British Heart Foundation Randomised Clinical Trial of Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (BHF PROTECT-TAVI)
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
5 years, 11 months, 30 days
Aortic stenosis (AS) is a common life-threatening condition, where blood flow out of the heart is restricted by narrowing of the aortic valve. There are two ways to treat AS. Transcatheter Aortic Valve Implantation (TAVI) insert a new valve inside the existing diseased valve. Surgical aortic valve replacement (AVR) involves surgery on the heart to replace the diseased valve.
TAVI is less invasive than surgical AVR. However, there are still risks with TAVI including stroke and death. Stroke in TAVI can be caused by debris released into the bloodstream by the procedure. Devices, called cerebral embolic protection (CEP), have been developed that capture some of this debris using filters temporarily placed in the artery which provides blood to the brain. However, there is of yet no evidence that shows that CEP meaningfully reduces stroke in TAVI patients. This trial will address this evidence gap.
In this study we will randomly assign patients receiving TAVI to receive CEP during TAVI or to the current standard of care without CEP. Potential participants will be approached prior to their TAVI procedure to discuss the trial. If they are happy to take part, full informed consent will be sought. Following the TAVI, we will assess whether participants have a stroke in the following 72 hours. We will also assess how the CEP treatment impacts on the NHS as well following-up participants for 12 months to assess their long term outcomes. We will recruit 7730 participants across the UK over 4 years.
Wales REC 5
Date of REC Opinion
23 Apr 2020