Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillation (AF), Heart Failure and Preserved Ejection Fraction: Heart Rate Regularization Versus Medical Rate Control
This study aims to understand if a combination of therapies works better than standard medication for people who have both permanent atrial fibrillation and a specific type of heart failure known as heart failure with preserved ejection fraction (HFpEF). Researchers are comparing a procedure called AV node ablation, which uses heat to create a block in the heart's electrical system, combined with a pacemaker, against current drug treatments. The main goal is to see if this new approach can help reduce serious problems like death or hospital stays due to heart failure. We know that irregular heartbeats can be hard on the heart, and this study tries to find out if making the heart rate more regular with a pacemaker and ablation can improve health for these patients.
At a glance
What is this study about?
This study is for people who have two heart conditions: permanent atrial fibrillation and a type of heart failure called heart failure with preserved ejection fraction (often shortened to HFpEF). Atrial fibrillation means your heart beats irregularly and often too fast. HFpEF means your heart muscle still pumps blood out strongly, but it has become stiff and doesn’t relax properly to fill with enough blood.
Currently, many people with these conditions are treated with medicines to control their heart rate. However, researchers are exploring if a different approach might be more effective. This study will look at a treatment that involves two parts: first, a procedure called AV node ablation, which uses controlled heat to create a small block in an electrical pathway in your heart. This helps the heart beat more regularly. Second, a special type of pacemaker is then fitted. A pacemaker is a small device placed under the skin near your collarbone that sends electrical signals to your heart to keep it beating at a regular rhythm. The aim of having a pacemaker after the ablation is to make sure your heart gets a regular, healthy beat, preventing the irregular beats of atrial fibrillation from affecting the rest of your heart.
The main question this study wants to answer is whether combining AV node ablation with this special pacemaker can reduce serious health problems like death or needing to go to the hospital because of your heart failure, compared to just taking your usual medications. Heart failure, particularly HFpEF, is a common and serious condition, and finding better ways to manage it, especially when atrial fibrillation is also present, is very important for patients' well-being.
Key takeaways
- This study evaluates a new treatment for permanent atrial fibrillation and HFpEF.
- It compares AV node ablation with a pacemaker versus standard medication.
- The main goal is to reduce death and hospitalisations related to heart failure.
- Participants will have clinic visits at 3, 12, and 24 months.
- Participation lasts for two years.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for adults aged 18 or older who have had permanent atrial fibrillation for at least six months and have a type of heart failure called HFpEF (meaning your heart's main pumping chamber still works well, but the heart itself is stiff). You would have had to be hospitalised for heart failure at least once in the past year and have some specific results from heart tests that suggest your heart isn’t relaxing as it should. Your heart rate should also be controlled, averaging no more than 110 beats per minute over 24 hours. Participants must also be able to understand the study and agree to take part.
There are certain reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, if you have very severe kidney or lung disease, severe obesity, or if your doctor thinks you might not live for at least another year. You also can’t have certain heart conditions like some types of inherited heart muscle diseases, or if you already have a pacemaker or another similar heart device.
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?
- Have you had permanent atrial fibrillation for over six months?
- Do you have heart failure with a preserved ejection fraction (HFpEF)?
- Have you been hospitalised for heart failure at least once in the past year?
- Do you not have an existing pacemaker or similar heart device?
- Are you able to understand and consent to participating in the study?
What does participation involve?
If you join this study, there's a chance you'll either receive the new treatment (AV node ablation with a pacemaker) or continue with your standard medication. Which group you're in will be decided randomly, like flipping a coin. You won't be able to choose, nor will the doctors. After you've been assigned to a group, you'll need to visit the clinic for check-ups and tests at 3 months, 12 months, and 24 months. These visits will help the doctors see how you're doing and how well the treatments are working. The total duration of your active participation in the study will be 24 months.
Potential risks and benefits
Locations (15)
- OLV AalstVerified postcodeAalst, Belgium· Not yet recruiting
- UZ LeuvenVerified postcodeLeuven, Belgium· Not yet recruiting
- Clinique St Pierre OttigniesVerified postcodeOttignies-Louvain-la-Neuve, Belgium· Not yet recruiting
- CHRU de Brest - Hôpital de la Cavale BlancheVerified postcodeBrest, France· Not yet recruiting
- CHRU de CaenVerified postcodeCaen, France· Not yet recruiting
- CHRU de Tours - TrousseauVerified postcodeChambray-lès-Tours, France· Not yet recruiting
- CHU Grenoble AlpesVerified postcodeGrenoble, France· Not yet recruiting
- Groupe Hospitalier La Rochelle-Ré-AunisVerified postcodeLa Rochelle, France· Not yet recruiting
- CHRU LilleVerified postcodeLille, France· Not yet recruiting
- GHICL Allome - Hôpital St PhilibertVerified postcodeLomme, France· Not yet recruiting
- Clinique MillenaireVerified postcodeMontpellier, France· Not yet recruiting
- CHU de Nantes - Hôpital Nord LaennecVerified postcodeNantes, France· Not yet recruiting
Common questions
What is 'permanent atrial fibrillation'?
This is when the upper chambers of your heart beat very quickly and irregularly, and this irregular rhythm is constant and usually doesn't go back to a normal rhythm on its own or with standard treatments.
What is 'heart failure with preserved ejection fraction' (HFpEF)?
This is a type of heart failure where your heart muscle still pumps blood out well, but it's become stiff, making it harder for the heart to relax and fill properly with blood.
What is 'AV node ablation'?
It's a procedure where a small part of the electrical pathway in your heart (the AV node) is deliberately blocked using controlled heat. This helps to stop fast, irregular signals from the upper chambers from reaching the lower chambers and causing a rapid pulse.
What does a pacemaker do?
A pacemaker is a small device surgically placed under your skin. It sends out electrical pulses to ensure your heart beats at a regular and appropriate rate, especially after an AV node ablation makes your heart beat slower.
Will I know which treatment I'm getting?
Patients will be randomly assigned to either receive the new treatment (ablation and pacemaker) or to continue with their standard medication. This is done to make the study fair, so you won't be able to choose which group you are in.
How to find out more
Tessa BERGOT, MSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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