MiRus has announced enrolment and treatment of the first patients in the STAR trial, a prospective, multicentre, randomised controlled trial studying the Siegel 8Fr aortic transcatheter heart valve (THV). The first procedures were performed at Piedmont Heart Institute by Pradeep Yadav and Vinod Thourani.
The STAR trial will evaluate the safety and effectiveness of the Siegel valve in patients with severe, symptomatic aortic stenosis who are considered low, intermediate or high risk for surgical complications. The combination of low delivery system profile and excellent haemodynamics seen with the Siegel THV is made feasible by the unique properties of the nickel-free Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil, the company says in a press release.
“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis,” says Yadav, who serves as the national co-principal investigator STAR trial. “As TAVI [transcatheter aortic valve implantation] has become standard-of-care across risk profiles, it is vital that we study the next generation of devices and techniques to minimise risks such as stroke, bleeding, pacemaker dependency and optimise valve longevity—especially in younger, lower-risk patients.”
“Our initial experience is very positive,” comments Yadav. “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 haemodynamics are excellent due to the radial strength and porcine pericardial leaflets.”
The STAR trial chairpersons are Martin Leon (Columbia University, New York, USA) and Vinod Thourani (Piedmont Heart Institute, Atlanta, USA). The national principal investigators are Yadav, Raj Makkar (Cedars-Sinai, Los Angeles, USA), Samir Kapadia (Cleveland Clinic, Cleveland, USA), and Philippe Généreux (Morristown Medical Center, Morristown, USA).
STAR will enrol 1,025 patients across multiple centres in the USA. Patients will be randomised 1:1 to receive either the Siegel THV or a commercially available balloon or self-expanding THV. The primary endpoint of the study is a composite of mortality, stroke, and cardiovascular hospitalisation at one year.
“In these first cases, the Siegel valve performance is impressive,” states Thourani. “An 8Fr system with such precise placement, low gradients, and no PVL [paravalvular leak] 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.”
