MitraClip® Registry
This study is called the MitraClip® Registry. It's collecting important information from people in the UK who are undergoing a procedure called MitraClip®. This treatment is for a heart condition known as mitral regurgitation, where one of the heart's valves doesn't close properly, causing blood to leak backward. The MitraClip® procedure offers an alternative for patients who might find traditional open-heart surgery too risky. By gathering details about these patients' health and how they recover after the MitraClip® procedure, doctors can learn more about how effective and safe this treatment is in the long term. This helps improve care for future patients with similar heart conditions.
At a glance
What is this study about?
This study is called the MitraClip® Registry. It's designed to collect important information about people who are receiving a special heart treatment called MitraClip®. This treatment is for a common heart problem known as mitral regurgitation. In simple terms, mitral regurgitation means that one of the valves in your heart, called the mitral valve, isn't closing properly. This causes some blood to leak backward each time your heart beats, making your heart work harder.
The MitraClip® procedure is a less invasive way to fix this leaking valve, meaning it doesn't usually involve open-heart surgery. It's often offered to patients who might be too unwell or have other health issues that make traditional surgery too risky. Think of it like a tiny clip that helps the valve close better.
By carefully observing and collecting health details from many patients who undergo the MitraClip® procedure, doctors and researchers can learn a great deal. They want to understand who benefits most from the treatment, how well it works over time, and what the long-term results are. This information is vital for improving how we treat mitral regurgitation in the future and ensuring patients receive the best possible care.
Key takeaways
- This study collects real-world information about the MitraClip® heart procedure.
- It helps doctors understand how well the MitraClip® works for a leaking heart valve (mitral regurgitation).
- You won't have extra appointments or treatments because of the study.
- Your health details will help improve care for future patients.
- You can decide to stop participating at any time.
Who may be eligible?
To take part in this study, you would need to have been diagnosed with severe mitral regurgitation. This means that your heart's mitral valve is leaking quite badly.
You would also need to be undergoing the MitraClip® procedure to fix this leaking valve. This study is specifically looking at people who are receiving this type of treatment.
There are a few reasons why you might not be able to join. You must be at least 18 years old. Also, if your heart care team, after careful consideration, believes that the MitraClip® procedure isn't likely to significantly help you or provide lasting health benefits, then you wouldn't be able to participate.
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.
- Have I been diagnosed with severe mitral regurgitation?
- Am I planned to have the MitraClip® procedure?
- Am I 18 years old or older?
- Does my heart care team believe the MitraClip® procedure will genuinely help me?
What does participation involve?
This study is an 'observational study,' which means you wouldn't be asked to take any new medication or have different treatments than what your doctors already recommend. Instead, the study will simply collect information about your health and your experience with the MitraClip® procedure.
The research team will gather details from your regular medical appointments and follow-up care that you would be receiving anyway. This includes information about your initial heart condition, the MitraClip® procedure itself, and how you recover afterwards. Your involvement in the study would continue for an open-ended period, meaning they will keep collecting information about your progress over time as part of your routine care.
Potential risks and benefits
Locations (1)
- Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae MedicineVerified postcodeDüsseldorf, Germany· Recruiting
Common questions
What is mitral regurgitation?
Mitral regurgitation is a heart condition where one of your heart valves, called the mitral valve, doesn't close completely, causing blood to leak backwards.
What is the MitraClip® procedure?
The MitraClip® is a small device inserted into your heart in a less invasive way, helping your mitral valve close more effectively to reduce the leaky blood flow.
Will taking part mean extra doctor's appointments?
No, this study simply collects information from your routine medical appointments and check-ups you'd be having anyway. There are no additional visits for the study.
Do I have to take new medicine if I join?
No, this study is just observing your existing treatment. You won't be asked to take any new medications or receive different treatments as part of the study.
What happens to my personal information?
Your privacy is very important. The study will collect health information, but it will be handled confidentially and used for research purposes to understand the MitraClip® treatment better.
How to find out more
Malte Kelm, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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