NCT02214277

Cerebral Protection in Transcatheter Aortic Valve Replacement

Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Claret Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The Sentinel System will be a safe and effective method for capturing and removing embolic material (thrombus/debris) during transcatheter aortic valve replacement in order to reduce the ischemic burden in the cerebral anterior circulation.

Detailed description

The Sentinel™ Cerebral Protection System is indicated for use as an embolic capture and retrieval system intended to reduce the ischemic burden in the cerebral anterior circulation while performing transcatheter aortic valve replacement. The objective of this study is to assess the safety and efficacy of the Claret Medical Sentinel Cerebral Protection System used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR) compared to TAVR standard of care (without embolic protection). The study population is comprised of subjects with severe symptomatic calcified native aortic valve stenosis who meet the commercially approved indications for TAVR with the Edwards SAPIEN THV or SAPIEN XT and comply with the inclusion/exclusion criteria.

Conditions

• Severe Symptomatic Calcified Native Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Cerebral Protection System-The SENTINEL System with TAVR	Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
DEVICE	TAVR

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2014-08-12
• Last updated: 2018-05-11
• Results posted: 2018-05-11

Locations

15 sites across 2 countries: United States, Germany