Israeli medical device company Keystone Heart has initiated the Phase II clinical trial (REFLECT) of its TriGUARD 3 Cerebral Embolic Protection device with the enrolment of the first subject.
TriGuard devices are designed to protect brain reserve from emboli while performing TAVR, surgical valve replacement, atrial fibrillation ablation and other cardiovascular procedures.
This protection is intended to minimise the risk of brain infarcts, stroke and cerebral damage.
The multi-centre, prospective, randomised REFLECT trial will assess the safety and efficacy of the third generation TriGUARD 3 device in around 275 patients.
This clinical study is primarily meant to validate the role of comprehensive cerebral embolic protection to improve the safety during the TAVR procedure.
Keystone Heart president and CEO Chris Richardson said: “We believe that it is imperative to bring a cerebral embolic protection device to the market that: protects all areas of the brain while minimising device interaction; avoids any manipulation of the arch vessels or an additional access site; is anatomy independent for universal patient application; and comes at a price point that will allow broad adoption for the majority of TAVR patients.”
Expected to be completed in October this year, the REFLECT trial follows a Phase I study conducted in 258 patients using the TriGuard HDH device, which gained the European CE-Mark.
Data revealed that brain protection with TriGuard HDH significantly decreased the rate of VARC 2 defined strokes at 30 days and worsening of neurological findings NIHSS. The trial also found a higher incidence of ‘totally clean brains’.