Edwards Lifesciences has begun enrolling patients into the PREVAIL Japan clinical trial to study the safety and efficacy of transcatheter aortic heart valves, specifically its Sapien XT.
According to Irvine, Calif.-based Edwards, the trial will assess the Sapien XT valve on patients who are diagnosed with severe aortic stenosis. The Sapien XT uses a cobalt chromium balloon-expandable frame.
During the trial, researchers will evaluate the Sapien system combined with two delivery systems: the NovaFlex transfemoral and the Ascendra 2 transapical.
The company said that three Japanese centers will take part in the trial: Osaka University Hospital in Osaka, Sakakibara Heart Institute in Tokyo and Kurashiki Central Hospital in Okayama.
According to Edwards, the results of the trial will be available in 2013.