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Protect the Head to Head Study — ProtectH2H  

Embolism Clinical Trial

Official title:
Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device

Clinical Trial Summary

Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05684146
Study type Interventional
Source Emboline
Contact Laura A Brenton
Phone +1 313 919 8044
Email lbrenton@emboline.com
Status Recruiting
Phase Phase 2
Start date May 4, 2023
Completion date December 2024
View Details
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