Active not recruitingNAINTERVENTIONAL

Evolut™ EXPAND TAVR II Pivotal Trial

This research study, called Evolut™ EXPAND TAVR II, is testing a heart valve replacement procedure (TAVR) for people with a heart condition called moderate aortic valve stenosis. This condition means your heart's aortic valve is narrowed, making it harder for blood to flow out to your body. Researchers want to see if using the Medtronic Evolut TAVR systems, along with standard medical care, is safe and works better than just standard medical care alone. The study aims to gather information to help more people with moderate aortic valve stenosis get access to this treatment if it proves beneficial. It's a randomised study, meaning participants will be put into one of two groups by chance.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

650

Start

27 Apr 2022

Estimated completion

01 Dec 2034

Moderate Aortic Valve Stenosis

What is this study about?

This study, called the Evolut™ EXPAND TAVR II Pivotal Trial, is looking into treating a heart condition called moderate aortic valve stenosis. In simple terms, this means the main valve in your heart (the aortic valve) doesn't open as wide as it should, making your heart work harder to pump blood around your body. While this condition can be mild or severe, this study is focusing on people with moderate narrowing who might be experiencing symptoms or have other signs their heart is struggling.

The main aim of this study is to see if a procedure called TAVR (Transcatheter Aortic Valve Replacement) can help people with moderate aortic valve stenosis. TAVR is a way to replace your narrowed heart valve without needing open-heart surgery. Instead, a new valve is guided into place through a small tube usually inserted in your leg. Researchers want to find out if this procedure, combined with the usual medical care, is safe and effective compared to just receiving the usual medical care alone.

By taking part, you would help doctors understand if this less invasive procedure could be a good treatment option for more individuals with moderate aortic valve stenosis in the future. The study is run across many hospitals internationally and will involve groups of people being randomly assigned to either receive the TAVR procedure or continue with their standard medical care.

Key takeaways

Study examines TAVR for moderate aortic valve stenosis.
Compares TAVR with standard medical care.
Aims to expand treatment options for specific patients.
Participants are randomly assigned to treatment groups.
Requires regular follow-up appointments.
Open to individuals aged 65 and over.

Who may be eligible?

To join this study, you need to be at least 65 years old. You must have been diagnosed with moderate aortic valve stenosis, which means your heart's aortic valve is narrowed, but not severely so. Your doctor will use specific measurements from heart scans to confirm this diagnosis.

Crucially, you also need to be experiencing some difficulties because of your heart condition. This could mean you feel out of breath or tired more easily (for example, finding it harder to walk a certain distance), or you've recently been in hospital for heart failure. Other signs that your heart might be under strain, like specific levels of certain substances in your blood or particular findings on your heart scans, could also make you suitable.

However, you cannot join if you are under 65, if your heart is very weak, or if you have certain other specific heart conditions like cardiac amyloidosis. You also wouldn't be able to participate if you have another heart condition that definitely requires open-heart surgery, or if for some reason you can't have a new heart valve fitted.

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?
Have you been told you have 'moderate' narrowing of your heart's aortic valve?
Do you get out of breath, feel tired, or have other symptoms related to your heart condition?
Are you able and willing to attend all study appointments and follow-ups?
Have you been told your heart isn't severely weak (e.g., LVEF not below 20%)?
Do you not have other specific heart issues that would prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of two groups: either you'll have the TAVR procedure using one of the special Medtronic Evolut systems, along with your usual medical care, or you'll receive your usual medical care only. This is done by chance, like flipping a coin, so neither you nor your doctor can choose which group you're in.

Regardless of which group you're in, you'll have regular follow-up visits and assessments with the study team. These visits will involve various tests and checks to monitor your health and the condition of your heart. It's very important that you're willing and able to attend all these scheduled appointments so the researchers can gather all the necessary information. The study will involve ongoing monitoring for a period after you join.

Potential risks and benefits

Taking part in this study could offer you the potential benefit of receiving an advanced heart valve replacement procedure (TAVR) if you are in that group, which might improve your heart function and reduce your symptoms. For those in the standard care group, you might contribute to important scientific understanding without undergoing a procedure. However, as with any medical procedure, there are potential risks associated with TAVR, including those related to the procedure itself, anaesthesia, and recovery. There are also risks and discomforts associated with study visits and tests. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (94)

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

University of Alabama at Birmingham (UAB) Hospital
Verified postcode
Birmingham, United States
Abrazo Arizone Heart Hospital
Verified postcode
Phoenix, United States
HonorHealth Scottsdale Shea Medical Center
Verified postcode
Scottsdale, United States
Los Robles Hospital & Medical Center
Verified postcode
Thousand Oaks, United States
University of Colorado Hospital
Verified postcode
Aurora, United States
Saint Vincents Medical Center
Verified postcode
Bridgeport, United States
Hartford Hospital
Verified postcode
Hartford, United States
MedStar Washington Hospital Center
Verified postcode
Washington D.C., United States
Morton Plant Hospital
Verified postcode
Clearwater, United States
University of Florida
Verified postcode
Gainesville, United States
Saint Vincent's Medical Center Riverside
Verified postcode
Jacksonville, United States
Orlando Health
Verified postcode
Orlando, United States

Common questions

What is moderate aortic valve stenosis?

It's a heart condition where your heart's main valve (aortic valve) is narrowed, making it harder for blood to flow out. 'Moderate' means the narrowing isn't yet severe.

What is TAVR?

TAVR stands for Transcatheter Aortic Valve Replacement. It's a way to replace a narrowed heart valve using a thin tube inserted into a blood vessel, usually in the leg, instead of open-heart surgery.

Why is this study important?

This study aims to find out if the TAVR procedure is a safe and effective treatment option for more people who have moderate, rather than severe, aortic valve stenosis.

Will I definitely get the TAVR procedure if I join?

No, you will be randomly assigned to either receive the TAVR procedure plus standard care, or standard care alone. It's like a lottery.

What does 'guideline-directed management and therapy' (GDMT) mean?

This refers to the standard, recommended medical treatments and care that doctors usually give for your condition, based on current medical guidelines.