First Patient Enrolled in New Study to Protect the Brain During TAVR

Keystone Heart Ltd., an emerging medical device company focused on developing cerebral protection devices for patients undergoing cardiac procedures, has enrolled the first patient in a U.S. regulatory study to evaluate the safety and efficacy of the company’s heart TriGuard embolic deflection device.

The device is being assessed for its ability to protect the brain from emboli during transcatheter aortic valve replacement (TAVR), minimizing the risk of cerebral damage.

The study, “TriGuard Embolic Deflection Device to Reduced Impact of Cerebral Embolic Lesions After Transcatheter Aortic Valve Implantation (REFLECT)” is a multicenter, Phase 2/3, randomized interventional single-blind clinical study that will enroll up to 285 patients in approximately 30 centers internationally.

“The risk of stroke and other neurological damage is a very serious, yet potentially preventable complication associated with TAVR and other cardiovascular procedures,” Jeffrey Moses, MD, the study chair said in a statement. “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.”

Moses is professor of medicine at Columbia University College of Physicians and Surgeons, director of interventional cardiac therapeutics at NewYork-Presbyterian Hospital/Columbia University Medical Center, and director of advanced cardiac therapeutics at St. Francis Heart Center in Roslyn, NY. He will present the clinical trial strategy for REFLECT this week at the Transcatheter Valve Therapies conference in Chicago.

Also at the conference, Joachim Schofer, MD, PhD, of Albertinen Heart Center in Hamburg, Germany will share data that laid the groundwork for this study demonstrating significantly reduced stroke rates, as well as significantly reduced total lesion volume, for patients using TriGuard compared to those who were unprotected.

The data is based on a pooled analysis of three trials with a total of 142 patients undergoing TAVR with TriGuard (N=59) vs. no protection (N=83), as previously presented at EuroPCR 2016.

The primary outcome measure includes combined safety endpoint at 30 days (VARC-2 defined), 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 (DW-MRI), 2 to 5 days post-procedure, according to Keystone.

The data are expected to be available in the first half of 2017.