RecruitingNAINTERVENTIONAL

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

This study, called EASY-AS, is for people over 18 who have severe aortic stenosis but haven't developed any symptoms yet. Aortic stenosis is a common heart condition where the main valve leading out of your heart narrows. Doctors aren't sure whether it's better to treat this condition early with surgery or a keyhole procedure, or to simply watch and wait until symptoms appear. This study aims to find out which approach leads to better health outcomes, like preventing heart problems or needing hospital stays, and how cost-effective each option is. It will compare these two approaches through careful research.

At a glance

Status

Recruiting

Phase

Sponsor

University of Leicester

Enrolment target

2,844

Start

10 Mar 2020

Estimated completion

01 Apr 2031

Aortic Stenosis

What is this study about?

Imagine your heart has a main door, called the aortic valve, that opens to let blood flow to the rest of your body. Sometimes, this door can narrow, a condition called aortic stenosis. This is quite common, especially in older people. For a long time, doctors have typically waited until people start feeling symptoms like chest pain or breathlessness before suggesting treatment. This is because the heart often copes well for a long time without you noticing any problems.

However, some doctors now wonder if treating severe aortic stenosis early, even before symptoms appear, might be better for some people. The problem is, there hasn't been enough research to clearly show whether early treatment or waiting is truly best. This study, called EASY-AS, aims to fill that gap. It's a very important study because it will help doctors understand the best way to look after people with this condition and could change how it's treated in the future.

The main goal is to see if having valve replacement surgery or a keyhole procedure called TAVI earlier, before symptoms develop, can reduce the risk of serious problems like heart failure or even death, compared to simply keeping a close eye on your condition. The study will also look at how cost-effective each approach is for the healthcare system.

Key takeaways

The study investigates early treatment vs. careful monitoring for severe aortic stenosis without symptoms.
It aims to find out which approach leads to better health and is more cost-effective.
Participants will be randomly assigned to either early valve replacement (surgery or TAVI) or regular monitoring.
This research has the potential to guide future medical care for this common heart condition.
Your choice to participate is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 or over. You must have severe aortic stenosis, which is a specific heart valve problem, but crucially, you shouldn't be experiencing any symptoms from it yet. Your doctor must also agree that both early treatment and careful monitoring are suitable options for you.

There are also some specific measurements your heart doctor will look at to confirm you have severe aortic stenosis, sometimes including a calcium score in your heart. You also need to be suitable and well enough for either traditional surgery or the keyhole TAVI procedure, and be willing to be put into one of the two groups (early treatment or monitoring) at random.

You cannot take part if you already have symptoms related to your aortic stenosis, if you have other severe heart valve problems, or if you're already pregnant. Also, if you have other health conditions that doctors believe might shorten your life significantly, you might not be able to join.

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 18 years old or older?
Have you been told you have 'severe aortic stenosis'?
Do you currently have *no symptoms* related to your heart condition?
Are you able and willing to be randomly put into one of the study groups?
Would your heart doctor say you are healthy enough for either valve replacement surgery or TAVI?

Answer every question to see your result.

What does participation involve?

If you join the EASY-AS study, you'll be randomly assigned to one of two groups. One group will be put on a waiting list for early aortic valve replacement (either surgery or a keyhole procedure called TAVI), aiming for the procedure within three months, depending on hospital waiting lists. This might involve routine tests like a coronary angiogram.

The other group will be carefully monitored, which means you'll have regular check-ups and your heart condition will be closely watched. The study is planned to run for a number of years, and your participation will involve regular follow-up appointments and assessments as determined by the study protocol. The full duration of your individual involvement will be explained to you by the study team.

Potential risks and benefits

Potential benefits of taking part could include earlier treatment for your condition, which might reduce future heart problems, or it could help us understand that careful monitoring is just as good, avoiding unnecessary procedures. However, undergoing any medical procedure carries risks, such as those associated with surgery or anaesthesia. Even careful monitoring involves regular appointments and potentially anxiety about your condition. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (110)

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

Canberra Hospital
Verified postcode
Garran, Australia· Recruiting
Liverpool Hospital
Verified postcode
Liverpool, Australia· Recruiting
Royal North Shore Hospital
Verified postcode
St Leonards, Australia· Recruiting
Westmead Hospital
Verified postcode
Westmead, Australia· Recruiting
Wollongong Hospital
Verified postcode
Wollongong, Australia· Recruiting
Prince Charles Hospital
Verified postcode
Chermside, Australia· Recruiting
Townsville Hospital
Verified postcode
Douglas, Australia· Recruiting
The Gold Coast Hospital
Verified postcode
Southport, Australia· Recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Adelaide, Australia· Recruiting
Monash Health
Verified postcode
Clayton, Australia· Recruiting
University Hospital Geelong
Verified postcode
Geelong, Australia· Recruiting

Common questions

What is 'aortic stenosis'?

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

What does 'asymptomatic' mean?

It means you don't have any noticeable symptoms from your condition, even though it's present.

What is 'AVR' and 'TAVI'?

AVR is Aortic Valve Replacement (traditional open-heart surgery to replace the valve). TAVI is Transcatheter Aortic Valve Implantation (a keyhole procedure to replace the valve).

Why is this study needed?

Doctors don't currently know if it's better to treat severe aortic stenosis early, even without symptoms, or to wait until symptoms appear. This study aims to find the answer.

Will I get to choose my treatment?

No, you'll be randomly assigned to either early treatment or careful monitoring, like flipping a coin, to ensure a fair comparison.

How to find out more

Carla Richardson

easyas@leicester.ac.uk +44 0116-229-7936 Official trial record

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