TRISCEND II Pivotal Trial
This important study, called TRISCEND II, is looking into a new treatment for a heart condition called tricuspid valve regurgitation. This happens when the heart's tricuspid valve doesn't close properly, causing blood to leak backward. Researchers are testing a new device, the Edwards EVOQUE system, which aims to replace the faulty valve. The study will compare patients who receive the EVOQUE system along with their usual medical care to those who only receive their usual medical care. The main goal is to find out if the EVOQUE system is safe and works well to improve symptoms and overall health for people with severe tricuspid valve problems.
At a glance
What is this study about?
The TRISCEND II study is a crucial clinical trial focusing on a specific heart valve problem called tricuspid regurgitation. Imagine your heart as a house with several doors, or valves, that open and close to keep blood flowing in the right direction. The tricuspid valve is one of these doors, located on the right side of your heart. When it has 'regurgitation,' it means the door isn't closing properly, letting blood leak backward. This can make your heart work harder and cause symptoms like tiredness or swelling.
This study is testing a new device specifically designed to help with this problem, called the Edwards EVOQUE system. It's a type of replacement valve that can be put in without major open-heart surgery. The researchers want to understand if this new device is a safe and effective way to treat severe tricuspid regurgitation. They're comparing it to the standard care, which includes medications and regular check-ups, often called 'optimal medical therapy' (OMT).
By comparing these two approaches, the study hopes to gather strong evidence about whether the EVOQUE system can significantly improve the health and well-being of people suffering from this condition. Findings from trials like this are incredibly important because they help doctors make better decisions about the best treatments available for patients in the future.
Key takeaways
- Tests a new device (EVOQUE system) for severe tricuspid valve problems.
- Compares the device plus regular care to regular care alone.
- Aims to check if the device is safe and effective.
- Involves regular check-ups for up to five years.
- Participation could mean getting a new treatment not yet widely available.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a problem with your tricuspid heart valve that your doctor considers to be at least 'severe.' You should also be getting standard medical care for your heart condition, including any necessary medications.
Your heart team, which is a group of specialists, would need to agree that the new tricuspid valve replacement device being tested is a suitable option for you. Importantly, you must be willing to attend all study appointments and be able to provide your written permission to take part.
There are also some reasons why you might not be able to join. For example, if your heart is too weak, or if a previous heart surgery or another heart valve problem makes the new device unsuitable. Also, if you have certain lung pressure issues, or if you've recently had an infection or other heart procedures, you might not be eligible. The study 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 old or older?
- Do you have severe tricuspid valve leakage?
- Are you currently receiving usual medical care for your heart condition?
- Has your heart specialist team considered the new device for you?
- Are you able to attend follow-up appointments for up to 5 years?
What does participation involve?
If you decide to join this study, you will first have a thorough check-up to make sure you meet all the requirements. If you do, you'll either receive the new EVOQUE device along with your usual medical care, or you'll continue with your usual medical care alone. This choice is made randomly, like flipping a coin, to ensure a fair comparison.
You will have several follow-up appointments. These will happen shortly after leaving the hospital, then at 30 days, 3 months, 6 months, and every year for up to five years. During these visits, the study team will check how you're feeling, conduct scans, and ask about your health to see how you're responding to treatment. The total duration of your involvement will be up to five years.
Potential risks and benefits
Locations (62)
- SJHMC Heart and Vascular InstituteVerified postcodePhoenix, United States
- Tucson Medical CenterVerified postcodeTucson, United States
- Scripps Memorial Hospital La JollaVerified postcodeLa Jolla, United States
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States
- UC Davis Medical CenterVerified postcodeSacramento, United States
- Kaiser Permanente San FranciscoVerified postcodeSan Francisco, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Stanford UniversityVerified postcodeStanford, United States
- Medical Center of the RockiesVerified postcodeLoveland, United States
- Florida Heart & Vascular Care - JFKVerified postcodeAtlantis, United States
- The Cardiac & Vascular Institute Research FoundationVerified postcodeGainesville, United States
- NCH Heart InstituteVerified postcodeNaples, United States
Common questions
What is tricuspid valve regurgitation?
It's a heart condition where the tricuspid valve, one of the heart's doors, doesn't close properly, letting blood leak backward.
What is the Edwards EVOQUE system?
It's a new device designed to replace a faulty tricuspid valve, potentially without the need for major open-heart surgery.
Will I definitely get the new device if I join?
No, whether you get the device or only continue with your usual medical care will be decided randomly, like drawing lots.
How long will I be involved in the study?
You will be followed by the study team for up to five years, with regular check-ups during that time.
Can I leave the study if I change my mind?
Yes, you are free to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.