RecruitingNAINTERVENTIONAL

DragonFly EU Pivotal Study

This research study is investigating a new device called the DragonFly Transcatheter Mitral Valve Repair System. It's designed to help people with a common heart problem called mitral valve insufficiency, where the heart's mitral valve leaks, causing symptoms like breathlessness and tiredness. The study is specifically for individuals whose symptoms are severe and who are considered too high-risk for open-heart surgery. It also includes people with a different type of mitral valve leak (functional mitral regurgitation) whose symptoms haven't improved with other treatments. The main goal is to check if the DragonFly device is safe and works well to improve symptoms and heart function. Patients will be followed for up to five years to see the long-term effects.

At a glance

Status

Recruiting

Phase

Sponsor

Hangzhou Valgen Medtech Co., Ltd

Enrolment target

168

Start

01 Jan 2024

Estimated completion

01 May 2029

Mitral Valve Insufficiency

What is this study about?

This study is looking at a new way to treat a common heart problem called mitral valve insufficiency. This happens when one of your heart's valves, the mitral valve, doesn't close properly, causing blood to leak backwards. This can make your heart work harder and lead to symptoms like shortness of breath, tiredness, and swelling.

Traditional treatment often involves open-heart surgery to repair or replace the valve. However, for some people, surgery is too risky because of their age, other health conditions, or the severity of their heart disease. This study is testing a new device, called the DragonFly Transcatheter Mitral Valve Repair System, which aims to fix the leaky valve without the need for major surgery. Instead, it's inserted using thin tubes (catheters) through a vein in your leg, a much less invasive procedure.

The study wants to find out if the DragonFly device is both safe and effective for people who have severe symptoms from a leaky mitral valve and cannot have traditional surgery. It's also for people with another type of leak called functional mitral regurgitation, whose symptoms haven't improved with standard medical care. Understanding if this new approach can help improve their quality of life and heart health is the key aim.

Key takeaways

This study is testing a new, less invasive way to fix leaky heart valves.
It's for people who have severe symptoms and can't have traditional open-heart surgery.
The DragonFly device is put in using thin tubes through your leg, not open surgery.
Patients will be carefully monitored for up to five years after the procedure.
The goal is to see if this new treatment is safe and effectively improves symptoms.
Participation is voluntary, and you can opt out at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and experiencing moderate to severe symptoms from your leaky mitral valve. The study is looking for two main groups of people: those with a specific type of leaky valve called degenerative mitral regurgitation who are considered too risky for open-heart surgery, and those with another type of leaky valve called functional mitral regurgitation whose symptoms haven't improved despite other treatments.

Your heart care team, including a heart surgeon and a cardiologist, would need to confirm that this type of treatment is suitable for you. They would also check if the procedure can be safely performed using the access points needed (for example, through a vein in your leg).

There are also some reasons why you wouldn't be able to join. For example, if you have certain other serious heart conditions, have recently had a heart attack or stroke, or have active infections in your heart. They would also check that the device can be placed properly based on images of your heart.

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 at least 18 years old?
Do you have moderate to severe symptoms from a leaky mitral valve?
Has your doctor told you that open-heart surgery is too risky for you?
Have your symptoms from a leaky valve not improved with other treatments (for some types of leaks)?
Do you not have other serious heart problems like active infections or a very recent heart attack or stroke?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your medical team will first explain the study in detail and ask you to sign a consent form. You will then have the DragonFly device implanted during a procedure that doesn't involve open-heart surgery. After the procedure, you will be carefully monitored before you leave the hospital.

Following your discharge, you'll have several follow-up appointments. These will happen at 30 days, 6 months, and then once a year for up to five years. During these visits, the medical team will check how you're doing, assess your symptoms, and perform tests like ultrasounds of your heart to see how the device is working and if your condition has improved. They will be looking at how well the DragonFly device is repairing your valve and if it's helping with your heart symptoms.

Potential risks and benefits

Participating in this study could offer you the benefit of receiving a new treatment that might improve your heart valve function and reduce your symptoms, potentially leading to a better quality of life, especially if traditional surgery isn't an option for you. Like any medical procedure, there are potential risks, including those associated with inserting the device, such as bleeding, infection, or issues with the heart. Your medical team will explain all potential risks in detail. It’s important to remember that joining a study is always voluntary, and you are free to withdraw at any time without affecting your future medical care.

Locations (1)

Universitatsklinikum Bonn Medizinische Klinik und Poliklinik
Verified postcode
Bonn, Germany· Recruiting

Common questions

What is 'mitral valve insufficiency'?

It means your heart's mitral valve isn't closing properly, letting some blood leak backwards instead of flowing forward.

Why is this treatment different from surgery?

This new treatment uses a device inserted through a vein, meaning it's less invasive than open-heart surgery to repair your valve.

Who is this study for?

It's for people with severe symptoms from a leaky mitral valve who can't have traditional surgery, or whose symptoms haven't improved with other treatments.

How long will I be followed up if I join?

You will have regular check-ups for up to five years after the device is implanted to see how you are doing.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Shuangjie Li

shuangjie.li@valgenmed.com +8617756106609 Official trial record

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