Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
This study, called Tendyne RESOLVE-MR, is checking the Tendyne™ Mitral Valve System. This device is used for people who have a leaky heart valve, known as mitral regurgitation. The main goal is to see how safe the device is and how well it works in everyday medical situations. Healthcare teams decide if this treatment is right for each patient. This study is important because it helps make sure the device is safe and effective after it has been approved for use, by looking at any problems or issues that might come up over time. It’s part of a promise to keep checking how new medical devices perform in real life.
At a glance
What is this study about?
Imagine your heart has four main doors, called valves, that open and close to keep blood flowing in the right direction. One of these, the mitral valve, is between the left top and left bottom chambers of your heart. If this door doesn't close properly, some blood can leak backwards. This is called mitral regurgitation, and it can make your heart work harder.
Doctors have a treatment called the Tendyne™ Mitral Valve System. This is a special device that can replace your leaky mitral valve without needing open-heart surgery. Instead, doctors can guide it into place using a small cut in your chest, through a method called 'transapical transcatheter mitral valve implantation'. This study is like a thorough check-up on this treatment. It's designed to see how the Tendyne™ system performs in people who receive it in normal hospital settings.
This study is important because it helps ensure that new medical devices continue to be safe and effective after they are made available to patients. By carefully watching how the Tendyne™ system works for many people over time, doctors can learn more about its long-term benefits and any potential issues. This information then helps other patients and doctors make informed decisions about their care. It's all about making sure you get the best and safest treatment possible.
Key takeaways
- This study evaluates the Tendyne™ heart valve system for leaky mitral valves.
- It aims to confirm device safety and how well it works in real-world patients.
- Participation involves ongoing check-ups for up to five years.
- Doctors will decide if this treatment is suitable for your specific condition.
- The study helps ensure new medical technologies are safe and effective long-term.
Who may be eligible?
To join this study, people generally need to be at least 18 years old. They must have a leaky mitral valve (mitral regurgitation) and their heart team must believe the Tendyne™ Mitral Valve System is the right treatment for them. It's also important that they are willing and able to attend all follow-up appointments and tests for up to five years.
There are also some reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, or planning to become pregnant, you cannot take part. Also, if you are already in another medical study that might affect the results of this one, you would not be eligible. The study also cannot include individuals whose other health conditions might make it hard for them to participate safely or attend all necessary appointments.
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 or older?
- Do you have a leaky mitral valve (mitral regurgitation)?
- Are you willing and able to attend follow-up appointments for up to five years?
- Are you not pregnant or breastfeeding, and not planning to become pregnant during the study?
- Are you not currently part of another clinical study that might interfere with this one?
What does participation involve?
If you decide to take part in this study, you will receive the Tendyne™ Mitral Valve System as advised by your heart team. Your participation involves attending regular check-up appointments for up to five years after the procedure. These visits will include various tests and assessments to monitor your health and how well the device is working. You'll also need to follow any medication plans given by your doctors. Your commitment to these follow-up visits and tests is crucial for the study to gather all the necessary information.
Potential risks and benefits
Locations (36)
- Kepler University HospitalVerified postcodeLinz, Austria
- UZ GasthuisbergVerified postcodeLeuven, Belgium
- University Hospital OlomoucVerified postcodeOlomouc, Czechia
- IKEM PragueVerified postcodePrague, Czechia
- Hospital AGEL Trinec-PodlesiVerified postcodeTřinec, Czechia
- Bordeaux University HospitalVerified postcodeBordeaux, France
- CHRU de LilleVerified postcodeLille, France
- Lyon University HospitalVerified postcodeLyon, France
- Rennes University HospitalVerified postcodeRennes, France
- Clinique PasteurVerified postcodeToulouse, France
- Heart and Diabetes Center NRWVerified postcodeBad Oeynhausen, Germany
- German Heart Center BerlinVerified postcodeBerlin, Germany
Common questions
What is mitral regurgitation?
Mitral regurgitation means your heart's mitral valve isn't closing properly, letting some blood leak backwards instead of flowing forward.
What is the Tendyne™ Mitral Valve System?
It's a special device designed to replace a leaky mitral valve. It can often be put in place without major open-heart surgery.
How long does the study last?
If you join, you would need to attend follow-up appointments for up to five years after your procedure.
Will I have to pay to be part of this study?
The study itself does not typically involve direct costs to the patient, but you should discuss all financial aspects with your medical team.
What if I change my mind after joining?
You are free to leave the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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