MYVAL Transcatheter Heart Valve System - Prospective German Multicenter Registry
This study, happening in Germany, is for patients with a heart condition called aortic valve stenosis. This is when the main valve in your heart, the aortic valve, becomes narrow. The study is evaluating a relatively new type of artificial heart valve called the Myval Transcatheter Heart Valve (Myval THV). Doctors want to see how well this new valve performs in everyday situations, assessing how effective it is and how long it lasts in a wide range of patients. The aim is to gather information on its long-term reliability and how it helps people's health over time. This research helps ensure new treatments are safe and work well for patients.
At a glance
What is this study about?
This research study is about a new type of heart valve replacement called the Myval Transcatheter Heart Valve, or Myval THV for short. If you have a condition called aortic valve stenosis, it means the main valve in your heart that controls blood flow from your heart to the rest of your body has become stiff and narrow. This can make your heart work harder.
Traditionally, this might have been treated with open-heart surgery, but newer methods, like the TAVR procedure that uses the Myval THV, involve placing a new valve without needing to open your chest. This particular study is happening across different hospitals in Germany. It's a 'registry' study, which means doctors are closely watching how the Myval THV performs in a wide range of patients who are receiving it as part of their normal treatment.
The main goals are to understand how effective the Myval THV is in real-life situations and how long it continues to work well. By following many patients over time, doctors can learn more about the valve's long-term performance and help make sure it's a good and reliable option for people with aortic valve stenosis.
Key takeaways
- This study is observing a new heart valve called Myval THV.
- It's for people with a heart condition called aortic valve stenosis.
- The study aims to see how well the valve works over a long time in real patients.
- You would receive the valve as part of your standard medical treatment.
- Data collected will help doctors learn about the valve's performance and safety.
Who may be eligible?
To be considered for this study, you must be at least 18 years old and be scheduled to receive the Myval Transcatheter Heart Valve as part of your treatment. It's also important that you are able to understand what the study involves and can give your permission to take part.
There are certain reasons why you might not be able to join the study. For example, if you are pregnant or breastfeeding, you won't be able to participate. Also, if you have severe allergies to common medications like aspirin or heparin, or to certain metals or dyes used in medical procedures, this study might not be suitable for you.
Finally, if your doctor believes that taking part in this study would not be safe for you, or if you cannot take certain blood-thinning medications that might be needed, you would not be able to join.
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.
- Am I 18 years old or older?
- Am I going to receive the Myval THV as part of my treatment?
- Can I understand what the study involves and agree to take part?
- Am I pregnant or breastfeeding?
- Do I have severe allergies to common medications or medical materials?
What does participation involve?
This study is a registry, which means if you receive the Myval THV as part of your treatment, your doctors will collect information about how the valve performs. You won't be asked to do anything extra or different from your usual medical care for your heart condition during the initial procedure. Your care team will simply observe and record information about how the valve works.
After your procedure, your doctors will continue to monitor your health as they normally would. The study will likely involve collecting information from your routine follow-up appointments over a longer period to understand the long-term effects of the valve. The exact number of visits and the total duration aren't specified, but it would involve gathering data during your regular check-ups.
Potential risks and benefits
Locations (1)
- Universitätsklinikum Schleswig-Holstein - Campus LübeckVerified postcodeLübeck, Germany· Recruiting
Common questions
What is Aortic Valve Stenosis?
It's a heart condition where the main valve in your heart becomes narrow, making it harder for blood to flow out to your body.
What is the Myval Transcatheter Heart Valve?
It's a new artificial heart valve that can be put into place without needing open-heart surgery, often called a TAVR procedure.
Will I get a different treatment if I join this study?
No, you will receive the Myval THV as part of your normal medical care. The study just gathers information about its performance.
How long will I be involved in the study?
The study aims to look at the long-term effects, so information will be collected during your regular check-ups over an extended period, which isn't specified but could be several years.
Can I leave the study if I change my mind?
Yes, you are free to withdraw from the study at any time, and it will not affect your medical care.
How to find out more
Ingo Eitel, Prof. Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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