RecruitingNAINTERVENTIONAL

Colibri Transcatheter Aortic Heart Valve System Study

The Colibri TAVI System study is looking into a new way to treat a condition called severe aortic stenosis. This is when the main valve in your heart (the aortic valve) doesn't open properly, making your heart work harder. The study is for people aged 75 or older who have severe aortic stenosis and are considered to be at high risk for traditional open-heart surgery. Doctors will use a new device called the Colibri Transcatheter Aortic Heart Valve System, which is put in place through a blood vessel in the leg, avoiding major surgery. The main goal is to check the safety of this new valve in the first 30 days after it's put in. They will also look at how well the device works and its long-term safety over several years.

At a glance

Status

Recruiting

Phase

Sponsor

Colibri Heart Valve LLC

Enrolment target

Start

15 Sep 2021

Estimated completion

01 Jul 2028

Severe Aortic Stenosis

What is this study about?

Imagine your heart has a very important door that lets blood flow out to your body. If this door, called the aortic valve, becomes stiff and doesn't open fully, your heart has to work much harder to pump blood. This condition is called severe aortic stenosis, and it can cause symptoms like breathlessness, chest pain, and feeling faint.

Traditionally, a big operation was needed to fix this by replacing the valve. However, for some individuals, especially those who are older or have other health concerns, this surgery can be very risky. That's where treatments like the one in this study come in. This study is testing a new replacement valve called the Colibri Transcatheter Aortic Heart Valve System. Instead of open-heart surgery, this new valve is delivered to your heart through a small tube inserted into a blood vessel, usually in your leg. This less invasive approach is often called TAVI (Transcatheter Aortic Valve Implantation).

The purpose of this study is to carefully examine how safe and effective the Colibri TAVI System is for people with severe aortic stenosis who are considered to be at high risk for traditional surgery. Doctors will be looking at important health outcomes, particularly in the first month after the procedure. They will then continue to follow participants for several years to understand the long-term benefits and any potential challenges with this new valve.

Key takeaways

Tests a new less invasive heart valve (Colibri TAVI System).
Aimed at people over 75 with severe aortic stenosis.
For patients considered high-risk for open-heart surgery.
Valve inserted through a blood vessel, usually in the leg.
Checks safety and how well the valve works over 5 years.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is for people who are 75 or older and have a severe narrowing of their heart's main valve (aortic stenosis). You would also need to have symptoms from this condition, such as shortness of breath, and your doctors would agree that open-heart surgery to replace the valve would be too risky for you. Your body's measurements, especially around your heart and blood vessels, would need to fit the requirements for this specific device.

There are also reasons why someone might not be able to join. For example, if the blood vessels in your leg aren't suitable for inserting the special tube, or if you have certain other heart conditions or very severe problems with other heart valves. Also, if you've already had a heart valve implanted before, you wouldn't be able to participate. Your doctors will review all these factors carefully.

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.

Am I 75 years old or older?
Have I been diagnosed with severe narrowing of my main heart valve (aortic stenosis)?
Do I have symptoms like breathlessness or chest pain because of my heart valve problem?
Have my doctors said that open-heart surgery would be too risky for me?
Am I willing to have follow-up appointments for up to 5 years?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the Colibri TAVI System to replace your narrowed aortic valve. Doctors would closely monitor your health for at least 30 days after the procedure. After that, you would have follow-up visits and health checks at 6 months, 12 months, and then annually for up to 5 years. These checks would involve various tests to see how well the new valve is working and to monitor your overall health. The specific tests would be explained to you, but typically include examinations, blood tests, and heart scans. The total duration of your participation in the study, including all follow-ups, could be up to 5 years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, less invasive treatment for severe aortic stenosis if you are at high risk for traditional surgery. However, as with any medical procedure, there are potential risks, including those related to the implantation of the valve, such as bleeding, infection, or complications with the heart. Your doctors will discuss all known potential risks and side effects with you in detail. Remember, joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without affecting your future medical care.

Locations (5)

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

Institut Coeur Poumon, CHRU
Verified postcode
Lille, France· Recruiting
Hôpital Privé Jacques Cartier
Verified postcode
Massy, France· Recruiting
Clinique Pasteur
Verified postcode
Toulouse, France· Recruiting
Brighton & Sussex University Hospital, Roayl Sussex County Hospital
Verified postcode
Brighton, United Kingdom· Recruiting
Barts Heart Centre / St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is severe aortic stenosis?

It's a condition where the main valve in your heart that lets blood leave to your body becomes stiff and doesn't open properly, making your heart work harder.

What does TAVI mean?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a way to replace your heart valve without major open-heart surgery, often by going through a blood vessel in your leg.

Who is this study for?

This study is for people aged 75 or older with severe aortic stenosis who are considered too sick or at high risk for traditional open-heart surgery.

How long will I be followed in the study?

You will be followed for at least 30 days after the procedure, and then have check-ups for up to 5 years to monitor your health and the new valve.

Can I leave the study at any time?

Yes, your participation is completely voluntary, and you can choose to leave the study at any point, and it won't affect your future medical care.

How to find out more

R David Fish, MD

colibriTAVI@colibrihv.com 1 (303) 460 8667 Official trial record

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