RecruitingNAINTERVENTIONAL

Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk

This study is looking at a new heart valve treatment for a common heart problem called mitral regurgitation. This happens when the heart's mitral valve doesn't close properly, causing blood to leak backward. The study specifically focuses on a new valve, the HighLife 28mm Trans-septal Trans-catheter Mitral Valve. It's designed for people whose mitral regurgitation is moderate-severe or severe, and who are considered too unwell or at too high a risk for standard open-heart surgery. Researchers want to make sure this new way of putting in a valve is safe and effective in improving their heart health and quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

HighLife SAS

Enrolment target

120

Start

28 May 2019

Estimated completion

15 Dec 2031

Mitral Regurgitation

What is this study about?

You might have been told you have something called mitral regurgitation. This means one of the valves in your heart, called the mitral valve, isn't working as well as it should. Instead of closing tightly, it leaks, allowing blood to flow backward when your heart beats. This can make your heart work harder and lead to symptoms like breathlessness or tiredness.

Traditionally, these problems might be fixed with open-heart surgery. However, for some individuals, open-heart surgery carries too many risks because of other health conditions or their general health. This study is exploring a new, less invasive way to treat mitral regurgitation using a device called the HighLife 28mm Trans-septal Trans-catheter Mitral Valve. It's designed to be put in without major open-heart surgery, potentially offering an option for those who can't have the traditional operation.

The main goal of this study is to carefully check if the HighLife valve is safe and if it effectively helps people with moderate-severe or severe mitral regurgitation. By taking part, you would be helping doctors understand if this new treatment could become a good option for others in the future.

Key takeaways

The study tests a new heart valve for leaky mitral valves.
It's for people who can't safely have open-heart surgery.
The new valve is put in using a less invasive approach.
The aim is to check if it's safe and helps improve heart health.
Participation could offer a new treatment option and help others.
You'll have regular follow-up appointments if you join.

Who may be eligible?

To join this study, generally, you need to be at least 18 years old and have been diagnosed with moderate-severe or severe mitral regurgitation. Your heart should be causing symptoms like breathlessness or fatigue, even though you're already receiving the best medical care for your condition. A team of heart specialists must agree that open-heart surgery would be too risky for you, and that your heart's structure is suitable for this specific new valve.

There are also some reasons why you might not be able to join. For example, if you've had a stroke or a mini-stroke recently (within the last month), or if you have severe narrowing of the arteries in your neck. Other reasons include active infections, recent stomach bleeding, or problems with blood clotting. You also can't take part if you're pregnant, breastfeeding, or planning to get pregnant soon, or if you can't have certain medical scans or take blood-thinning medicines. Your overall health and ability to attend follow-up appointments are also considered.

Quick self-check

Are you 18 years old or older?
Has your doctor told you that you have moderate-severe or severe mitral regurgitation?
Does a heart specialist team think open-heart surgery would be too risky for you?
Are you receiving the best current medical care for your heart condition?
Are you able to attend all follow-up appointments and assessments?
Have you had a stroke or mini-stroke recently (within the last 30 days)?

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

What does participation involve?

If you decide to take part, you would receive the HighLife heart valve as the main treatment in the study. After the procedure, you'll have regular check-ups to see how you're doing and how the new valve is working. These visits will likely involve physical exams, blood tests, and scans of your heart. You'll need to follow a schedule of appointments for a set period, and it's important that you're able to attend all of these. The exact number of visits and the full length of the study will be explained in detail by the study team.

Potential risks and benefits

Every medical treatment has potential benefits and risks. For this study, a potential benefit is that the HighLife valve could improve your heart function and reduce your symptoms without needing open-heart surgery, offering a treatment option when others aren't suitable. However, as with any medical procedure, there are risks, which the study team will explain fully. These might include risks related to the procedure itself, or side effects from the device or medications. You will be closely monitored, and your safety is the priority. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (50)

St. Vincent's Hospital - Sydney
Darlinghurst, Australia· Recruiting
John Hunter Hospital
Newcastle, Australia· Recruiting
Macquarie University Hospital
Sydney, Australia· Withdrawn
The Wesley Hospital
Auchenflower, Australia· Recruiting
St. Andrew's Hospital
Adelaide, Australia· Recruiting
Princess Alexandra Hospital
Brisbane, Australia· Recruiting
Warringal Hospital
Heidelberg, Australia· Terminated
The Alfred Hospital
Melbourne, Australia· Recruiting
John Hunter Hospital
Newcastle, Australia· Recruiting
Mount Hospital
Perth, Australia· Recruiting
North Shore Private Hospital
Sydney, Australia· Recruiting
ZNA Middelheim
Antwerp, Belgium· Recruiting

+38 more sites — see the official record for the full list.

Common questions

What is mitral regurgitation?

It's a heart condition where one of your heart valves (the mitral valve) doesn't close properly, causing blood to leak backwards in your heart.

Why is this study important?

It's important because it's looking for a new, less invasive treatment option for people with severe mitral regurgitation who are too high-risk for traditional open-heart surgery.

Is the HighLife valve already approved for use?

This is a study to evaluate its safety and effectiveness, meaning it's not yet widely available or approved for routine use outside of clinical trials.

What if I get worse during the study?

You will be closely monitored by a medical team, and your safety is their priority. They will provide appropriate medical care if your condition changes.

Will I have to pay to be in the study?

Clinical trials generally cover the costs of the treatment being studied and study-related visits. This will be confirmed by the study team.

How to find out more

Martin Rothman, MD

MRothman@highlifemed.com +1 707 2177167 Official trial record

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