Active not recruitingNAINTERVENTIONAL

SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

The SMART Trial is looking into how well two different types of replacement heart valves work for people with a condition called severe aortic stenosis. This condition means the main valve in your heart (aortic valve) has become stiff and doesn't open properly, making your heart work harder. Doctors will compare a self-expanding valve with a balloon-expandable valve in patients who have a smaller-than-average opening for their heart valve. The aim is to see which type of valve is safer and performs better over time, especially considering how they work during exercise. This information will help doctors choose the best treatment for similar patients in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

1,103

Start

02 Apr 2021

Estimated completion

01 Dec 2027

Symptomatic Aortic Stenosis Aortic Valve Stenosis Aortic Valve Replacement

What is this study about?

When the main valve in your heart, called the aortic valve, becomes stiff and doesn't open fully, it's known as severe aortic stenosis. This can make your heart work much harder to pump blood around your body, leading to symptoms like breathlessness or chest pain. Often, the best solution is to replace this faulty valve. Advancements in medicine mean this can sometimes be done without major open-heart surgery, using a procedure called Transcatheter Aortic Valve Replacement (TAVR).

There are different types of replacement valves, and this study, called the SMART Trial, is specifically comparing two main kinds: one that expands on its own (self-expanding) and another that is expanded with a small balloon (balloon-expandable). The focus is on patients who have a smaller natural opening for their heart valve, as choosing the right valve for these cases is particularly important. Doctors want to understand which type of valve offers better safety and performance, meaning it works well and causes fewer problems over time.

As part of this trial, some participants will also take part in a small extra study involving an 'exercise stress echocardiogram'. This test helps doctors see how the new heart valve performs when your heart is working harder, like during exercise. By looking at these details, the researchers hope to gather valuable information to help doctors make the best decisions for future patients needing a new aortic valve, especially those with smaller valve openings.

Key takeaways

This study compares two types of heart valve replacements for severe aortic stenosis.
It focuses on patients with smaller heart valve openings.
Participants will be randomly assigned to receive either a self-expanding or balloon-expandable valve.
Follow-up appointments will be required for up to five years.
The study aims to find out which valve is safer and performs better over time.

Who may be eligible?

To be considered for the SMART Trial, potential participants must have severe aortic stenosis and be experiencing symptoms. A team of heart specialists will decide if replacing your heart valve using the TAVR procedure is a suitable option for you and that your risk from the procedure is not too high. Your heart valve opening must also be considered 'small' based on special scans.

Crucially, your heart structure must be suitable for both types of valves being tested in the study, and the procedure must be possible through a vein in your leg. It's also important that you are able and willing to attend all follow-up appointments required by the study over several years.

There are also reasons why someone might not be able to join. These include having a very short life expectancy, severe coronary artery disease that isn't being treated, needing emergency surgery for another reason, or being enrolled in another medical study that could affect these results. Certain medical conditions, being pregnant or planning pregnancy, or having an active COVID-19 infection would also prevent participation. If you've had an aortic valve replacement before, you wouldn't be able to join this study either.

Quick self-check

Do I have severe aortic stenosis causing symptoms?
Has a heart team said TAVR is an option for me?
Are my heart valve measurements 'small'?
Can I attend regular check-ups for up to 5 years?
Am I generally healthy enough for the procedure (not needing emergency treatment for other things)?
Have I not had a previous aortic valve replacement?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you will have a 50/50 chance of receiving one of the two types of replacement heart valves (self-expanding or balloon-expandable) during your TAVR procedure. You won't get to choose which type you receive. Before and immediately after the procedure, doctors will collect information about your health. You'll then have follow-up appointments: when you leave the hospital, about 30 days later, and then once a year for up to five years. During these visits, doctors will check how you're feeling and how your new valve is working. Some participants at specific locations will also have an extra heart scan during exercise at their 12-month appointment to see how their new valve performs under stress. The total duration of your participation, including follow-up visits, could be up to five years.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new, potentially improved heart valve to treat your severe aortic stenosis, which could improve your symptoms and quality of life. However, like any medical procedure, TAVR carries potential risks, including infection, bleeding, stroke, or problems with the new valve. The study is designed to compare two established types of valves, so you will receive a standard treatment. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (92)

Scripps Memorial Hospital
La Jolla, United States
Cedars Sinai Medical Center
Los Angeles, United States
Sutter Health
San Francisco, United States
Los Robles Hospital and Medical Center
Thousand Oaks, United States
University of Colorado
Aurora, United States
Yale New Haven Hospital
New Haven, United States
WHC Washington MedStar
Washington D.C., United States
Morton Plant Hospital
Clearwater, United States
HealthPark Medical Center
Fort Myers, United States
University of Florida
Gainesville, United States
Mount Sinai Medical Center
Miami Beach, United States
Emory Structural Heart Clinic and Emory University Midtown
Atlanta, United States

+80 more sites — see the official record for the full list.

Common questions

What is aortic stenosis?

Aortic stenosis is a heart condition where the main valve in your heart becomes narrow and stiff, making it harder for blood to flow out to your body.

What is TAVR?

TAVR stands for Transcatheter Aortic Valve Replacement. It's a way to replace a faulty aortic valve using a thin tube inserted through a blood vessel, usually in your leg, without major open-heart surgery.

What's the difference between the two valves in the study?

One type of valve expands on its own once it's in place, while the other type is expanded using a small balloon by the doctor.

Will I know which valve I get?

No, you will be randomly assigned one of the two types of valves. You won't get to choose, and neither will your doctor in the context of the study.

How long will I be involved in the study?

If you join, you could be involved for up to five years, attending regular check-ups to monitor your health and the new valve's performance.