RecruitingNAINTERVENTIONAL

Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation

This study is testing a new device called the SATURN system, which helps fix a leaky heart valve (mitral regurgitation) in people with heart failure. Instead of open-heart surgery, this device is put in using a thin tube (catheter). The main goal is to find out if this new method is practical, safe, and works well to reduce the leak in the heart valve at 30 days. It's for adults aged 65 or older who have symptoms and are considered too high-risk for standard heart surgery. Researchers will follow up to see how participants are doing in the long term. This trial hopes to offer a new treatment option for a serious heart condition.

At a glance

Status

Recruiting

Phase

Sponsor

InnovHeart

Enrolment target

Start

04 Apr 2024

Estimated completion

01 Feb 2030

Heart Failure

What is this study about?

This study is looking at a new way to treat a common heart problem called mitral regurgitation, which is when one of your heart's valves doesn't close properly and lets blood leak backward. This can make your heart work harder and lead to symptoms like breathlessness and tiredness, often linked to heart failure.

The new treatment being tested uses a device called the SATURN system. Instead of traditional open-heart surgery, which involves opening up the chest, this device is put into your heart using a thin tube (catheter) that's guided through a blood vessel. This approach is less invasive than open surgery. The main aim is to see if this new method is practical to use, safe for patients, and whether it effectively reduces the leak in the heart valve.

This trial is specifically for people where open-heart surgery might be too risky due to their age or other health conditions. If this new system proves to be safe and effective, it could offer a valuable alternative for many patients who currently have limited treatment options for their leaky heart valve. Researchers will carefully check how well the device works and whether it causes any problems.

Key takeaways

New treatment for a leaky heart valve.
Uses a less invasive catheter-based approach.
Aimed at people where open-heart surgery is too risky.
Studies if the new device is safe and works well.
Includes various tests to monitor heart health.

Who may be eligible?

This study is looking for volunteers who are 65 years old or older. You should have a leaky heart valve that causes noticeable symptoms like breathlessness, and your doctors must have decided that traditional open-heart surgery would be too risky for you.

Some things that would prevent you from joining include having a different type of heart valve problem, a very short life expectancy for other health reasons, serious infections, or certain other heart conditions. If you need special life support machines or have certain blood disorders, you also wouldn't be able to take part.

Ultimately, a team of heart specialists will decide if this study is the right fit for you based on your overall health and heart condition.

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 65 years old or older?
Do you have a leaky heart valve causing symptoms?
Has your doctor said you're too high-risk for open-heart surgery?
Are you able to take blood-thinning medication?
Are you willing and able to attend study appointments and complete questionnaires?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several tests before and after the main procedure. These include walking tests to check your fitness, answering questionnaires about your quality of life, blood tests, and scans like CT scans and heart scans (echocardiograms) to get detailed pictures of your heart. You'll also have a standard ECG test to check your heart's electrical activity.

The main part of the study is the procedure itself, where the new heart valve device will be implanted using a catheter. This involves placing thin tubes into blood vessels to reach your heart and do some measurements. You will also have additional follow-up appointments and evaluations to monitor your health and how well the device is working.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a novel treatment for your heart condition that may improve your symptoms if it works. However, there are potential risks associated with any medical procedure, including bleeding, infection, and complications related to the device or the implantation process. You will be closely monitored, and your care team will explain all potential side effects. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Tbilisi Heart and Vascular Clinic
Verified postcode
Tbilisi, Georgia· Recruiting
Tbilisi Heart Center
Verified postcode
Tbilisi, Georgia· Recruiting
Ospedale San Raffaele
Verified postcode
Milan, Italy· Recruiting
Instituto Clinico Humanitas
Verified postcode
Milan, Italy· Recruiting
Vilnius University Hospital Santaros Klinikos
Verified postcode
Vilnius, Lithuania· Recruiting
Górnośląskie Centrum Medyczne
Verified postcode
Katowice, Poland· Recruiting
Warsaw Medical University
Verified postcode
Warsaw, Poland· Recruiting
Royal Sussex County Hospital
Verified postcode
Brighton, United Kingdom· Recruiting

Common questions

What is 'mitral regurgitation'?

It's when one of the heart's valves (the mitral valve) doesn't close completely, causing blood to leak backward into the heart. This makes your heart work harder.

What does 'transcatheter approach' mean?

It means the new heart valve is put into your heart using a thin, flexible tube (catheter) guided through a blood vessel, rather than through open-heart surgery.

Why is this study for people who can't have open-heart surgery?

For some people, traditional open-heart surgery is too risky due to age or other health problems. This study is exploring a less invasive option for them.

How long will I be involved in the study?

The study looks at results at 30 days, but also aims to follow up with participants long-term to check the safety and performance of the device.

Will I have to pay to be in the study?

Clinical trials generally cover the costs of study-related treatments and tests. You should discuss any potential personal costs, like travel, with the study team.

How to find out more

VP, Clinical Affairs InnovHeart

a.roach@innovheart.com +49 69 24003626 Official trial record

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