NCT05684146

Protect the Head to Head Study

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Emboline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Embolism

Interventions

Type	Name	Description
DEVICE	Emboliner Embolic Protection	Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
DEVICE	Sentinel Cerebral Protection	The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions

Timeline

• Start date: 2023-05-04
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2023-01-13
• Last updated: 2023-05-19

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study