The CoreValve US Trial will investigate the self-expanding CoreValve system in three sizes (26mm, 29mm and 31mm) and using three delivery access routes: through the transfemoral artery in the upper leg, through the subclavian artery beneath the collar bone, and through the aorta via minimally invasive surgical incision.
The trial has enrolled more than 1,500 patients in 45 US clinical sites, with approximately two-thirds of patients in the high risk study, who are being randomized one-to-one to either transcatheter aortic valve implantation with the CoreValve system, or to surgical aortic valve replacement.
Co-principal investigator of the study David H Adams said with its varying sizes and vascular access routes, the CoreValve system provides flexibility that will accommodate most patients’ anatomical circumstances.
The US Food and Drug Administration (FDA) has granted approval for an extended investigation to continue enrolling extreme risk patients under a Continued Access Study protocol.
The second study of the trial, which is intended to evaluate high risk patients for aortic valve surgery is expected to complete patient enrollment later this year.
