EASY-AS
Research type
Research Study
Full title
A Randomised Controlled Trial of Early Valve Replacement in severe ASYmptomatic Aortic Stenosis
IRAS ID
266292
Contact name
Gerald McCann
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
This is a major pragmatic multi-centre prospective parallel group open randomised controlled trial. The over-arching aim of the study is to determine whether early aortic valve replacement (AVR) results in better clinical outcomes and cost-effectiveness than a strategy of expectant management in asymptomatic patients with severe aortic stenosis (AS).
Patients with a diagnosis with severe AS will be identified from echocardiogram databases, specialist valve and general cardiology clinics. Potential participants will be provided with a participant information sheet and given at least 24 hours to consider the information.
At the initial assessment, participants’ eligibility criteria will be assessed and informed consent taken by the site Principal Investigator or appropriate delegated qualified individual prior to undertaking any trial-related procedures. Participants will then be randomised to either Group A (aortic valve replacement) or Group B (expectant management). Participants who are randomised to AVR will be investigated and managed according to local protocols and standard practice. Participants will be placed on the waiting list with the expectation that surgery will be performed within three months, dependent on local hospitals waiting lists. Both treatment arms will be followed up for up to three years at 6 months, 12 months, 24 months and 36 months.
The study will be sponsored by the University of Leicester, funded by the British Heart Foundation, coordinated and managed by the Leicester Clinical Trials Unit and supported by the University of Leicester Department of Cardiovascular Sciences.
REC name
Wales REC 1
REC reference
19/WA/0325
Date of REC Opinion
30 Nov 2019
REC opinion
Further Information Favourable Opinion