Feasibility Study to Evaluate the Safety of the Autologous GrOwnValve Transcatheter Pulmonary Heart Valve
This study is looking into a new type of heart valve replacement called the GrOwnValve. It's designed to be safer and more effective, especially for children, but this first study is testing it in adults aged 18 and over. The GrOwnValve is unique because it's made from your own body tissue, which means it might be able to grow and repair itself, unlike current artificial valves. This could be a big step forward for people with faulty pulmonary heart valves, a condition called pulmonary valve insufficiency. The study will check if the GrOwnValve is safe and start to look at how well it works.
At a glance
What is this study about?
Imagine a tiny but crucial part of your heart, a valve, isn't working as it should. This is called pulmonary valve insufficiency, and it means the valve doesn't close properly, letting blood leak back into the heart. If this isn't sorted, it can lead to serious heart problems over time.
For a long time, the options for fixing these valves, especially in children, haven't been ideal. Existing valves don't grow with a child or repair themselves, meaning many operations may be needed. That's why researchers have developed the GrOwnValve. This new valve is made from a patient's own tissue, like from their chest lining or thigh muscle. The idea is that because it's living tissue, it might be able to grow and adapt with the child, and even repair itself over time. This could dramatically change how we treat heart valve problems.
This specific study is the very first time the GrOwnValve is being tested in humans. While the goal is to help children, this initial study is looking at adults (aged 18 and over) to carefully check its safety. Researchers will also be looking to see early signs of how well it works. They hope the GrOwnValve will eventually become the standard way to replace faulty heart valves, offering a much better solution than what's currently available.
Key takeaways
- The GrOwnValve is a new type of heart valve made from your own tissue.
- It's designed to grow with the patient and potentially repair itself.
- This first study is testing its safety in adults with a specific heart valve problem.
- The valve is inserted using a less invasive procedure, not open-heart surgery.
- It could offer a long-lasting solution, reducing the need for multiple operations.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a problem with your pulmonary heart valve that's causing moderate or severe leaks. You'll also need to have enough suitable tissue in your body that can be used to create the new valve. This tissue is typically taken from the lining around your heart or from your thigh.
There are also some reasons why you might not be able to join. For example, if you have certain heart infections, or if you've had a recent heart attack. People with certain other serious health problems, like advanced lung conditions, specific immune system disorders, or some connective tissue diseases, also wouldn't be able to take part. Women who are pregnant, breastfeeding, or could become pregnant and aren't using effective contraception also wouldn't be eligible. The hospital team will check all these details carefully with 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 of age or older?
- Do you have moderate or severe leaking of your pulmonary heart valve?
- Are you generally in good health apart from your heart condition?
- Are you able to agree to the study in writing and attend follow-up appointments?
- Are you not currently pregnant or breastfeeding, and for women, are you using effective contraception if applicable?
What does participation involve?
If you decide to take part, a key step will be having either an operation to collect your tissue for the valve or a less invasive procedure like a keyhole surgery. This tissue will then be used to create your custom GrOwnValve. After the valve is made, it will be carefully inserted into your heart using a special tube ('catheter') that's guided through a blood vessel, usually in your leg or neck. This is a less invasive procedure than open-heart surgery.
You will have regular appointments for check-ups, which will include heart scans like echocardiograms (ultrasound of the heart) and MRI scans to see how the valve is working and how your heart is responding. These checks will help the doctors make sure the valve is safe and working effectively. The total duration of your participation in the study, including follow-up appointments, will be explained fully by the study team.
Potential risks and benefits
Locations (1)
- Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Deutsches Herzzentrum der CharitéVerified postcodeBerlin, Germany· Recruiting
Common questions
What exactly is the GrOwnValve?
It's a new heart valve designed to replace a faulty pulmonary valve. It's special because it's made from your own body tissue, which is hoped will allow it to grow and adapt over time.
Why is this study only for adults if the valve is for children?
This is the very first time the GrOwnValve is being tested in humans. Starting with adults first allows researchers to carefully check the valve's safety before it's considered for children.
What kind of heart problem is this valve for?
It's for people with "pulmonary valve insufficiency," which means the valve controlling blood flow out of the heart isn't closing properly, causing blood to leak back.
Will I need surgery to get the GrOwnValve?
The GrOwnValve is inserted using a less invasive procedure where a tube is guided through a blood vessel, rather than traditional open-heart surgery. However, you will need a minor procedure to collect tissue for the valve.
How long will I be involved in the study?
The study involves an initial procedure to implant the valve, followed by regular check-ups and heart scans over a period of time. The study team will give you a detailed timeline.
How to find out more
Boris Schmitt, Dr.
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.