RecruitingNAINTERVENTIONAL

TriRec - Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium

This study, called TriRec, is comparing a new surgical method for treating a heart condition called aortic valve disease. Aortic valve disease means the valve letting blood out of your heart isn't working properly. The study looks at rebuilding the valve using some of your own body tissue, specifically from around your heart (called autologous pericardium). This new method is being compared to the standard operation where a biological valve (like the St. Jude Trifecta GT) is used to replace the faulty one. The main goal is to see if rebuilding the valve with your own tissue is just as good as the standard replacement in terms of how well blood flows through it after surgery. This could offer a different option for people needing aortic valve treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Deutsches Herzzentrum Muenchen

Enrolment target

128

Start

18 Jan 2018

Estimated completion

01 Jan 2030

Alternative Surgical Treatment for Aortic Valve Disease

What is this study about?

This study is investigating a new surgical approach for people who have problems with their aortic valve, which is one of the important valves in your heart. When this valve doesn't open fully or leaks, it can cause symptoms like breathlessness or chest pain. The study is called TriRec, and it’s looking at a technique where surgeons carefully reconstruct your aortic valve using a small piece of tissue taken from around your own heart. This natural tissue is used to create three new leaflets for the valve, helping it to work properly again.

The main aim of this research is to see how this new reconstruction method compares to the usual operation for aortic valve disease, which is called a surgical aortic valve replacement (SAVR). In a SAVR, the faulty valve is removed and replaced with a new one, often a biological valve made from animal tissue. Doctors want to find out if rebuilding the valve with your own tissue works just as well as these standard replacement valves in letting blood flow efficiently out of your heart after the operation.

Finding alternative ways to treat aortic valve disease is important because each patient is different, and some may benefit more from one type of procedure over another. If this reconstruction method proves to be as effective, it could offer another valuable option for people needing this type of heart surgery in the future.

Key takeaways

This study compares a new valve repair (TriRec) to standard replacement surgery.
TriRec uses your own body tissue to fix the heart valve.
It aims to see if the new method is just as effective as the usual operation.
The study is for people aged 50 or over with a specific aortic valve problem.
Participation involves surgery and follow-up appointments.

Who may be eligible?

You might be able to take part in this study if you are 50 years old or older and have been diagnosed with a moderate or severe problem with your aortic valve that is causing symptoms. Your aortic valve also needs to be a certain size (larger than 19mm).

There are some reasons why you might not be able to join. For example, if you need other heart operations at the same time, or if you've recently had a stroke or mini-stroke. Conditions such as certain blood clotting problems, or if you have a very brittle aorta (the main artery from your heart), would also mean you couldn't take part.

Also, if you are currently pregnant, have an active infection, or have had previous heart surgery (unless it was a keyhole procedure), you wouldn't be eligible. The study is for both men and women.

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 50 years old or older?
Do you have a moderate or severe aortic valve problem causing symptoms?
Have you *not* had a stroke or mini-stroke within the last 6 months?
Are you *not* pregnant?
Have you *not* had previous heart surgery (unless it was a keyhole procedure)?

Answer every question to see your result.

What does participation involve?

The detailed parts of participating in this study would be explained fully by the research team. Generally, if you agree to take part, you would undergo either the new TriRec operation or the standard aortic valve replacement surgery. You would have planned follow-up appointments and checks after your surgery, which would involve medical assessments and scans to see how your new or repaired valve is working. You would continue to be monitored over time to track your progress and valve function. The exact number of visits, tests, and the total duration would be discussed with you, but typically, surgical studies involve follow-ups for several months or even a few years.

Potential risks and benefits

Potential benefits of participating could include receiving a treatment that may be an effective alternative to standard surgery, and contributing to medical knowledge that could help future patients. As with any surgery, there are potential risks, including those related to the operation itself, anaesthesia, and recovery, which your medical team will discuss thoroughly with you. You will be closely monitored throughout the study. It’s important to remember that participating is completely voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Department of Cardiovascular Surgery, German Heart Center Munich
Verified postcode
Munich, Germany· Recruiting

Common questions

What is aortic valve disease?

It's a condition where the valve that lets blood leave your heart doesn't open properly or leaks, making your heart work harder.

What is the TriRec operation?

It's a new surgery where parts of your own heart tissue are used to rebuild your aortic valve instead of replacing it with an artificial one.

How is it different from standard surgery?

Standard surgery usually replaces the faulty valve with a new one, often made from animal tissue. TriRec rebuilds it using your own tissue.

Will I know which surgery I'm getting?

The study aims to see how both approaches compare, and the research team will explain how treatment assignment works if you decide to join.

What happens after the surgery in the study?

You will have regular check-ups and tests to ensure your valve is working well and to monitor your recovery.

How to find out more

Markus Krane, MD, PhD

krane@dhm.mhn.de +4989-1218 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.