Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation (REFLECT)

What is the purpose of this trial?

The Keystone Heart TriGuardâ„¢ device is an aortic embolism deflection device intended to reduce the amount of embolic material that may enter the carotid, subclavian, and vertebral arteries during transcatheter heart valve implantation.

The objective of the study is to assess the safety and efficacy of the TriGuardâ„¢ embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with an active control group of patients undergoing unprotected transcatheter aortic valve implantation (TAVI).

Subjects with indications for transcatheter aortic valve implantation (TAVI) and who meet study eligibility criteria will be randomized 2:1 to one of two treatment arms: 1) Intervention: Embolic protection device (TriGuardâ„¢) with transcatheter aortic valve implantation or 2) Control: Unprotected transcatheter aortic valve implantation.


Participation Guidelines

Ages: 18 years and older

Gender: Both


Keystone Heart, Inc.

Start Date: 10/06/2016

End Date: 12/31/2016

Last Updated: 05/15/2019

Study HIC#: 1512016899

Get Involved

For more information about this study, contact:
Marianne McCarthy
+1 203-737-8319
marianne.mccarthy@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

John Forrest

Principal Investigator

Sub-Investigators