Global APOLLO trial now underway at Lankenau Medical Center with the Intrepid™ TMVR system for patients with severe mitral regurgitation
Main Line Health’s Lankenau Heart Institute is the first in the Philadelphia region to treat a patient in the APOLLO trial—the pivotal trial designed to evaluate the Intrepid™ TMVR system in patients with severe, symptomatic mitral valve regurgitation. As the first-ever pivotal trial for a non-surgical transcatheter mitral valve replacement therapy, the study will evaluate the safety and efficacy of the Intrepid TMVR system in up to 1,200 patients globally.
The first patient treated at Lankenau Heart Institute was implanted by Scott Goldman, MD, director, Structural Heart Program, Lankenau Heart Institute; William Gray, MD, system chief of the division of cardiovascular disease and president of Lankenau Heart Institute; and Sandra Abramson, MD, director, cardiovascular imaging, Lankenau Medical Center.
“We are thrilled to be participating in the APOLLO trial, and hope that this study will prove to be beneficial for patients suffering with severe mitral valve regurgitation,” says Dr. Goldman, who also serves as principal investigator of the trial. “As a leader of cardiac care in the region, Lankenau Heart Institute is honored to be selected as one of only 60 sites worldwide to participate in the trial, further fulfilling our commitment to provide the Philadelphia region with the most advanced heart therapies available.”
Mitral regurgitation occurs when the mitral valve fails to close adequately and allows blood to leak backward each time the heart beats. If left untreated, mitral regurgitation can lead to heart failure or death. The definitive treatment is open heart surgery and valve repair or replacement, but since many of these patients are older and have other medical illnesses, the risk of such surgery can be significant.
The Intrepid TMVR system allows treatment without an open-heart procedure. The valve is a self-expanding replacement tissue heart valve that enables a catheter-based implantation. The Intrepid valve is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve without the need for additional sutures, tethers, or anchors.
“It’s exciting to have the prospect of new technology to arm physicians with when treating mitral valve regurgitation,” says Dr. Gray, who also serves as co-investigator of the trial. “Advances in cardiac treatment such as this will help us to expand the scope of what we can do using interventional approaches for patients with cardiovascular diseases.”
The APOLLO trial design consists of two groups and will be conducted at up to 60 sites to evaluate these two distinct patient populations. The primary endpoint of the trial is a composite endpoint rate of all-cause mortality, all-stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year with secondary endpoints that measure quality of life and valve performance in patients with severe symptomatic mitral regurgitation.
The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical research studies. Other structural heart team physicians included in the trial: Paul Coady, MD; Eric Gnall, DO; Kate Hawthorne, MD; and Roberto Rodriguez, MD.