RecruitingOBSERVATIONAL

Hamburg AoRtic Valve cOhoRt

This study, called the Hamburg Aortic Valve Cohort, is looking for the best treatments for people with a common heart problem called aortic valve disease, specifically aortic stenosis. This is a condition where the main valve in your heart doesn't open properly. Currently, serious cases often need the valve to be replaced, either through traditional open-heart surgery (SAVR) or a less invasive procedure called TAVI. Doctors want to understand which treatment is best for each individual patient, taking into account their overall health and expected recovery. They are also investigating how factors like age, other health conditions, and signs in the blood might affect how well someone does after treatment, to help them make better decisions for patients in the future.

At a glance

Status

Recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

15,000

Start

01 Sep 2019

Estimated completion

01 Sep 2049

Aortic Valve Stenosis

What is this study about?

When your heart beats, it pumps blood around your body. A very important part of your heart is a valve called the aortic valve, which opens and closes to let blood flow out smoothly. Sometimes, this valve can become stiff or narrowed, a condition called aortic stenosis. This means your heart has to work much harder to pump blood, and it can cause problems like breathlessness, chest pain, or feeling faint. If it's severe, it can be very serious.

Currently, if you have severe aortic valve disease, doctors usually recommend replacing the faulty valve. There are two main ways to do this: traditional open-heart surgery (called SAVR) or a less invasive procedure where a new valve is put in through a small cut, often in the leg (called TAVI). TAVI is a newer option, especially for people who might be at higher risk for open-heart surgery. However, doctors are still learning when TAVI is the very best choice, and how it compares to surgery for all types of patients.

This study aims to find out which treatment works best for different people. It will look at things like your general health, specific details of how the procedure was done, and certain markers in your blood, to see how they affect your recovery and long-term health. The goal is to help doctors make more informed decisions about the best treatment for each individual patient, ensuring they get the most suitable and effective care for their specific situation.

Key takeaways

This study aims to find the best treatments for aortic valve disease.
It compares traditional surgery (SAVR) with a less invasive procedure (TAVI).
It also looks at how different factors affect patient recovery.
Participation involves sharing medical information, not receiving new treatments.
The goal is to improve care decisions for future patients.

Who may be eligible?

To be able to take part in this study, you must have a significant problem with your aortic valve. This includes conditions where the valve is narrowed (aortic stenosis), leaks (aortic regurgitation), or if you have an artificial valve that is starting to wear out. You also need to be able to read and understand information about the study and agree to take part in writing.

However, there are a few reasons why you might not be able to join. If you can't understand or speak German well enough to follow the study instructions, or if other physical or mental health issues would prevent you from taking part safely, you wouldn't be able to join. The study is open to both men and women, aged 18 years and older, with no upper age limit.

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.

Do I have problems with my aortic valve (narrowing, leaking, or a worn-out artificial valve)?
Am I over 18 years old?
Can I understand and agree to the study in writing?
Do I speak and understand German well enough for study materials?

Answer every question to see your result.

What does participation involve?

The study aims to follow patients over time, rather than involving specific treatments beyond your normal medical care. If you join, the study will gather information about your health, any procedures you have (like a valve replacement), and your recovery. This will likely involve collecting notes from your medical appointments, and potentially some blood samples, which would happen during your routine visits. There are no extra medications or special appointments just for the study itself; it will mostly observe your health journey as you go through your standard treatment. The total length of your participation would depend on how long the study continues to follow patients, but you would be kept informed.

Potential risks and benefits

Taking part in this study primarily involves sharing your health information so doctors can learn more about aortic valve disease and its treatments. There are no direct medical benefits to you personally from joining, as it doesn't offer a new treatment, but your participation helps improve care for future patients. The risks are generally very low, mainly involving the commitment of time to provide information or allow access to your medical records. As with any study, you are always free to change your mind and withdraw at any point without it affecting your medical care.

Locations (1)

Universitäres Herz- und Gefäßzentrum
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What is aortic valve disease?

It's a condition where the main valve in your heart (the aortic valve) doesn't work properly, either by not opening fully or leaking, making your heart work harder.

What treatments are they comparing?

They are comparing standard valve replacement surgery (SAVR) with a less invasive procedure called TAVI, and also looking at medical treatments.

Do I have to try a new treatment if I join?

No, this study observes your standard care. You will receive the treatment your doctor recommends as best for you, and the study will gather information about it.

How long will I be in the study?

The study aims to follow patients over time, so the length of your participation would depend on the study's duration. You'll be informed of the details if you're eligible.

Who is running this study?

This study is called the Hamburg Aortic Valve Cohort, suggesting it's managed by a group in Hamburg, likely a hospital or research institution.

How to find out more

Moriz Seiffert, MD

m.seiffert@uke.de +49407410 Official trial record

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