RecruitingOBSERVATIONAL

The ReTAVI Prospective Observational Registry

This study, called "The ReTAVI Prospective Observational Registry," is checking how well a second heart valve replacement works. This is for people who have already had a keyhole heart valve procedure (TAVI) but their first valve isn't working as well as it should. We call this a 'redo-TAVI'. More and more people, including younger patients, are having TAVI procedures. This means more people might need a second one in the future. Currently, we don't have much information on second TAVI procedures. This study aims to gather important details on how safe and effective redo-TAVI is, both in the short-term (30 days) and long-term (up to 5 years). We want to understand which methods work best.

At a glance

Status

Recruiting

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrolment target

250

Start

05 Sep 2023

Estimated completion

01 Dec 2031

Structural Valve Deterioration Structural Valve Degeneration Symptomatic Patients Who Have Had Transcatheter Heart Valve (THV) Failure Prosthetic Valve Malfunction Prosthesis Failure

What is this study about?

Imagine your heart has a special door, called a valve, that helps blood flow in the right direction. Sometimes, this door can get stiff and not open properly, a condition called aortic stenosis. A procedure called TAVI (Transcatheter Aortic Valve Implantation) can replace this old, stiff door with a new, artificial one without open-heart surgery.

Over time, just like any door, the new artificial valve can wear out or stop working perfectly. This study is for people who need a second TAVI procedure because their first replacement valve isn't working as it should. This second procedure is often called a 'redo-TAVI'. Because TAVI is now being offered to more and more people, including those who are younger and otherwise healthier, doctors expect that more people will need a redo-TAVI in the future.

Currently, we don't know a lot about how safe and effective these redo-TAVI procedures are in the long run. This study aims to collect detailed information from many patients having a redo-TAVI. We want to understand how they are doing shortly after the procedure (30 days) and how they are doing years later (up to 5 years). This will help doctors make better decisions about treatment for future patients.

Key takeaways

This study collects real-world data on second TAVI procedures.
It aims to understand long-term outcomes of redo-TAVI.
Participation involves sharing medical information from your standard care.
The goal is to improve future patient care for failing heart valves.
Follow-up appointments are needed for up to 5 years.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) who has had a successful first TAVI procedure, but that first valve is now failing.

You must be planning to have a redo-TAVI procedure using a specific type of valve (SAPIEN family THV). Your heart care team must also agree that this second procedure is suitable for you. You also need to be able to attend follow-up appointments at the hospital 30 days and 12 months after your procedure.

However, you cannot join if you haven't given your permission to take part, or if doctors believe you have less than 12 months to live. Pregnant women cannot participate, and you also won't be able to join if there isn't enough information available about your medical history.

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 18 years old or older?
Have you had a previous TAVI procedure that was successful?
Is your current TAVI valve failing and do you need a redo-TAVI?
Has your heart team decided a redo-TAVI is suitable for you?
Are you able to attend follow-up appointments at 30 days and 12 months?
Are you not currently pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, doctors will collect information about your health before, during, and after your redo-TAVI procedure. This includes details about the procedure itself and how you recover. You will need to attend hospital appointments for follow-up at 30 days and one year after your redo-TAVI. Information will also be collected at three and five years. The total duration of your participation could be up to 5 years, as the study aims to track your health over this period.

Potential risks and benefits

The potential benefit of taking part is that the information gathered from your experience will help doctors understand more about redo-TAVI procedures. This could improve the care for other patients needing a second valve replacement in the future. As with any medical procedure, there are potential risks associated with the redo-TAVI itself, which your doctor will discuss with you. Taking part in the study simply involves collecting information about your usual care. You have the right to withdraw from the study at any time without affecting your medical treatment.

Locations (62)

LKH-University Hospital and Medical University of Graz
Verified postcode
Graz, Austria· Recruiting
Kepler University Clinic Linz
Verified postcode
Linz, Austria· Recruiting
University Hospital St. Pölten
Verified postcode
Sankt Pölten, Austria· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting
Institut Universitaire de Cardiologie et de Pneumologie
Verified postcode
Québec, Canada· Recruiting
St. Paul's Hospital, Vancouver
Verified postcode
Vancouver, Canada· Recruiting
Centre Hospitalier Universitaire de Bordeaux
Verified postcode
Bordeaux, France· Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand
Verified postcode
Clermont-Ferrand, France· Recruiting
Centre Hospitalier Universitaire de Lille
Verified postcode
Lille, France· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
Hôpitaux Universitaires de Marseille Timone
Verified postcode
Marseille, France· Recruiting

Common questions

What is a 'redo-TAVI'?

It's when you have a second keyhole heart valve replacement because your first artificial valve isn't working well anymore.

Why is this study important?

It helps doctors learn more about the safety and effectiveness of these second procedures, especially as more people are having them.

Will I get a special treatment if I join?

No, you will receive the standard redo-TAVI procedure recommended by your heart team. The study only collects information about your treatment and recovery.

How long will I be in the study?

Information will be collected for up to 5 years after your redo-TAVI, with specific follow-up visits at 30 days and 1 year.

Can I change my mind about participating?

Yes, you can withdraw your consent to be part of the study at any time without it affecting your medical care.

How to find out more

Claudia Lüske, PhD

claudia.lueske@ippmed.de 044718503324 Official trial record

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