RecruitingOBSERVATIONAL

Tendyne European Experience Registry

This study, called TENDER, is observing how a new heart valve, the Tendyne Mitral Valve System, is working for people in everyday medical care across Europe. It’s for adults who have a common heart problem called mitral regurgitation, where a valve in the heart leaks. Often, these patients are too unwell or too old for open-heart surgery, so this newer, less invasive system was developed. The study is gathering information on how safe and effective the Tendyne system is for patients over months and years, and also looking at features of the heart that might predict how well the treatment will work. It aims to understand the real-world experience of this new treatment after it has been approved for use.

At a glance

Status

Recruiting

Sponsor

LMU Klinikum

Enrolment target

400

Start

15 Apr 2021

Estimated completion

31 Dec 2027

Mitral Regurgitation

What is this study about?

Heart valve problems are quite common, and one in particular is called mitral regurgitation. This means one of the valves in your heart, the mitral valve, doesn't close properly and lets blood leak backward. If this isn't treated, it can unfortunately lead to serious health issues.

Traditionally, surgery has been the main way to fix a leaky mitral valve. However, for many people, especially those who are older or have other health conditions, open-heart surgery can be too risky. Because of this, new ways to treat mitral regurgitation have been developed that are less invasive, meaning they don't involve a big operation.

One of these newer treatments is called the Tendyne Mitral Valve System. This device is designed to replace your faulty mitral valve without needing open-heart surgery. This study, called TENDER, is carefully watching how the Tendyne system is performing in people who are already receiving it as part of their normal medical care. Researchers want to see if it's safe and effective over time, checking on patients at 30 days, one year, and three years after they get the new valve. They are also looking at specific details of patients' hearts to understand who might benefit most from this treatment.

Key takeaways

This study is about a new heart valve system called Tendyne.
It's for people who have a leaky heart valve (mitral regurgitation).
It looks at how well the Tendyne system works in real patients over 3 years.
Participation means allowing researchers to use your existing medical information.
No extra treatments or visits are needed if you join.
Helps doctors learn to improve future care for patients.

Who may be eligible?

To be part of this study, you would need to be an adult who has already received the Tendyne Mitral Valve System for your mitral valve problem as part of your regular medical treatment. This means the decision to give you the Tendyne system would have been made by your doctors because it was considered the best option for your condition, not specifically for this study.

An important part of joining is that you must be willing to give your written permission to participate. This is called 'informed consent'. It means you've had all the information about the study explained to you, you understand it, and you're happy to allow your medical information to be used for research purposes, while keeping your privacy protected.

If you haven't received the Tendyne system, or if you don't wish to give your written consent to be part of the study, then you wouldn't be able to join. Remember, your doctors will always discuss all your treatment options with you.

Quick self-check

Have I already received the Tendyne Mitral Valve System?
Was the Tendyne treatment part of my standard medical care for a leaky heart valve?
Am I an adult (18 years or older)?
Am I willing to give written permission for my medical information to be used for research?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are already a patient who has received the Tendyne Mitral Valve System, taking part in this study would mainly involve allowing the researchers to collect information from your existing medical records. This includes details about your health before the procedure, during your hospital stay, and from your routine follow-up appointments.

There are no extra visits or special medications required just for this study. The researchers will gather data from your scheduled doctor's appointments and heart checks (like echocardiograms or CT scans) that you would have anyway as part of monitoring your health after getting the Tendyne valve. The study will track your progress for up to three years after your procedure. You will be asked to provide written consent to allow the sharing of your medical information for the study.

Potential risks and benefits

The main benefit of taking part in this study is that it helps doctors learn more about how the Tendyne Mitral Valve System works in real patients. This knowledge can improve care for future patients with similar heart conditions. As this is an observational study, meaning you've already received the treatment as part of your standard care, there are no additional medical risks from the Tendyne device itself beyond what you've already discussed with your doctors. The main risk involves your personal information. However, strict rules are in place to keep your data private and confidential. You are always free to withdraw your consent at any time, which means your information would no longer be used for the study, without affecting your medical care.

Locations (30)

Universitaetsklinikum Linz
Linz, Austria· Recruiting
Universitaetsklinikum Wien
Vienna, Austria· Recruiting
UZ Leuven
Leuven, Belgium· Recruiting
CHU de Bordeaux
Bordeaux, France· Not yet recruiting
CHU de Lille
Lille, France· Recruiting
CHU Rennes
Rennes, France· Not yet recruiting
Clinique Pasteur
Toulouse, France· Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany· Recruiting
Deutsches Herzzentrum Berlin
Berlin, Germany· Recruiting
Universitaetsklinikum Bonn
Bonn, Germany· Recruiting
Universitaetsklinikum Koeln
Cologne, Germany· Recruiting
Universitätsklinikum Frankfurt
Frankfurt, Germany· Recruiting

+18 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

It's a common heart condition where one of your heart valves, the mitral valve, leaks, allowing blood to flow backward.

What is the Tendyne Mitral Valve System?

It's a medical device designed to replace a leaky mitral valve without needing open-heart surgery.

Am I receiving a new treatment if I join this study?

No, if you join, you would have already received the Tendyne system as part of your usual medical treatment, not specifically for the study.

What does 'observational study' mean?

It means researchers are simply observing and collecting information about an already approved treatment in real-world patients, not testing a new, untried treatment.

Will my personal information be kept private?

Yes, strict rules and laws are followed to protect your privacy and keep your medical information confidential within the study.

How to find out more

Joerg Hausleiter, MD

joerg.hausleiter@med.uni-muenchen.de 0049894400 Official trial record

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