The REFLECT Trial
Research type
Research Study
Full title
The Reflect Trial: A Randomized Evaluation oF the TriGuard™ HDH Embolic Deflection Device to reduce the impact of cerebral embolic LEsions after transCatheter aortic valve implanTation
IRAS ID
188048
Contact name
Andreas Baumbach
Contact email
Sponsor organisation
Keystone Heart Research and Development Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The Keystone Heart TriGuard HDH 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 (TAVI). The primary goal of the study is to assess the safety, efficacy, and performance of the TriGuard HDH embolic deflection device in patients undergoing transcatheter aortic valve implantation (TAVI), in comparison with patients undergoing unprotected TAVI. This prospective, single-blind, randomized, multicenter safety and efficacy trial will enroll up to 285 evaluable subjects and up to 90 roll-in subjects at up to 30 total investigational sites. Subjects will be randomized 2:1 to either TAVI with Triguard, or TAVI without Triguard deflection device. All subjects will be followed clinically in-hospital and at 30 and 90 days.
REC name
South West - Frenchay Research Ethics Committee
REC reference
16/SW/0109
Date of REC Opinion
25 Apr 2016
REC opinion
Favourable Opinion