MiRus has enrolled and treated the first patients in the Siegel transcatheter aortic valve replacement (STAR) trial evaluating the Siegel 8-French aortic transcatheter heart valve (THV) for severe, symptomatic aortic stenosis across various risk categories.
The initial procedures took place at Piedmont Heart Institute, performed by structural interventions director Pradeep Yadav, and cardiovascular surgery marcus chairman Vinod Thourani.
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The main objectives of the randomised controlled, multi-centre, prospective trial are to evaluate the effectiveness and safety of the THV in patients considered low, intermediate, or high risk for surgical complications.
The device’s low-profile delivery and haemodynamic performance are attributed to MiRus’ nickel-free Rhenium alloys, offering fatigue resistance, high yield strength and minimal recoil.
The trial is chaired by Martin Leon and Vinod Thourani, with national principal investigators, including Philippe Genereux, Pradeep Yadav, Raj Makkar, and Samir Kapadia.
It will enrol 1,025 patients across multiple US centres, randomising them 1:1 to either the Siegel THV or a commercially available balloon or self-expanding THV.
The primary endpoint examines a composite of mortality, stroke and cardiovascular hospitalisation at one year.
Yadav said: “The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis.
“As TAVR becomes 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.”
Thourani said: “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.”
