The STAR trial evaluates the safety and effectiveness of Siegel in treating severe, symptomatic aortic stenosis (AS). These patients are considered low, intermediate or high risk for surgical complications.
Dr. Pradeep K. Yadav and Dr. Vinod H. Thourani performed the first procedures at Piedmont Heart Institute in Atlanta. Yadav also took part in the company’s early feasibility study, for which the company shared findings last summer.
MiRus designed Siegel with a low-profile delivery system and unique properties through proprietary nickel-free Rhenium alloys. The company said the design delivers high-yield strength, fatigue resistance and minimal recoil.
(Learn more about transcatheter heart valves in MassDevice’s Transcatheter Heart Valves Special Report. Go here to download the report for free.)
According to the company, Siegel offers several firsts in transcatheter aortic valve replacement (TAVR), with its 8 Fr delivery sheath allowing less invasive procedures and broader patient access, particularly for women. As the only nickel-free THV system, it allows for the treatment of the 20% of Americans suffering from nickel allergies.
Siegel also offers precise delivery due to a lack of foreshortening and intrinsic commissural alignment. Its dry porcine pericardial leaflets have anti-calcification treatment and it has a pre-mounted valve on the balloon.
MiRus intends to enroll 1,025 patients across multiple centers in the U.S. for the STAR trial. It expects to randomize patients 1:1 to receive either Siegel or a commercially available balloon- or self-expanding THV. Other valves for AS include Edwards’ Sapien and Medtronic’s Evolut FX.
The study has a primary endpoint comprising a composite of mortality, stroke, and cardiovascular hospitalization at one year.
Commentary from investigators of the MiRus Siegel THV
In a news release, Yadav said:
“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis. As TAVR has becomes standard of care across risk profiles, it is vital that we study the next generation of devices and techniques to minimize risks such as stroke, bleeding, pacemaker dependency and optimize valve longevity – especially in younger, lower-risk patients. Our initial experience is very positiv. Siegel is much less invasive then current devices and can be placed very precisely due to the lack of foreshortening. This should lead to lower pacemaker rates. The hemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”
Thourani added:
“In these first cases, the Siegel valve performance is impressive. An 8 French system with such precise placement, low gradients, and no PVL is a combination I never expected in THV. A THV without nickel is also much needed. The STAR trial is the most exciting trial in the management of aortic stenosis in the last decade.”
