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The REFLECT Trial: Cerebral Protection to Reduce Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation

Research area:
Valve Disease
Principal investigator:
Robert Stoler, MD, FACC, FSCAI
Type of study:
Interventional

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

“The REFLECT trial involves testing a new cerebral protection device to prevent stroke in patients having TAVR. Stroke is the most devastating complication of TAVR, occurring in approximately 3% of treated patients. Previous trials of cerebral protection used a device that only protected 2 of the 3 great vessels and therefore did not meet its primary endpoint. In REFLECT, a new device which is a longer rectangular "shield' is used to fit across all three major vessels and hopefully capture plaque which could break off from the valve and aorta during TAVR and keep it from embolizing to the brain. This would protect the patient from a potential stroke. If the shield in REFLECT works to reduce embolization, it could be used in a variety of other procedures including open heart surgical AVR and mitral surgeries. We are proud to be one of the few sites in the U.S. to get the opportunity to study this new device,” says Robert Stoler, MD, principal investigator.

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

Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT02536196?cond=NCT02536196&rank=1

Study contact:
Emily Laible, RN, BSN, CCRC, Emily.Liable@BSWHealth.org, 214.820.9903.

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