Aortic stenosis is a narrowing of the valve through which blood flows as it leaves the heart, and affects 13% of people over the age of 70 years. The only effective conventional treatment is surgical replacement of the valve, which involves open chest surgery and temporarily stopping the heart, with use of a heart-lung machine. Surgical results are generally excellent but the elderly often have other medical problems that may result in an increased risk of death and complications. Transcatheter Aortic Valve Implantation (TAVI) is a recently developed technique to implant an artificial aortic valve without major surgery, using a catheter to deliver the valve to the heart through the arteries, which are usually accessed by puncturing the skin in the groin.
UK TAVI is a multi-centre randomised controlled trial, funded by the NIHR HTA Programme. The UK TAVI trial will assess the clinical effectiveness and cost-utility of TAVI, compared with conventional surgical aortic valve replacement, in patients with severe symptomatic aortic stenosis, who are at intermediate or high operative risk.
UK TAVI closed to recruitment in April 2018 with 913 participants randomised.
The primary outcome is all cause mortality at 1 year with participants followed up to 5 years post randomisation.
The trial is led by Prof William Toff based at the University of Leicester.
For more information please see the UK TAVI Study Website