About the study

Transcatheter Aortic Valve Implantation is a procedure used to treat aortic stenosis, a condition where the aortic valve becomes narrow and stiff. During a TAVI procedure, debris is released into the bloodstream which can block the arteries that supply the brain and cause a stroke.

Cerebral embolic protection (CEP) devices act like a small filter and have been proven to capture debris before it reaches the brain. The Sentinel device is a CEP device manufactured by Boston Scientific and is approved for use in Europe and USA.

The BHF PROTECT-TAVI trial is a multi-centre, randomised controlled trial to evaluate whether the routine use of the Sentinel CEP device reduces the risk of stroke in patients undergoing TAVI. Between October 2020 and October 2024, 7635 patients were enrolled in the trial across 33 TAVI centres in the UK. Participants were randomised to have either TAVI with the Sentinel CEP device or to have TAVI without the CEP device.

The primary results of the BHF PROTECT-TAVI trial have been published in The New England Journal of Medicine.

Investigators

See our full list of all investigators who contributed to the BHF PROTECT-TAVI trial.