Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
This study is for people in the UK who have an irregular heartbeat called Atrial Fibrillation (AF). It investigates a new way to treat AF by combining two common procedures into one. First, a treatment to help your heart beat more regularly. Second, a small device called an occluder is placed in your heart to reduce your risk of stroke, which can be higher with AF. The study aims to find out if performing these two procedures at the same time is safe, easy to do, and effective for patients who need both. It's an important step to see if this combined approach could offer a better way to manage AF and prevent related health problems.
At a glance
What is this study about?
This study is called "Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration." It's looking at people who have a common heart condition called Atrial Fibrillation, or AF for short. AF causes your heart to beat irregularly, which can make you feel unwell and also increases your risk of having a stroke.
Doctors often treat AF in two main ways: one is to try and get your heart back into a regular rhythm (this is called ablation), and the other is to reduce your stroke risk by closing off a small pouch in your heart called the Left Atrial Appendage (this is called LAA occlusion). Usually, these procedures are done separately. This study wants to see if combining them into one procedure could be safe and work well for patients who need both treatments.
The main goal is to find out if using a new system for the rhythm treatment and a specific device for the stroke prevention at the same time is a good idea. They want to check if it's safe for patients, if the doctors can do it easily, and if it's effective in treating AF and reducing stroke risk. This research could help doctors understand if a combined approach is a better option for some people with AF.
Key takeaways
- This study is for people with Atrial Fibrillation (AF) who need both AF rhythm treatment and stroke risk reduction.
- It tests combining two procedures – AF ablation and LAA occlusion – into a single operation.
- The main aim is to check the safety and how well this combined approach works.
- You would need to take specific blood-thinning medicines after the procedure.
- If eligible, you'll have follow-up visits to monitor your health and the treatment's success.
Who may be eligible?
To be considered for this study, you would need to be 18 years old or older and willing to give your written consent to take part. Doctors will check your medical history to see if you have certain risk factors for stroke (your CHA2DS2-VASc score needs to be at least 3 if you're a woman, or 2 if you're a man).
You must also have been diagnosed with a specific type of AF that causes symptoms, and your doctor thinks a procedure to correct your heart rhythm (called catheter ablation) would be suitable for you. This could be AF that comes and goes (paroxysmal AF) or AF that lasts longer (persistent AF).
There are also some reasons why you wouldn't be able to join. For example, if you have certain allergies to medications used after the procedure, or if you have an artificial heart valve or certain other medical devices already in your body. The study team will review all your health information carefully to see if this study is right 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?
- Do you have symptomatic Atrial Fibrillation (AF) that doctors say can be treated with ablation?
- Do you have a specific risk factor score for stroke (CHA2DS2-VASc at least 3 for women, or 2 for men)?
- Are you able to take blood-thinning medications as prescribed after the procedure?
- Do you currently have an artificial heart valve or certain other heart devices?
What does participation involve?
The detailed information about what participating in this study involves isn't fully provided here, but generally in similar studies, you might expect several steps. Before you decide to join, you'll have a chance to ask questions and will need to give your informed consent. If you're eligible, you would likely undergo the combined procedure where doctors will use specific devices to treat your irregular heartbeat and place a device to reduce your stroke risk.
After the procedure, you would need to take specific medications. Initially, you'd likely take blood-thinning medication for at least 60 days, followed by a different type of blood-thinning medication (antiplatelet) for a period. You would also have several follow-up appointments, which may include tests and check-ups to monitor your recovery, how the devices are working, and your overall health. These appointments help the study team understand the safety and effectiveness of the combined treatment. The total length of your participation would be explained to you before you agree to join.
Potential risks and benefits
Locations (13)
- UZ BrusselVerified postcodeBrussels, Belgium· Not yet recruiting
- Motol and Homolka University HospitalVerified postcodePrague, Czechia· Recruiting
- RigshospitaletVerified postcodeCopenhagen, Denmark· Not yet recruiting
- Cardioangiologisches Centrum am Bethanien KrankenhausVerified postcodeFrankfurt am Main, Germany· Not yet recruiting
- Universitätsklinikum Schleswig-Holstein - Campus LübeckVerified postcodeLübeck, Germany· Not yet recruiting
- Deutsches Herzzentrum der ChariteVerified postcodeBerlin, Germany· Not yet recruiting
- Mater Private HospitalVerified postcodeDublin, Ireland· Not yet recruiting
- Centro Cardiologico MonzinoVerified postcodeMilan, Italy· Recruiting
- ASST Grande Ospedale MetropolitanoVerified postcodeMilan, Italy· Not yet recruiting
- Vilnius University Hospital Santaros KlinikosVerified postcodeVilnius, Lithuania· Not yet recruiting
- Slaskie Centrum Chorob SercaVerified postcodeZabrze, Poland· Not yet recruiting
- Hospital de la Santa Creu I Sant PauVerified postcodeBarcelona, Spain· Not yet recruiting
Common questions
What is Atrial Fibrillation (AF)?
AF is a common heart condition where the upper chambers of your heart beat irregularly, which can make you feel breathless or tired and increases your risk of stroke.
What does 'ablation' mean for AF?
Ablation is a procedure where doctors use heat or cold to create tiny scars in your heart tissue to block faulty electrical signals and help your heart beat more regularly.
What is an 'LAA occluder implant'?
It's a small device that doctors place in a pouch in your heart (the Left Atrial Appendage) to seal it off. This helps prevent blood clots from forming there, which reduces your risk of stroke.
Why combine these two procedures?
This study is looking to see if doing both the irregular heartbeat treatment and the stroke prevention procedure at the same time is safe, effective, and potentially a better option for people who need both.
Will I need to take medication after the procedure?
Yes, you will need to follow a specific plan of blood-thinning medications for a period after the combined procedure to help prevent blood clots.
How to find out more
Abeer Madbouly, Ph. D
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.