RecruitingOBSERVATIONAL

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

This study looks at the best ways to take pictures of the main blood vessel leaving your heart (the aorta) before a procedure called Transcatheter Aortic Valve Implantation (TAVI). TAVI is a way to replace a faulty heart valve for people with a condition called aortic stenosis, especially those who are too unwell for traditional open-heart surgery. The goal is to compare different imaging methods to make sure doctors can choose the correct replacement valve and avoid problems during the TAVI procedure. This involves injecting a special dye to get clear images and then having experts review them. The study uses information from past patients and is also collecting new information.

At a glance

Status

Recruiting

Sponsor

Klinik für Kardiologie, Pneumologie und Angiologie

Enrolment target

5,000

Start

01 Jan 2013

Estimated completion

01 Dec 2030

Aortic Valve Stenosis

What is this study about?

Imagine your heart has a main door (the aortic valve) that helps blood flow out to your body. If this door gets stiff and doesn't open properly, it's called aortic stenosis. This can make your heart work harder and cause symptoms like breathlessness or chest pain.

For some people with severe aortic stenosis, open-heart surgery to replace the valve can be too risky. In these cases, a procedure called Transcatheter Aortic Valve Implantation (TAVI) offers another option. TAVI involves putting a new valve into your heart using a thin tube, usually inserted through a blood vessel in your leg, without the need for major open surgery.

Before a TAVI procedure, it's really important for doctors to get very clear pictures of your heart's main artery (called the aortic root) and the old valve. These pictures help them choose the right size and type of new valve and plan the procedure carefully to avoid problems. This study aims to compare different methods of taking these pictures to find out which ones give the most accurate and helpful information. This will help doctors make the TAVI procedure as safe and successful as possible for patients.

Key takeaways

The study aims to improve TAVI procedures for patients with aortic stenosis.
It compares different ways of taking pictures of the heart before TAVI.
The goal is to help doctors choose the right replacement valve and avoid problems.
Participation involves no extra procedures beyond your usual pre-TAVI checks.
Information from the study could make TAVI safer and more effective for future patients.

Who may be eligible?

To be considered for this study, you would need to have a heart valve problem called aortic stenosis, which means your aortic valve isn't opening properly. You would also need to have been assessed by doctors who are considering you for a TAVI procedure.

If you meet these general criteria, the next step would be to provide your informed consent. This means a doctor would explain the study to you in detail, answer all your questions, and you would then agree in writing to take part. Only people who are able to understand and provide this consent can join the study.

Essentially, if you are an adult with aortic stenosis being considered for TAVI and are able to understand and agree to participate, you might be eligible.

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 you have a heart condition called aortic stenosis?
Are your doctors considering TAVI as a treatment option for you?
Are you 18 years old or older?
Are you able to understand study information and agree to take part?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need to do anything extra beyond what would normally happen before a TAVI procedure. The study focuses on comparing the imaging scans you would already have. You will have a special dye injected, either into your main heart artery or a chamber of your heart, to help get clear images during these scans. Expert doctors, who won't know which imaging method was used, will then review these pictures to see how well they show the important parts of your heart. The study will look at images from patients treated between 2009 and 2012, and will also involve new patients starting from 2013 onwards. There are no additional visits, medication, or follow-up directly because of this study.

Potential risks and benefits

There are no additional benefits or risks to you from taking part in this study, as it uses information from imaging you would already have done as part of your standard care before a TAVI procedure. The injections and scans are routine steps for preparing for TAVI. The aim of the study is to improve the TAVI procedure for future patients by finding the best imaging techniques. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf
Verified postcode
Düsseldorf, Germany· Recruiting

Common questions

What is aortic stenosis?

Aortic stenosis is a condition where the main valve in your heart (the aortic valve) becomes stiff and doesn't open fully, making it harder for blood to leave your heart.

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a procedure to replace a faulty aortic valve using a thin tube, without needing open-heart surgery.

Why do doctors need special pictures before TAVI?

Clear pictures of your heart's main artery and valve help doctors choose the correct size of new valve and plan the TAVI procedure carefully to avoid complications.

Will I have to do anything differently if I join this study?

No, you won't. The study uses information from the scans you would already have as part of your standard preparation for a TAVI procedure.

Will taking part benefit me directly?

Taking part won't directly change your care or give you extra benefits, but the information learned from this study can help improve TAVI procedures for other patients in the future.

How to find out more

Malte Kelm, MD

ctsu@med.uni-duesseldorf.de 0049 211 81 18800 Official trial record

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