NCT02895737

PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 328 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs. self-expandable valves by using a cerebral protection system (Sentinel™ Device).

Conditions

• Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves

Interventions

Type	Name	Description
DEVICE	TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra
DEVICE	TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems
DEVICE	TAVI: CoreValve® Evolut R™, CoreValve Medtronic
DEVICE	TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems

Timeline

• Start date: 2016-12-28
• Primary completion: 2021-12-01
• Completion: 2022-06-01
• First posted: 2016-09-12
• Last updated: 2021-03-04

Locations

1 site across 1 country: Germany