Pivotal REFLECT Study Begins for Keystone Heart's TriGuard Embolic Deflection Device

June 17, 2016—Keystone Heart Ltd. announced enrollment of the first patient in the pivotal United States REFLECT study to evaluate the safety and efficacy of the company’s TriGuard embolic deflection device. The device, which is not yet commercially available in the United States, is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve replacement (TAVR), minimizing the risk of cerebral damage.

In the company’s press release, Raj Makkar, MD, stated, “Neurologic damage due to TAVR is overlooked, and stroke is one of the most devastating complications after these procedures. In this new study of TriGuard, we hope to reduce the risk of neurological damage, and are pleased with the success of the first patient at this time.” Dr. Makkar is Director of Interventional Cardiology, Cardiac Catheterization Laboratory, at Cedars-Sinai Heart Institute in Los Angeles, California.

Jeffrey Moses, MD, the Study Chair of REFLECT, is presenting the clinical trial strategy for REFLECT at the Transcatheter Valve Therapies (TVT) conference, which was held June 16–18 in Chicago, Illinois.

According to the company, REFLECT is a multicenter, phase 2/3, randomized, interventional single-blind clinical study. The study will enroll up to 285 patients in approximately 30 centers internationally. The study will evaluate the safety and efficacy of the TriGuard embolic deflection device in patients undergoing TAVR compared to an active control group of patients undergoing unprotected TAVR. The primary outcome measures are a VARC-2–defined combined safety endpoint at 30 days and hierarchical composite efficacy endpoint determined by all-cause mortality or any stroke, National Institutes of Health Stroke Scale or Montreal Cognitive Assessment worsening, and total volume of cerebral ischemic lesions detected by diffusion-weighted magnetic resonance imaging at 2 to 5 days after the procedure. The data are expected to be available in the first half of 2017.

In the company’s announcement, Dr. Moses commented, “The risk of stroke and other neurological damage is a very serious, yet potentially preventable complication associated with TAVR and other cardiovascular procedures. Through research of devices such as TriGuard, we hope to prevent future TAVR patients from experiencing complications that can have a grave impact on how they are able to function in their daily lives.” Dr. Moses is Professor of Medicine at Columbia University College of Physicians and Surgeons and Director of Interventional Cardiac Therapeutics at NewYork-Presbyterian Hospital/Columbia University Medical Center in New York, New York, and Director of Advanced Cardiac Therapeutics at St. Francis Heart Center in Roslyn, New York.

Also at the TVT Conference, Joachim Schofer, MD, from Albertinen Heart Center in Hamburg, Germany, will present data that laid the groundwork for the REFLECT study. The data demonstrated significantly reduced stroke rates, as well as significantly reduced total lesion volume, for patients using TriGuard compared to those who were unprotected. These data are based on a pooled analysis of three trials with a total of 142 patients undergoing TAVR with TriGuard (n = 59) versus no protection (n = 83), which was presented in May by Alexandra J. Lansky, MD, at the EuroPCR 2016 conference in Paris, France.