Not yet recruitingOBSERVATIONAL

Circle Method Observational Project - Non-interventional, Retrospective, Multicenter Data Collection

This study is gathering information from past medical records of people in the UK who have a type of heart valve problem called a bicuspid aortic valve. These patients had a keyhole procedure called TAVI (Transcatheter Aortic Valve Implantation) to replace their faulty valve. The researchers are looking at whether using a particular sizing technique, known as the 'circle method,' for the new heart valve led to fewer complications compared to when a different sizing method was used. The main goal is to understand if the 'circle method' helps doctors choose the best size for these replacement valves and to create clear guidance for future use. This is not a new experiment; it's a review of existing information to improve patient care.

At a glance

Status

Not yet recruiting

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrolment target

Start

01 Jun 2025

Estimated completion

01 Aug 2025

Aortic Stenosis With Bicuspid Valve

What is this study about?

You might have heard about a condition called aortic stenosis, where your heart's main valve doesn't open properly. For some people, this valve has two flaps instead of the usual three; this is called a bicuspid aortic valve. Over time, this can lead to severe narrowing, needing treatment.

A procedure called TAVI (Transcatheter Aortic Valve Implantation) is a way to replace a faulty heart valve using a thin tube, rather than open-heart surgery. It's often used for older patients or those who can't have surgery. In the past, people with bicuspid valves were sometimes thought not to be suitable for TAVI, but now, with advances in technology, more patients are having this procedure.

Choosing the correct size for the new heart valve is very important for TAVI to be successful. There are different ways doctors measure for this, and one newer method is called the 'circle method.' This study is looking back at records of patients who have already had a TAVI because of a bicuspid valve. The researchers want to see if using the 'circle method' to size the new valve led to fewer problems for patients. They hope to develop clear advice for doctors on how best to use this method in the future to improve safety and success for TAVI patients.

Key takeaways

Looks at past medical records, no new tests or treatments.
Focuses on patients with a bicuspid aortic valve who had a TAVI procedure.
Investigates a sizing technique called the 'circle method'.
Aims to improve future TAVI procedures by developing better sizing guidelines.
No impact on patients whose data is reviewed.

Who may be eligible?

This study is looking at medical information from people who have already had a specific heart procedure. You could be included in this study if you had a bicuspid aortic valve (meaning your heart valve had two flaps instead of three) and then had a heart valve replacement using a specific type of keyhole procedure, known as TAVI, where a balloon-expandable valve (SAPIEN 3 or Ultra) was used.

Crucially, the hospital must also have detailed CT scans of your heart available from around the time of your procedure. This study doesn't involve any new tests or treatments; it's purely about looking at existing patient data.

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.

Did you have a bicuspid aortic valve?
Did you have a TAVI procedure using a SAPIEN 3 or Ultra valve?
Were detailed CT scans of your heart available for your doctor?
Are your medical records from the UK?

Answer every question to see your result.

What does participation involve?

As this study is looking at records from patients who have already had their heart valve procedure, you would not need to do anything extra or attend any appointments. There are no new tests, medicines, or follow-up visits involved for patients. Your existing medical information, collected during your standard care, would be reviewed by the research team. This means there's no additional time commitment or burden on you.

Potential risks and benefits

Because this study only involves reviewing existing medical records and not any new treatments or tests, there are no direct risks to your health or well-being from participating. The potential benefit is that the findings could help doctors improve the way heart valves are sized for future patients with similar conditions, potentially leading to better outcomes. You have the right to ask for your data not to be included in this historical review at any time, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Papworth Hospital NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom
Golden Jubilee National Hospital
Verified postcode
Clydebank, United Kingdom
Guy's and St Thomas NHS Foundation Trust
Verified postcode
London, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Verified postcode
Worthing, United Kingdom

Common questions

What is a 'bicuspid aortic valve'?

It's when your heart's main valve, the aortic valve, has two flaps instead of the usual three, which can sometimes cause problems.

What is TAVI?

TAVI (Transcatheter Aortic Valve Implantation) is a keyhole procedure to replace a faulty heart valve without major open-heart surgery.

What is the 'circle method'?

It's a special way doctors measure the heart and plan the size of a new valve before a TAVI procedure.

Will I have to do anything if my data is used?

No, this study only looks at existing medical records, so you won't need to do anything extra or attend any appointments.

How will this study help patients?

By understanding which sizing methods work best, doctors can improve future TAVI procedures for patients with bicuspid aortic valves.

How to find out more

Marie F Zielinski

marie.zielinski@ippmed.de +49 4471 850 3326 Official trial record

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