A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis
A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis
Countries participating on the trial
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Aortic stenosis (AS), is a common condition in which one of the four heart valves narrows over many years. When a valve becomes narrow, it can reduce the flow of blood through the heart and the body. Symptoms can include shortness of breath and chest pain; these can take years to develop and some patients never develop symptoms at all. Patients who do have symptoms can have the valve replaced. This works really well, but as with any medical procedure, there is a chance of complications, and it can take a long time to recover. Some heart specialists believe that replacing the valve before symptoms develop may be better than the more conventional approach of performing the AVR once symptoms develop.
This international study is investigating whether it is better for patients with severe AS but no symptoms to have AVR straight away or to wait until symptoms develop before this is done. The results will also tell us which option is more cost effective for the health service because at present we do not know.
It is important to note that this trial is not looking at the difference between having an AVR or TAVI procedure. The intervention you will receive will be at the clinical teams discretion and what they believe is the best option for you. This trial is simply looking at whether there is a difference if a participant has an intervention before symptom development or, as is current practice, to wait for symptoms before having surgery.
The trial is expected to recruit until 30th September 2027 with the trial end date to be March 2031.
This is a short video about the condition - Aortic Stenosis
The trial first opened in the United Kingdom, Australia and New Zealand. Each country has its own protocol, sponsor and funding body.
United Kingdom - British Heart Foundation
Australia - Medical Research Future Fund
New Zealand - Heart Foundation
Central Clinical Trial Team - UK
Chief Investigator: Professor Gerry McCann
Head of Trial Management: Carla Richardson
Senior Trial Manager: Yvette Walters
Senior Statistician: Shaun Barber
Database Development Manager: Theresia Bonsell
Clinical Research Fellow: Dr Ronald Manorekang
Trial Coordinator: Emmanuella Adom-Frimpong
Trial Administrator: Akash Chauhan
Central Clinical Trial Team - Australia
Chief Investigator: Professor Graham Hillis
Clinical Trial Manager: Thomas Gilbert
Central Clinical Trial Team - New Zealand
Clinical Lead: Professor Ralph Stewart
Clinical Trial Coordinator: Danica Kistanna
United Kingdom
easyas@leicester.ac.uk
Leicester Clinical Trials Unit | College of Life Sciences | University of Leicester
Maurice Shock Building
University Road
Leicester
LE1 7RH
Australia
easyas@uwa.edu.au
University of Western Australia
Medical Research Foundation Building
50 Murray St
Perth,
WA 6163
New Zealand
TeWhatuOra.govt.nz
Cardiovascular Research Unit | Te Toka Tumai
Level 3, Building 32,
Park Road, Grafton,
Private Bag 92024,
Auckland 1142
Te Whatu Ora – Health New Zealand