Medtronic has treated the first US patient in a global, multicentre clinical trial of its CoreValve system, which is designed to treat patients with severe aortic stenosis who are at intermediate risk of needing open-heart surgery.
Available in three sizes (26mm, 29mm and 31mm), the CE-marked CoreValve device is a transcatheter aortic valve implantation system approved for implantation via the transfemoral, subclavian or direct aortic approaches.
The 2,500-patient based trial, called CoreValve Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI), treated its first patient at Pinnacle Health System in Harrisburg in Pennsylvania, US.
Patients will be randomised in a 1:1 ratio to receive either the CoreValve system or an surgical aortic valve replacement.
Based on the composite primary endpoint of all-cause mortality and disabling stroke at 24 months, the trial will evaluate whether the CoreValve system is non-inferior to surgical aortic valve replacement. All patients will be followed through five years, according to the company.
Methodist DeBakey Heart and Vascular Center cardiothoracic surgery professor and study trial co-principal investigator Michael Reardon said that the trial will provide guidance for physicians who are looking to use less invasive options for treating aortic stenosis.
"The trial may demonstrate that the CoreValve system is beneficial to this broader population of patients who are looking for alternative treatments," Reardon added.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo courtesy of Bobak Ha'Eri.