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Trial launched for embolic protection device used during TAVR

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Keystone Heart Ltd. announced that the first patient has been enrolled in a pivotal U.S. regulatory study to evaluate the safety and efficacy of an embolic deflection device.

The multicenter, phase 2/3, randomized, interventional, single blind clinical REFLECT study is designed to assess the safety and efficacy of the embolic deflection device (TriGuard, Keystone Heart), designed to protect the brain from emboli during TAVR procedures, which could reduce risk for cerebral damage, according to a press release issued by the company.

“The risk of stroke and other neurological damage is a very serious, yet potentially preventable complication associated with TAVR and other [CV] procedures,” study chair Jeffrey W. Moses, MD, 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, Roslyn, New York, said in the release.

Jeffrey W. Moses

The study will take place in approximately 30 centers worldwide and will enroll 285 patients. Those assigned the device will be compared with an active control group undergoing TAVR procedures without embolic protection.

According to the release, the primary safety outcome is a combined VARC-2 safety endpoint at 30 days, and the primary efficacy outcome is a hierarchical composite endpoint consisting of 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 2 to 5 days after the procedure.

The company stated in the release that study data are expected to be available early to mid-2017.

“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 said in the release. – by Dave Quaile

Disclosure: Moses reports serving as chair of the steering committee of the REFLECT study and consulting for Abbott and Boston Scientific.