STAR Trial of TAVR With MiRus’ Siegel THV Begins Enrollment

April 9, 2026—MiRus, LLC, announced commencement of enrollment and the treatment of the first patients in the STAR trial of transcatheter aortic valve replacement with the company’s Siegel 8-F transcatheter heart valve (THV).

MiRus stated that the Siegel THV device is composed of nickel-free rhenium alloys, which provide high yield strength, fatigue resistance, and minimal recoil and allow a low delivery profile with excellent hemodynamics.

According to the company, the prospective, multicenter, randomized controlled STAR trial will evaluate the safety and effectiveness of the Siegel THV in patients with severe, symptomatic aortic stenosis who are considered low, intermediate, or high risk for surgical complications.

STAR will enroll 1,025 patients across multiple centers in the United States. Patients will be randomized 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 hospitalization at 1 year, noted the MiRus press release.

The company stated that the STAR trial Chairpersons are Martin Leon, MD, and Vinod Thourani, MD. The National Principal Investigators are Pradeep Yadav, MD; Raj Makkar, MD; Samir Kapadia, MD; and Philippe Genereux, MD.

Dr. Thourani and Dr. Yadav performed the trial’s first procedures at Piedmont Heart Institute in Atlanta, Georgia.

“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis,” commented Dr. Yadav in MiRus’ press release. “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, and pacemaker dependency) and optimize valve longevity—especially in younger, lower-risk patients.”

Dr. Yadav continued, “Our initial experience is very positive. Siegel is much less invasive than 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.”

Dr. Thourani added, “In these first cases, the Siegel valve performance is impressive. An 8-F system with such precise placement, low gradients, and no paravalvular aortic leak is a combination I never expected in THVs. 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!”

In June 2025, the 30-day results from the United States early feasibility study of the Siegel THV were presented by Dr. Yadav and Dr. Makkar at the New York Valves conference.