RecruitingOBSERVATIONAL

The Leipzig TAVI Registry

This study, called "The Leipzig TAVI Registry," is tracking patients in Leipzig, Germany, who have undergone a heart procedure known as Transcatheter Aortic Valve Implantation (TAVI). TAVI is used to treat a condition called Aortic Valve Stenosis, where the heart's aortic valve narrows, making it harder for blood to pump. The researchers are simply observing all patients who have this procedure at the Heart Center in Leipzig. They are especially interested in how well the TAVI valve lasts over a long period, with some patients being followed for up to 10 years. This helps doctors understand the long-term benefits and effectiveness of the TAVI procedure in real-world patients.

At a glance

Status

Recruiting

Sponsor

Helios Health Institute GmbH

Enrolment target

20,000

Start

01 Mar 2020

Estimated completion

31 Dec 2030

Aortic Valve Stenosis

What is this study about?

Imagine your heart has a small door, called the aortic valve, that opens and closes to let blood flow out to your body. If this door becomes stiff and narrow, a condition called `aortic valve stenosis`, it's like trying to push water through a pinched hose – it's really hard for your heart. This can make you feel tired or breathless.

Traditionally, a big operation was needed to fix this. However, there's a newer procedure called `Transcatheter Aortic Valve Implantation`, or `TAVI`. With TAVI, doctors can replace the faulty valve using a tiny tube inserted into a blood vessel, often in the leg, without opening up your chest. It's a less invasive way to help your heart work better.

"The Leipzig TAVI Registry" is not a typical medical experiment where people are given new treatments to test. Instead, it's like a watchful eye on everyone who receives the TAVI procedure at a specific hospital in Leipzig, Germany. The main goal is to simply keep track of how these patients are doing over time, focusing on how long the new valve lasts and if there are any issues. This helps doctors worldwide understand the real-life effectiveness and long-term success of the TAVI procedure.

Key takeaways

This study tracks patients who have had a TAVI heart procedure.
It helps doctors understand how the new heart valves work long-term.
Participation involves your regular check-ups, no extra procedures.
The study gathers information from all adult TAVI patients at one German hospital.
Data collected will improve heart care for people with aortic valve problems.

Who may be eligible?

This study is very straightforward about who can take part. It includes adults who have already had the TAVI procedure for their aortic valve stenosis at the Heart Center in Leipzig, Germany.

There are no specific reasons given why someone would not be included in this study, as long as they had the TAVI procedure at that hospital. It’s designed to gather information from all patients who undergo this treatment there.

So, if you're an adult and had your TAVI procedure at the Heart Center in Leipzig, you would likely be part of this ongoing registry.

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 an adult (18 years or older)?
Have you had the TAVI procedure?
Did you have your TAVI procedure at the Heart Center, Leipzig, Germany?
Do you want your routine health information to help improve care for others?

Answer every question to see your result.

What does participation involve?

If you are part of this study, you won't be given any special medication or treatment beyond what your doctors already recommend for your heart condition. Your participation primarily involves attending your regular check-ups at the hospital, which include standard medical evaluations and heart scans (called echocardiograms).

The researchers will use the information gathered during these routine appointments. The main difference is that they will continue to track your health for a long time, potentially up to 10 years. This extended follow-up helps them understand how your replacement valve performs and lasts over many years. There are no extra visits or procedures specifically for the study itself; it simply uses your routine care information.

Potential risks and benefits

Being part of this registry doesn't involve any additional medical risks beyond your standard medical care after a TAVI procedure. You won't receive extra tests or treatments specifically for the study. The main benefit is that the information gathered from your health journey contributes to a much larger understanding of how TAVI works in the long run. This knowledge can help improve care for future patients with aortic valve stenosis. You always have the right to discuss your healthcare with your doctor, and if you ever felt uncomfortable with your information being part of such a registry, you could discuss this with your care team.

Locations (1)

Herzzentrum Leipzig
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is Aortic Valve Stenosis?

It's a condition where the heart's aortic valve, which lets blood out to the body, becomes narrow and stiff, making it hard for blood to flow properly.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a keyhole heart procedure to replace the narrow aortic valve using a thin tube, usually through a blood vessel in the leg.

Is this a new treatment being tested?

No, TAVI is an established treatment. This study is simply watching how all patients who receive TAVI at one specific hospital are doing over time.

How long will patients be followed?

Patients will have routine follow-ups, and their health will be tracked for up to 10 years to see how well the new valve lasts.

Who can join this study?

This study includes adult patients who have already had the TAVI procedure at the Heart Center in Leipzig, Germany.

How to find out more

Mohamed Abdel-Wahab, MD

mohamed.bdel-wahab@medizin.uni-leipzig.de +49 341 865 1428 Official trial record

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