First Patient Treated in Pivotal APOLLO Trial of Medtronic's Intrepid TMVR System
October 23, 2017—Medtronic announced the first patient implantation in the pivotal APOLLO trial, which is designed to evaluate the safety and efficacy of the company's Intrepid transcatheter mitral valve replacement (TMVR) system in up to 1,200 patients with severe, symptomatic mitral valve regurgitation. The first patient in the APOLLO trial underwent implantation of the Intrepid device at Aurora St. Luke's Medical Center in Milwaukee, Wisconsin.
According to the company, the APOLLO trial design consists of two cohorts and will be conducted at up to 60 sites to evaluate two distinct patient populations. The primary endpoint in both cohorts of the trial is a composite endpoint rate of all-cause mortality, all-stroke, reoperation (or reintervention), and cardiovascular hospitalization at 1 year. Secondary endpoints will measure quality of life and valve performance in patients with severe symptomatic mitral regurgitation.
The randomized cohort will enroll up to 650 patients who are candidates for conventional open mitral valve replacement surgery and not eligible for mitral repair. These patients will be evenly randomized to receive either the Intrepid TMVR system or conventional mitral valve surgery. The primary endpoint is designed to demonstrate the Intrepid TMVR system is statistically noninferior to conventional surgery at 1 year.
The single-arm cohort will enroll up to 550 patients who are considered too high a risk for conventional open-heart mitral valve surgery as determined by a multidisciplinary heart team and will be assigned to undergo TMVR with the Intrepid system. The primary endpoint of this cohort is designed to demonstrate statistical noninferiority to a performance goal at 1 year.
The study is being conducted through an investigational device exemption from the US Food and Drug Administration. The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical studies, advised Medtronic.
David H. Adams, MD, who serves as national coprincipal investigator of the APOLLO trial, commented in the company's announcement, "This is the beginning of an important journey to establish a truly less invasive approach to treat severe mitral valve regurgitation in patients who are appropriate candidates for mitral valve replacement with a transcatheter technology that eliminates the need for open-heart surgery."
APOLLO national coprincipal investigator Martin Leon, MD, added, "The Intrepid system features a truly innovative dual-stent design and the trial will investigate its safety and efficacy in addressing severe symptomatic mitral regurgitation replacing the need for an open-heart procedure. We look forward to working with the APOLLO trial clinical sites in the United States and around the world."