Innoventric Trillium™ Stent Graft First-in-Human (FIH) Study
This study is testing a new medical device called the Innoventric Trillium™ Stent Graft. It's designed to help people who have a heart condition called tricuspid regurgitation, where one of the heart valves doesn't close properly, causing blood to leak backward. This can lead to symptoms like tiredness and shortness of breath. The study aims to find out if this new device is safe and effective for patients. It's an early-stage study, meaning it's one of the first times this device is being used in people. Doctors will carefully monitor 20 participants over three years to see how they respond to the treatment and how the device performs.
At a glance
What is this study about?
This study is about a new treatment for a heart condition called tricuspid regurgitation. This happens when the tricuspid valve, one of the four valves in your heart, doesn't close tightly. This causes blood to flow backwards, putting strain on your heart and leading to symptoms like swelling, shortness of breath, and tiredness. For many people, existing medicines might not fully control these symptoms.
The new treatment being tested is a device called the Innoventric Trillium™ Stent Graft. This device is designed to help the tricuspid valve work better. Think of it like a small, specially designed scaffold that helps support the leaky valve. This study is important because it's the first time this specific device is being used in people, so doctors want to make sure it's safe and that it helps patients feel better.
Researchers will carefully follow 20 patients in 8 different hospitals. They will compare how patients are doing before the device is put in, and then regularly check on them for up to three years afterwards. This long-term monitoring helps ensure they gather enough information about how the device works over time and if it improves patients' quality of life.
Key takeaways
- Tests a new device for a leaky heart valve (tricuspid regurgitation).
- Focuses on people whose symptoms aren't fully controlled by medication.
- Aims to check if the new device is safe and helps improve symptoms.
- Involves regular check-ups over three years.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, participants generally need to be over 40 years old and have severe tricuspid regurgitation that causes noticeable symptoms, even with current medication. Your heart's medical team will need to confirm that this treatment might be a good option for you, especially if standard operations or procedures aren't suitable or haven't worked.
However, there are also reasons why someone might not be able to join. For example, if you have other serious heart problems like very weak heart pumping function, severe narrowings of other heart valves, or blood clots in your heart. You also can't join if you've had a recent heart attack or have certain infections in your heart.
The medical team will do thorough checks to make sure the device can be safely put in and that you meet all the necessary health requirements to take part in the study.
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 over 40 years old?
- Do you have severe tricuspid regurgitation causing symptoms?
- Are your symptoms not well controlled by your current medications?
- Has your heart team suggested that surgery isn't the best option for you?
- Are you willing to attend regular follow-up appointments for three years?
What does participation involve?
If you decide to take part, you'll have several visits to the hospital. First, there will be a thorough check-up before the device is put in. The device procedure itself involves a hospital stay. After you go home, you'll have follow-up visits after 1 month, 3 months, 6 months, 1 year, 1 and a half years, 2 years, and finally 3 years after the procedure.
During these visits, doctors will perform various tests to see how you're recovering and how the device is working. This will include checks of your heart and overall health. You won't need to take any experimental medications, as the study focuses on the device itself. The total duration of your participation will be three years, during which you'll be carefully monitored by the study team.
Potential risks and benefits
Locations (9)
- OLVZ AalstVerified postcodeAalst, Belgium
- ZNAVerified postcodeAntwerp, Belgium
- Heart & Diabetes Center NRWVerified postcodeBad Oeynhausen, Germany
- Herzzentrum der Charité (DHZC)Verified postcodeBerlin, Germany
- Leipzig Heart CenterVerified postcodeLeipzig, Germany
- Rabin Medical CenterVerified postcodePetah Tikva, Israel
- Hospital Clinic de BarcelonaVerified postcodeBarcelona, Spain
- Hospital Universitario de SalamancaVerified postcodeSalamanca, Spain
- Hospital Alvaro Cunqueiro, Hospital Universitario de VigoVerified postcodeVigo, Spain
Common questions
What is tricuspid regurgitation?
It's a heart condition where one of your heart valves, the tricuspid valve, doesn't close properly, causing blood to leak backwards in your heart.
What is the Trillium™ Stent Graft?
It's a new medical device being tested in this study, designed to help improve the function of the leaky tricuspid valve.
How long will the study last for me?
If you join, you will be followed by the study team for three years after the device is put in.
Will I have to take new medications?
No, this study is about a device, not new medications. You'll continue with your regular treatments unless your doctor advises otherwise.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and this won't affect 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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