Medtronic has announced that it has completed high risk patient enrolment in its CoreValveUS pivotal trial. More than 1,500 patients with severe aortic stenosis who are at high or extreme risk for aortic valve surgery have been included. In addition, Medtronic received FDA conditional approval to begin evaluating the CoreValve System in patients at intermediate risk for open-heart aortic valve replacement as part of the SURTAVI trial (Surgical replacement and transcatheter aortic valve implantation). The company expects to begin US patient enrolment within weeks.
“With a sizeable population of Americans with severe aortic stenosis who have varying degrees of risk for open-heart aortic valve replacement surgery, the CoreValve US pivotal trial and SURTAVI are landmark trials that will provide critical insights about the appropriate use of the self-expanding CoreValve System,” said David H Adams, chair of the Department of Cardiothoracic Surgery at The Mount Sinai Medical Center and national co-principal investigator of both the CoreValve US pivotal trial and SURTAVI trial. “We are optimistic and eager to fulfill the requirements of both trials with the goal of effectively demonstrating the value of CoreValve as an alternative to open-heart valve replacement surgery.”
The company continues to enrol extreme risk patients in the CoreValve US pivotal trial as part of the FDA Continued Access Policy and is seeking approval to continue enrolling high risk patients under this policy.
About the CoreValve US pivotal trial
The CoreValve US pivotal trial has enrolled more than 1,500 patients in two studies (high and extreme risk) at 45 leading clinical institutions across the USA. Approximately two-thirds of trial patients are in the high risk study. The primary endpoint for the high risk study is freedom from all-cause death at 12 months, and the primary endpoint for the extreme risk study is freedom from all-cause death or major stroke within 12 months.
About the SURTAVI trial
The SURTAVI trial is the largest global, randomised, controlled trial on transcatheter aortic valve implantation (TAVI) and will evaluate approximately 2,500 patients. The trial will evaluate the potential for the CoreValve System to be considered for less-sick patients who typically are treated with open-heart surgical aortic valve replacement today (SAVR). Within the SURTAVI trial, CoreValve implantation can be performed by transfemoral, subclavian or direct aortic access, depending on the needs of the patient. Selection of intermediate risk surgical patients will be based on the Society of Thoracic Surgeons (STS) mortality risk of ≥4% and ≤10% and the study’s primary endpoint will be a composite of all-cause mortality and disabling stroke at 24 months. All patients will be followed through five years. US principal investigators are David Adams; Jeffrey Popma, director, Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston; and Michael Reardon, chief of cardiac surgery at the Methodist DeBakey Heart & Vascular Center in Houston.