Phase 2 of REFLECT Trial Begins for Keystone Heart’s TriGuard 3 Embolic Protection Device
June 18, 2018—Keystone Heart Ltd. recently announced the launch of phase 2 of the REFLECT trial to evaluate the safety and efficacy of the company's next-generation TriGuard 3 cerebral embolic protection device for use during transcatheter aortic valve replacement (TAVR). Keystone Heart is headquartered in Israel with United States operations in Tampa, Florida.
REFLECT is a multicenter, prospective, randomized, clinical study designed to assess the safety and efficacy of comprehensive cerebral protection from emboli released during cardiovascular procedures.
According to the company, phase 1 of the REFLECT trial, which remains blinded, enrolled 258 patients and utilized the TriGuard HDH, an earlier-generation device that has received CE Mark approval in the European Union.
In Keystone Heart's announcement, REFLECT study chairman Jeffrey Moses, MD, stated that enrollment has been initiated for up to 275 additional patients in phase 2 of the trial. Dr. Moses advised that this trial is designed to definitively address the role of comprehensive cerebral embolic protection in improving the safety of the TAVR procedure. Trial completion is targeted for October 2018 and will be followed by submission to the US Food and Drug Administration. Currently, the TriGuard 3 device is for investigational use only, and is not yet commercially available in the United States.