About the study

In this study we randomly assigned patients receiving TAVI to receive CEP during TAVI or to the current standard of care without CEP. Potential participants were approached prior to their TAVI procedure to discuss the trial. If they were happy to take part, full informed consent was sought. Following the TAVI, we assessed whether participants had a stroke in the following 72 hours. We also assessed other ways the CEP treatment impacts on the NHS as well following-up participants for 12 months to assess their long-term outcomes. We have enrolled 7627 participants into the trial and we will publish the results of the study in early 2025.

Eligibility criteria

The target population for this trial is patients with severe aortic stenosis undergoing treatment by TAVI.

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the trial
• Aged 18 years or above
• Considered to be candidates for TAVI by the clinical team (via any access route where CEP may be used)
• Participant is suitable for treatment with the cerebral embolic protection device in the opinion of the treating physician