RecruitingNAINTERVENTIONAL

PARTNER 3 Trial - Aortic Valve-in-Valve

The PARTNER 3 Trial is investigating a new type of artificial heart valve system called SAPIEN 3/SAPIEN 3 Ultra. This study is specifically for patients in the UK who have a failing artificial valve in their aorta, which is the body's main artery from the heart. The aortic valve helps blood flow correctly. When an artificial valve starts to fail, it means it's not working as well as it should, either by not opening fully (stenosis) or not closing properly (insufficiency). Doctors want to understand how safe and effective the SAPIEN 3/SAPIEN 3 Ultra valve is in replacing these failing valves. The main aim is to see if it can improve patients' health and quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

125

Start

05 Jan 2017

Estimated completion

01 Apr 2038

Aortic Stenosis Aortic Stenosis, Severe

What is this study about?

The PARTNER 3 Trial is a medical study looking into a new way to help people whose artificial heart valve isn't working as well as it should. Your heart has four valves that act like one-way doors, making sure blood flows in the right direction. The aortic valve is very important because it controls blood flow from your heart to the rest of your body.

Sometimes, people have had surgery to replace a faulty aortic valve with an artificial one. Over time, these artificial valves can wear out or become damaged, a condition called a 'failing aortic bioprosthetic valve.' This can make you feel tired, short of breath, or experience chest pain. This study aims to test a new kind of valve, the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV), to see how well it works and if it's safe to use.

This new valve is put in using a less invasive method, often through a small cut in your leg, rather than open-heart surgery. The doctors want to find out if this treatment is a good option for people who have a failing artificial aortic valve. This research is important because it could lead to better and safer treatment choices for patients in the future.

Key takeaways

This study is testing a new artificial heart valve called SAPIEN 3/SAPIEN 3 Ultra.
It's for people whose existing artificial aortic valve isn't working well.
The new valve is put in using a less invasive method than open-heart surgery.
The goal is to check how safe and effective this new treatment is.
Participation involves a procedure and regular follow-up appointments.

Who may be eligible?

To join this study, people generally need to have an artificial valve in their aorta that is not working correctly. This might mean it's too narrow or leaky. The artificial valve also needs to be within a certain size range.

You should also be experiencing symptoms that affect your daily life, such as breathlessness or tiredness, and these need to be at a certain level. Importantly, a team of heart doctors must agree that you are healthy enough for the procedure (low to intermediate risk) and that replacing your failing valve is likely to help you.

However, there are reasons someone might not be able to join. For example, if you have severe problems with other heart valves, or if your failing valve is unstable. If you've recently had a heart attack or another major heart procedure, you might also be excluded. The study also cannot include individuals where the new valve might block other important blood vessels or if the blood vessels leading to your heart are not suitable for the procedure.

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 I have a failing artificial valve in my aorta?
Do these valve problems cause symptoms like breathlessness or tiredness?
Is my Heart Team confident this procedure could help me?
Have I recently (within 30 days) had a major heart attack or another major heart procedure?
Do I have severe problems with any other heart valves?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through checks to see if it's suitable for you. If you are, you will receive the SAPIEN 3/SAPIEN 3 Ultra valve. This procedure is usually done by inserting a tube (catheter) through a blood vessel, typically in your leg, to reach your heart and deploy the new valve. You will stay in hospital for a period after the procedure for recovery and observation.

After leaving the hospital, you will have regular follow-up appointments with your medical team. These appointments will involve check-ups, tests, and scans to monitor your new valve and your overall health. These visits may take place over several years to understand the long-term effects of the valve. The medical team will tell you exactly how many visits you'll need and for how long. You won't be given any experimental medicines; the focus is on the performance of the new valve.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new heart valve that could improve your symptoms and quality of life, using a less invasive procedure than traditional open-heart surgery. However, like any medical procedure, there are potential risks, such as bleeding, infection, complications during the valve placement, or issues with the new valve itself. Your medical team will explain all the potential risks and benefits in detail. It's important to remember that you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (51)

Banner University Medical Center
Verified postcode
Phoenix, United States· Recruiting
University of California Los Angeles
Verified postcode
Los Angeles, United States· Recruiting
Sutter Medical Center
Verified postcode
Sacramento, United States· Recruiting
Kaiser Permanente San Francisco
Verified postcode
San Francisco, United States· Withdrawn
Stanford University Medical Center
Verified postcode
Stanford, United States· Recruiting
UC Health Northern Colorado/Medical Center of the Rockies
Verified postcode
Loveland, United States· Recruiting
Hartford Hospital
Verified postcode
Hartford, United States· Recruiting
JFK Medical Center/ Atlantic Clinical Research Collaborative
Verified postcode
Atlantis, United States· Withdrawn
University of Florida, Gainesville
Verified postcode
Gainesville, United States· Withdrawn
Emory University Hospital
Verified postcode
Atlanta, United States· Recruiting
Northwestern University Hospital
Verified postcode
Chicago, United States· Recruiting
Rush University Medical Center
Verified postcode
Chicago, United States· Recruiting

Common questions

What is 'aortic stenosis'?

Aortic stenosis means your heart's aortic valve has become narrow, making it harder for blood to leave your heart.

What is a 'bioprosthetic valve'?

A bioprosthetic valve is an artificial heart valve made from animal tissue, used to replace a damaged human valve.

What does 'transcatheter heart valve' mean?

It means the new heart valve is put into place using a thin tube (catheter) inserted through a blood vessel, avoiding traditional open-heart surgery.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care is provided free of charge.

What is a 'Heart Team'?

A Heart Team is a group of heart specialists who work together to decide on the best treatment plan for you.

How to find out more

Edwards THV Clinical Affairs

thv_ct.gov@edwards.com (949) 250-2500 Official trial record

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