transShield Embolic Protection System Feasibility Study

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).

Clinical Trial Description

This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04585308
Study type	Interventional
Source	TransAortic Medical, Inc.
Contact
Status	Completed
Phase	N/A
Start date	December 15, 2020
Completion date	March 13, 2023

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