Embolism Clinical Trial
Official title:
Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures ;
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