RecruitingOBSERVATIONAL

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System

This study is checking how effective a special medical device, the NeoChord Artificial Chordae System, is for people who have a heart problem called mitral valve disease. This condition can make your heart valve leaky, tiring you out. The device helps fix this leak. Researchers are following patients who have already received this treatment since late 2016 to see how they are doing up to five years later. They want to understand the long-term results of using this system in real-world healthcare settings. This helps doctors know more about the best ways to treat this condition and improve patients' lives, without asking patients to have extra tests beyond what's usually needed for their treatment.

At a glance

Status

Recruiting

Sponsor

NeoChord

Enrolment target

500

Start

09 Feb 2020

Estimated completion

01 Dec 2027

Mitral Regurgitation Mitral Valve Disease Mitral Valve Insufficiency Mitral Valve Prolapse Heart Valve Diseases

What is this study about?

Imagine your heart has a set of doors, called valves, that open and close to let blood flow through. The mitral valve is one of these doors. Sometimes, this door can become leaky, a condition known as mitral regurgitation or mitral valve disease. This leak means your heart has to work harder, which can make you feel tired or breathless. The NeoChord Artificial Chordae System is a special device designed to help fix this leaky valve, making it work better.

This study is basically checking in on people who have already had the NeoChord device fitted. It's like watching how a new type of repair holds up over a long time, specifically five years. The researchers want to learn about the long-term success of this treatment in real patients, rather than in a special trial setting. This information is really important because it helps doctors understand how well the device works over many years and who benefits most from it.

The main goal is to improve treatments for people with leaky mitral valves. By understanding the long-term outcomes, doctors can make better decisions about care and hopefully improve the health and quality of life for many patients. You won't be asked to have any extra medical procedures for this study that you wouldn't already have as part of your standard care.

Key takeaways

This study tracks the long-term results of a heart valve repair device.
It helps doctors understand how well the NeoChord device works for five years.
Participation means your regular medical information will be used for research.
You won't need any extra tests or appointments to be part of the study.
The findings aim to improve heart care for people with leaky mitral valves.

Who may be eligible?

To be included in this study, patients must have had a moderate to severe leaky mitral valve (doctors call this degenerative or mixed mitral valve regurgitation). Also, their procedure using the NeoChord system must have happened after December 31, 2016. This study is open to both men and women aged 18 and over.

Some conditions might mean you can't be part of this study. For example, if your heart valve is very hardened with calcium, or if it doesn't move well. You also wouldn't be included if you have an active infection in your heart (bacterial endocarditis) or other complex problems with your valve, like a hole in it or if it's too stretched or pulled. Certain types of inflammatory valve disease would also exclude you.

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 I have a leaky mitral heart valve (moderate to severe)?
Was my NeoChord device fitted after December 31, 2016?
Am I 18 years old or older?
Do I have a very hardened (calcified) heart valve?
Do I have an active heart infection?
Are there other complex issues with my valve, like a hole or severe attachment problems?

Answer every question to see your result.

What does participation involve?

Taking part in this study simply means that your doctors will continue to collect information about your health over five years after you've had the NeoChord device fitted. This will involve using details from your regular check-ups and medical records. You won't need extra hospital visits or special tests that aren't already part of your usual care for your heart condition. The information collected will be about how you're recovering, how well the device works for you, and your overall health. Your involvement will just be the collection of this routine information.

Potential risks and benefits

The main benefit of this study is that it helps doctors learn more about the long-term effectiveness of the NeoChord device, which can improve treatment for future patients with similar heart conditions. Since you've already had the procedure, there are no additional medical risks specifically from *participating* in this study, as it only involves gathering information from your routine care. Your personal information will be kept private. You always have the right to decide not to have your information used in the study at any time, and this will not affect the medical care you receive.

Locations (5)

University of Bonn
Verified postcode
Bonn, Germany· Recruiting
CVC Frankfurt
Verified postcode
Frankfurt, Germany· Recruiting
University of Mainz
Verified postcode
Mainz, Germany· Recruiting
Hippokration Hospital
Verified postcode
Athens, Greece· Recruiting
Triemli Hospital
Verified postcode
Zurich, Switzerland· Recruiting

Common questions

What is mitral valve disease?

Mitral valve disease is when one of your heart's main valves (the mitral valve) doesn't close properly, causing blood to leak backward. This can make your heart work harder.

What does the NeoChord device do?

The NeoChord device helps fix a leaky mitral valve by adding new 'cords' to help it close better, reducing the leak.

Will I have extra doctor's appointments for this study?

No, you will not have any extra appointments. The study uses information collected during your normal check-ups and medical care.

How long will information about me be collected?

Information will be collected for up to five years after you had your NeoChord procedure.

Is my personal information kept private?

Yes, all your personal and medical information will be kept confidential and private throughout the study.

How to find out more

Alexandar Jonkers

ajonkers@neochord.com +31 610740977 Official trial record

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