Extreme-Risk Patient Enrollment Completed in Medtronic's CoreValve US Pivotal Trial

January 24, 2012—Medtronic, Inc. (Minneapolis, MN) announced that it has completed patient enrollment for the extreme-risk study in its CoreValve US pivotal trial.

The company also received approval from the US Food and Drug Administration (FDA) for an extended investigation granted under the FDA's Continued Access Policy to continue enrolling extreme-risk patients under a Continued Access Study protocol. In the trial's second study evaluating high-risk patients for aortic valve surgery, completion of enrollment is expected later this year.

Medtronic stated that the CoreValve US trial is evaluating the self-expanding CoreValve system in three sizes (26, 29, and 31 mm) and using three delivery routes: transfemoral, subclavian, and direct aortic access.
 

According to the company, the trial is enrolling more than 1,500 patients at 45 clinical sites in the United States. Approximately two-thirds of enrolled patients will be in the high-risk study. Patients in the extreme-risk study are being evaluated against a performance goal derived from contemporary studies. Patients in the high-risk group are being randomized one-to-one to either transcatheter aortic valve implantation with the CoreValve system or to surgical aortic valve replacement. The trial's national Coprincipal Investigators are David H. Adams, MD, and Jeffrey J. Popma, MD.

“The CoreValve trial investigators are very encouraged by our experience using the investigative CoreValve system to treat patients with severe aortic stenosis, and we are eager to fulfill the requirements of the trial in hopes of offering the valve to more patients in the future,” commented Dr. Adams. “With its varying sizes and vascular access routes, the CoreValve system provides flexibility that we hope will accommodate most patients' anatomical circumstances.” 


Additional information about the trial is available on Medtronic's CoreValve trial Web site.