A clinical trial testing if a device can help reduce the risk of stroke during transcatheter valve replacement for aortic stenosis

British Heart Foundation Randomised Clinical Trial of Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (BHF PROTECT-TAVI)

Aortic stenosis (AS) is a condition causing a narrowing of the aortic valve, restricting blood flow out of the heart. AS can be treated by replacing the damaged valve. This is done either by open heart surgery, or by a less invasive procedure called transcatheter aortic valve implantation (TAVI). During TAVI, a catheter is inserted into a blood vessel and is passed towards the aortic valve. The catheter is used to guide and fix a replacement aortic valve over the top of the damaged valve. While TAVI may be a better option for some people, there is a small risk of stroke associated with the procedure. Material in the artery can be dislodged as the catheter is passed towards the valve – this material can block blood vessels that supply the brain, causing a stroke. Cerebral embolic protection (CEP) devices could reduce the risk of stroke. A CEP device consists of filters inserted into arteries supplying the brain during TAVI to catch any dislodged material. It is not known for certain whether these devices can help prevent strokes. This clinical trial aims to determine if CEP devices reduce the likelihood of stroke during TAVI. The trial will recruit 7730 people undergoing TAVI at hospitals across the UK. Participants will be randomly allocated to either the standard procedure or the procedure with the CEP device. This trial will provide information about the effectiveness and safety of CEP devices and could lead to them being used to help make the TAVI procedure safer.