RecruitingNAINTERVENTIONAL

TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics

This study aims to understand how precisely positioning the new valve during a TAVR procedure affects blood flow in the heart and the health of the coronary arteries. TAVR is a key treatment for a common heart valve problem in older adults, and increasingly for younger patients too. Doctors want to make sure these new valves last as long as possible and don't cause problems with important blood vessels. The study also explores whether newer, potentially safer imaging techniques, like certain MRI and ultrasound scans, can provide the same crucial information about valve placement as existing methods, which sometimes involve more radiation. Ultimately, this research hopes to improve TAVR results for thousands of patients.

At a glance

Status

Recruiting

Phase

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

100

Start

22 Oct 2024

Estimated completion

31 Dec 2025

Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Implantation Commissural Alignment Commissural Misalignment Symmetry Prothesis Positioning Prosthesis Durability Aortic Valve Stenosis Aortic Valve Disease

What is this study about?

Imagine your heart has a door, called the aortic valve, that opens and closes to let blood flow out to your body. If this door gets stiff and narrow, it's called aortic valve stenosis, and it makes your heart work much harder. A common treatment for this is called TAVR (Transcatheter Aortic Valve Replacement), where doctors replace the faulty valve with a new one through a small tube, often in the leg, rather than open-heart surgery.

This study focuses on something very important: how the new valve is positioned inside your heart. Doctors want to know if placing the new valve in a very specific way, ensuring it's lined up perfectly and sits symmetrically, makes a difference to how well blood flows through it and whether it affects the smaller blood vessels that feed your heart, called coronary arteries. This is especially important as more and more people, including younger patients, are having TAVR. For these patients, making sure the new valve works well for many years and doesn't block access to other treatments they might need later is crucial.

The research will also look at different ways to take pictures of your heart after the TAVR procedure. Currently, doctors often use a type of X-ray scan called a CT scan to see how the new valve is positioned. This study will see if other types of scans, like special MRI scans or ultrasound scans of your heart, can provide the same detailed information. If they can, these newer methods might be safer or more comfortable for patients by reducing exposure to radiation or contrast dyes. This knowledge will help doctors fine-tune the TAVR procedure to give patients the very best long-term results.

Key takeaways

The study explores how the new heart valve's position after TAVR affects blood flow and other arteries.
It aims to improve the long-term success of TAVR, especially for younger patients.
Researchers are testing if common, safer scans can provide the same information as current X-ray scans.
Participation involves having additional non-invasive heart scans.
This research could help doctors perform TAVR procedures more effectively in the future.

Who may be eligible?

To be considered for this study, you must have already had a TAVR procedure where the new valve was put in through a blood vessel in your leg (known as 'transfemoral'). This is an important starting point for all participants.

However, there are several reasons why you might not be able to join. For example, if your TAVR was done using a different approach (not through the leg), or if you already had a different type of artificial valve put in before, you wouldn't be able to participate. Also, if you have certain existing medical conditions like severe liver problems, issues with your gullet (oesophagus), or problems with blood clotting, you would not be eligible.

The study also cannot include individuals who have a pacemaker or a similar heart device already implanted, or those who have certain brain or mental health conditions, such as dementia or severe alcoholism, that would make it difficult to understand the study or attend appointments.

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.

Have you already had a TAVR procedure?
Was your TAVR done through a blood vessel in your leg?
Do you have a pacemaker or similar heart device?
Do you have severe liver problems or certain swallowing issues?
Do you have any conditions that would make it hard to understand or attend appointments?

Answer every question to see your result.

What does participation involve?

This study is for people who have already had a TAVR procedure. Taking part would involve having additional heart scans to help doctors understand how your new valve is working. Specifically, you would undergo a specialised ultrasound scan of your heart, called a transthoracic echocardiography, which is a common and non-invasive test. The study does not mention any new medications or long-term follow-up beyond the assessments required for the research questions. The exact number of visits or the total duration of your participation is not specified but would likely revolve around one or two assessment appointments.

Potential risks and benefits

The main benefit of taking part is contributing to important medical knowledge that could improve TAVR procedures for future patients, potentially leading to longer-lasting valves and better patient outcomes. As you have already undergone the TAVR procedure, this study primarily involves additional imaging tests. While these scans, like echocardiograms, are generally very safe, there are always minor, rare risks associated with any medical procedure. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Common questions

What does TAVR mean?

TAVR stands for Transcatheter Aortic Valve Replacement. It's a procedure to replace a faulty heart valve without open-heart surgery, often by guiding a new valve through a blood vessel.

Why is valve positioning so important?

Doctors believe how precisely the new valve is positioned can affect blood flow, how long the valve lasts, and if it causes problems with other heart arteries. This study aims to confirm that.

Will I have to take new medicines?

No, this study doesn't involve any new medications. It focuses on taking special scans of your heart.

What is 'commissural alignment'?

It's a medical term for how well the parts of the new artificial valve line up with the original parts of your heart valve. The study is investigating if this alignment matters for blood flow.

Is this study safe?

The study involves standard heart scans like echocardiography, which are generally considered very safe procedures with minimal risks.

How to find out more

Tobias Zeus, Prof

zeus@med.uni-duesseldorf.de 0211 81 18800 Official trial record

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