Active not recruitingNAINTERVENTIONAL

Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

This study is looking at a new way to replace a leaky heart valve, specifically the mitral valve, without needing major open-heart surgery. It's called the Neovasc Tiara Mitral Valve System. The study is for people who have severe symptoms because their mitral valve isn't working properly (mitral regurgitation) and are considered too high-risk for traditional surgery. Doctors want to check if this new valve system is safe to use and if it effectively helps people feel better. A small number of patients (up to 30) will take part across different hospitals. The goal is to understand how well the Neovasc Tiara works and if it could become a new option for people needing a mitral valve replacement.

At a glance

Status

Active not recruiting

Phase

Sponsor

Shockwave Medical, Inc.

Enrolment target

Start

01 Dec 2014

Estimated completion

01 Aug 2025

Mitral Valve Regurgitation

Results

Results from this study

Posted May 2021

Results have been published for this study.

Primary outcome

Freedom From All-cause Mortality and Major Adverse Events

Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention

Full results on the registry

What is this study about?

Imagine your heart has a special door, called the mitral valve, that helps blood flow in the right direction. For some people, this door becomes leaky, causing their heart to work much harder. This condition is called mitral valve regurgitation, and it can lead to symptoms like breathlessness or tiredness. Usually, fixing this means having open-heart surgery, which involves opening the chest.

However, for some individuals, open-heart surgery can be too risky, perhaps due to their age or other health problems. This study is exploring a new approach for these patients. It involves a new type of replacement valve called the Neovasc Tiara. Instead of major open-heart surgery, this new valve is put into place using a less invasive method, often through a small incision. This is called a 'transcatheter' procedure because doctors use thin tubes (catheters) to guide the new valve to the heart.

The main purpose of this study is to find out if this new Neovasc Tiara valve system is safe and if it starts to improve the heart's function in people who receive it. It's an "early feasibility" study, meaning it's one of the first steps in testing a new medical device in a small group of patients to make sure it's working as intended before it can be used more widely. The hope is that this new method could offer a safer option for those who can't have traditional surgery.

Key takeaways

This study tests a new heart valve (Neovasc Tiara) for leaky mitral valves.
It's for people who are too high-risk for traditional open-heart surgery.
The new valve is put in using a less invasive method (not open-heart surgery).
The main goals are to check if the new valve is safe and effective.
Participation involves the procedure and follow-up appointments.
You can always choose to leave the study at any time.

Who may be eligible?

To be considered for this study, you would need to have severe leakage of your mitral heart valve (mitral regurgitation) that is causing noticeable symptoms like shortness of breath or fatigue. Importantly, your medical team must have decided that you are at a high risk for traditional open-heart surgery to replace the valve.

You would also need to meet specific requirements about the size and shape of your heart's structures to ensure the new valve can be fitted properly. Your general health must also be suitable for the procedure, meaning you shouldn't be too frail or have other conditions that would make the procedure unsafe, such as being considered for a heart transplant. The study is for adults generally aged 18 and over, and both men and women can participate.

However, you wouldn't be able to join if your doctors believe your leaky valve could be fixed by traditional surgery with a good outcome, or if you have certain heart conditions that make the new valve unsuitable. Also, if you are deemed too unwell or frail for any procedure, you might not be eligible.

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.

Do you have severe symptoms from a leaky mitral heart valve?
Has your doctor told you that open-heart surgery is too risky for you?
Are you generally well enough for a heart procedure, not extremely frail?
Are your heart's measurements suitable for this specific type of valve?
Are you over 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive the Neovasc Tiara mitral valve. This procedure is performed by guiding the new valve to your heart using special tools. After the procedure, you'll have regular check-ups with the study doctors and nurses. These visits will help them monitor how you're recovering and how the new valve is working. They will involve various tests, such as heart scans and general health checks. You won't be given any specific extra medication as part of the study beyond what's normally prescribed for a heart valve replacement. The study will follow your progress for a certain period to gather information on the new valve's long-term performance.

Potential risks and benefits

Potential benefits of taking part could include receiving a new heart valve without the need for major open-heart surgery, which might lead to a faster recovery for some. There's a chance your symptoms could improve, making you feel better. However, as with any medical procedure, there are potential risks, including those associated with heart procedures and anaesthesia. Since this is an early study of a new device, there might be unknown risks. All risks will be discussed in detail with you before you decide to participate. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (10)

Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
Northwestern University
Verified postcode
Chicago, United States
Henry Ford Health System
Verified postcode
Detroit, United States
Washington University
Verified postcode
St Louis, United States
Columbia University Medical Center
Verified postcode
New York, United States
University of Washington Medical Center
Verified postcode
Seattle, United States
ZNA Middelheim
Verified postcode
Antwerp, Belgium
University of Alberta
Verified postcode
Edmonton, Canada
St. Paul's Hospital
Verified postcode
Vancouver, Canada
London Health Sciences Centre
Verified postcode
London, Canada

Common questions

What is mitral valve regurgitation?

It's when the special door (mitral valve) in your heart doesn't close properly, causing blood to leak backward and making your heart work harder.

What does 'high-risk for open chest surgery' mean?

It means your doctors think a traditional surgery where they open your chest would be too dangerous for you, perhaps due to age or other health issues.

Is the Neovasc Tiara valve already approved for everyone?

No, this is an 'early feasibility study,' meaning it's being tested in a small group of patients to check its safety and early performance before wider use.

Will I have to stay in the hospital for a long time?

The hospital stay would be similar to other heart valve procedures that don't involve open-heart surgery, but your doctor will give you more specific details.

Who is paying for this study?

The company that developed the Neovasc Tiara Mitral Valve System, Neovasc, is sponsoring the study.