Valved Graft PMCF Study
This study is about a new heart valve and blood vessel replacement, called an 'Abbott Valved Graft,' used during heart surgery. It's for people with conditions like problems with their aortic valve or issues with the main blood vessel leaving the heart (aorta). Doctors want to see how well this device works in real-world settings after it has been approved for use. The study will involve many hospitals globally, and everyone who joins will receive this specific device. It's designed to gather more information about its safety and how effectively it helps patients recover and live better lives. It's not comparing it to other treatments, but rather observing how it performs in those who receive it.
At a glance
What is this study about?
This study is looking at a special type of heart valve replacement called an 'Abbott Valved Graft'. This device is used during heart surgery when someone has issues with their aortic heart valve – one of the important valves that controls blood flow from your heart – or problems with the main blood vessel that carries blood from your heart to your body, called the aorta.
The main goal of this study is to check how well this Abbott Valved Graft works in patients after it's been used in many different hospitals around the world. It’s part of a process where doctors continue to learn more about new medical devices once they are available for general use. They want to make sure it’s safe and effective in a wide range of people.
By carefully watching patients who receive this device, doctors hope to gather important information. This will help them understand more about how the device performs over time, how it affects patients' health, and whether it improves their lives. This kind of study is really important for making sure medical treatments are the best they can be.
Key takeaways
- The study assesses a specific heart valve and vessel replacement device, the 'Abbott Valved Graft'.
- It's for adults needing heart surgery for aortic valve or aorta problems.
- Every participant will receive the Abbott Valved Graft during surgery.
- The study aims to observe the device's performance in real-world patients.
- It's a global study, collecting information from many hospitals.
- Participation involves receiving the device and having your health monitored.
Who may be eligible?
To be considered for this study, you would need to be an adult (18 years or older) and require heart surgery that involves replacing either your natural heart valve or an artificial one, using an Abbott Valved Graft.
However, there are certain situations where you would not be able to join. For example, if you can't take blood-thinning medication (anticoagulation therapy) when it's needed, or if you have an active infection in your heart (called endocarditis). Also, if your doctor believes there are other medical, physical, mental, or social reasons why taking part wouldn't be safe or appropriate for you.
- Are you 18 years old or older?
- Do you need heart surgery to replace a heart valve or part of your aorta?
- Can you take blood-thinning medication if your doctor says you need to?
- Do you currently have an active heart infection?
- Has your doctor said there are no other health reasons preventing you from joining?
- Do you understand what the surgery involves?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will undergo heart surgery where an Abbott Valved Graft device will be implanted to treat your heart condition. The study doesn't involve any extra treatments beyond the standard surgical procedure with this specific device. Your medical team will then closely monitor your health and recovery over a period of time, using regular check-ups and standard medical tests. The exact number of visits and tests will be explained by your doctor. The total duration of your participation will depend on the study's follow-up schedule, which aims to track your progress after surgery.
Potential risks and benefits
Locations (25)
- University Hospital - Univ. of Alabama at Birmingham (UAB)Birmingham, United States· Withdrawn
- University of MichiganAnn Arbor, United States· Recruiting
- Mission Health & HospitalsAsheville, United States· Withdrawn
- Hospital of the University of PennsylvaniaPhiladelphia, United States· Recruiting
- University of Pittsburgh Medical CenterPittsburgh, United States· Recruiting
- Klinik FloridsdorfVienna, Austria· Recruiting
- RigshospitaletCopenhagen, Denmark· Recruiting
- CHU de Besancon - Jean MinjozBesançon, France· Recruiting
- CHRU LilleLille, France· Recruiting
- Groupe Hospitalier Bichat - Claude BernardParis, France· Recruiting
- Herz-und Diabetes Zentrum NRWBad Oeynhausen, Germany· Recruiting
- Deutsches Herzzentrum BerlinBerlin, Germany· Recruiting
+13 more sites — see the official record for the full list.
Common questions
What kind of heart problems is this study for?
This study is for people who have issues with their aortic heart valve or problems with the main blood vessel leaving the heart, called the aorta.
What is an 'Abbott Valved Graft'?
It's a special type of replacement device for a heart valve and a section of the main blood vessel (aorta) that is used during heart surgery.
Will I get this device if I join?
Yes, everyone who joins this particular study will have the Abbott Valved Graft device implanted during their surgery.
Is this a new treatment still being tested?
This study is looking at how the device performs in patients after it's already been approved for use, gathering more real-world information.
Can I leave the study if I change my mind?
Yes, you can decide to stop participating in the study at any time, and this will not affect your medical care.
How to find out more
Paolo Amato
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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