Valvular & structural heart disease
Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial
Study context
- Population
- Adults scheduled for transcatheter aortic valve implantation (TAVI) at specialist cardiac centres across the UK, able to receive the cerebral embolic protection (CEP) deviceplanned
- Participants
- 7,730 adults
- Planned comparison
- TAVI with CEP vs TAVI without CEP
- Primary endpoint
- Incidence of stroke
- Follow-up
- 72 hours post-TAVI
Methodological detailsprospective, open-label, outcome-adjudicated, multicentre, 1:1 randomisation, Sample size 7,730 gives 80% power to detect a 33% relative risk reduction from 3% primary-outcome incidence in controls, Recruitment commenced October 2020; 3,068 enrolled as of October 2022
- Prospective
- Open-label
- Outcome-adjudicated
- Multicentre
- 1:1 randomisation
- Sample size 7,730 gives 80% power to detect a 33% relative risk reduction from 3% primary-outcome incidence in controls
- Recruitment commenced October 2020; 3,068 enrolled as of October 2022
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial. EuroIntervention. Published 24 April 2023. doi:10.
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