Active not recruitingNAINTERVENTIONAL

Transcatheter Mitral Valve Replacement System (TMVR) Pilot Study and The Early Feasibility Study of the TMVR Transseptal System

This research is looking at a new treatment for a common heart problem called mitral valve insufficiency, where a heart valve doesn't close properly, causing blood to leak backward. This can make people feel very tired and breathless. The study is testing a new device called the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System. This device is designed to replace the faulty valve using a less invasive procedure than traditional open-heart surgery. The main goals are to see how safe the procedure is and how well the new valve works for people who have severe leaking and are considered high-risk for standard surgery. It's a pilot study, meaning it's one of the first looks at this treatment in people.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

128

Start

01 Apr 2015

Estimated completion

01 Dec 2028

Mitral Valve Insufficiency

What is this study about?

You're reading about a medical study that's exploring a new way to help people with a heart condition called mitral valve insufficiency, or sometimes referred to as 'leaky heart valve'. Imagine your heart has several doors that open and close to keep blood flowing in the right direction. The 'mitral valve' is one of these important doors. If it doesn't close properly, some blood can leak backwards, making your heart work harder and causing symptoms like tiredness and shortness of breath. This condition can become quite serious.

Traditionally, fixing a leaky mitral valve often means open-heart surgery, which is a major operation. For some people, especially those who are older or have other health issues, this surgery can be too risky. This study is testing a new, less invasive procedure. Instead of open surgery, doctors will use a thin tube (called a catheter) to guide a new valve, called the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System, into place. This is done through a small incision, often in the leg, aiming to replace the faulty valve without the need for a large chest incision.

The main purpose of this study is to carefully look at how safe this new procedure is and how well the Intrepid™ device works. The doctors involved want to understand if it can successfully fix the leaking valve and improve the health of patients who might not be able to have traditional surgery. It's an important step in developing new treatment options for a serious heart condition.

Key takeaways

Tests a new, less invasive way to replace a leaky heart valve.
Aimed at people who are high-risk for traditional open-heart surgery.
Uses a special device called the Medtronic Intrepid™ system.
Focuses on the safety and effectiveness of the new procedure.
Could offer improved symptoms for severe mitral valve leakage.

Who may be eligible?

This study is looking for adults aged 18 or older who have a serious leaky heart valve (mitral regurgitation) and are experiencing symptoms. You might be considered if your current symptoms affect your daily life and a team of heart doctors believes that traditional open-heart surgery would be too risky for you.

To be suitable, your heart valve problem needs to be of a certain severity, and importantly, your heart and its surrounding structures must be a good fit for the new device and the way it's put into your body. This means doctors will do special tests to check if the new 'Intrepid' valve can be successfully placed.

However, this study isn't for everyone. You wouldn't be able to join if you have very poor heart function, a blood clot in your heart, or if you've had certain medical events recently, like a stroke within the last few months. Also, if you need other heart surgery or have an infection, this study would not be suitable for you.

Quick self-check

Do you have a serious leaky heart valve and symptoms?
Has your heart team said open-heart surgery is too risky for you?
Are you 18 years old or older?
Do you have a healthy enough heart and no recent major medical events (like a stroke)?
Have doctors confirmed your heart anatomy is suitable for this new device?

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 in this study, you would first undergo careful checks to make sure you're a good fit. If you are, you would then have the new 'Intrepid' mitral valve replacement procedure. This involves the doctors inserting the new valve into your heart, typically by guiding it through a blood vessel from your leg.

After the procedure, the healthcare team will closely monitor you. You'll have regular follow-up appointments, which may include physical examinations, heart scans (like echocardiograms), and blood tests. These visits will help doctors track how well the new valve is working and ensure you're recovering safely. The specific number and timing of these visits will be explained to you, but typically, these studies involve several check-ups over a period to monitor your heart health and the device's performance long-term.

Potential risks and benefits

Taking part in this study could offer you a potential benefit by repairing your leaky heart valve with a less invasive procedure than traditional surgery, which might be a good option if open-heart surgery is too risky for you. This could mean an improvement in your symptoms, such as feeling less breathless and tired. However, like any medical procedure, there are potential risks, including those associated with heart procedures and anaesthesia. There's also a chance the new device may not work as expected, or that you could experience complications. The study team will explain all known risks to you in detail. Remember, you have the right to withdraw from the study at any time without it affecting your future medical care.

Locations (32)

Abrazo Arizona Heart Hospital - EFS
Phoenix, United States
Cedars-Sinai Medical Center - PILOT
Los Angeles, United States
Piedmont Atlanta Hospital - PILOT
Atlanta, United States
Northwestern Memorial Hospital - PILOT
Chicago, United States
University of Michigan Health System - University Hospital - PILOT
Ann Arbor, United States
Corewell Health - EFS
Grand Rapids, United States
Abbott Northwestern Hospital - EFS
Minneapolis, United States
Abbott Northwestern Hospital - PILOT
Minneapolis, United States
Barnes Jewish Hospital - PILOT
St Louis, United States
NYU Langone Medical Center - PILOT
New York, United States
The Mount Sinai Hospital (New York NY) - EFS
New York, United States
The Mount Sinai Hospital (New York NY) - PILOT
New York, United States

+20 more sites — see the official record for the full list.

Common questions

What is mitral valve insufficiency?

It's when one of your heart's valves, called the mitral valve, doesn't close properly, allowing some blood to leak backwards. This makes your heart work harder.

What is the 'Intrepid' system?

It's a new type of artificial heart valve designed to replace a faulty mitral valve without needing major open-heart surgery.

How is the new valve put in?

Doctors guide the new valve into your heart using a thin tube (catheter) through a small incision, often in your leg, rather than a large chest incision.

Why is this study important?

It's exploring a new treatment option for people with serious leaky heart valves who might be too unwell to have traditional open-heart surgery.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating at any time, and it won't affect any future medical care you receive.