AF or the AV node, doctors will also perform some extra research tests. This includes placing small wires into your heart through a vein in your groin and an artery in your wrist or groin to measure pressures. There's also an optional additional test where doctors can create detailed electrical maps of your heart. After your procedure, you'll have follow-up visits and assessments after six months, which will include another heart scan and other tests to see how you're doing. The total duration of your active participation will be about six months.

Potential risks and benefits

Taking part in this study may offer potential benefits for your heart health by helping to manage your irregular heartbeat and potentially improve your heart function and quality of life. However, like any medical procedure, both types of ablation carry potential risks, such as bleeding, infection, and very rarely, more serious complications. The additional research tests during the procedure, like pressure measurements and optional heart mapping, also have small, associated risks, which your doctor will discuss with you. You will be fully informed of all potential risks and benefits before deciding to participate, and remember, you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

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

Guys and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Atrial Fibrillation (AF)?

AF is a common type of irregular heartbeat that can make your heart beat too fast, too slow, or unevenly. It can cause symptoms like tiredness, breathlessness, and dizziness.

What is a CRT device?

A CRT device is a special pacemaker for people with heart failure. It helps the two main pumping chambers of your heart beat in sync, which can improve heart function.

What's the difference between AF ablation and AV node ablation?

AF ablation tries to correct the irregular rhythm to a normal one, while AV node ablation aims to slow down the heart rate, usually meaning you'll rely on a pacemaker for rhythm control.

Will I know which treatment I'm getting?

Yes, once you're assigned to a group, your doctors will tell you whether you'll be having AF ablation or AV node ablation.

Can I stop participating in the study if I change my mind?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Christopher A Rinaldi

aldo.rinaldi@kcl.ac.uk 02071889257 Official trial record

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