Cerebral Protection in Transcatheter Aortic Valve Replacement

Severe Symptomatic Calcified Native Aortic Valve Stenosis Clinical Trial

Official title: Cerebral Protection in Transcatheter Aortic Valve Replacement - The SENTINEL Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Severe Symptomatic Calcified Native Aortic Valve Stenosis

• NCT number: NCT02214277
• Study type: Interventional
• Source: Claret Medical
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Completion date: June 2016