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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Other forms of heart disease
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Surgery;
You can take part if:
You may not be able to take part if:
1. Symptoms related to aortic stenosis (AS) 2. Additional severe valvular heart disease 3. Elective cardiac surgery planned before randomisation (e.g. CABG) 4. Left ventricular systolic dysfunction (LVEF < 50%) 5. Pregnancy 6. Co-morbid condition that, in the opinion of the treating cardiologist, limits life expectancy to < 2 years
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Leicester and funded by BRITISH HEART FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 43371
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
