MiRus Begins Patient Enrollment in STAR Trial for Siegel Transcatheter Aortic Valve

The trial will evaluate the safety and effectiveness of the Siegel heart valve in patients with severe aortic stenosis.

Apr. 9, 2026 at 1:51am

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A highly detailed, translucent X-ray photograph revealing the complex internal structure of a transcatheter aortic heart valve, with its delicate components and intricate design visible as ghostly, glowing lines against a dark background, conceptually illustrating the innovative medical technology being evaluated in a clinical trial.An advanced transcatheter heart valve technology aims to improve outcomes for patients with severe aortic stenosis.Marietta Today

MiRus, a life sciences company based in Marietta, Georgia, has announced the successful enrollment and treatment of the first patients in the STAR Trial, a prospective, multicenter, randomized controlled trial studying the Siegel 8-Fr aortic transcatheter heart valve (THV). The trial will evaluate the safety and effectiveness of the Siegel heart valve in patients with severe, symptomatic aortic stenosis who are considered low, intermediate or high risk for surgical complications.

Why it matters

The STAR Trial is an important step in improving treatment options for patients with aortic stenosis, as TAVR has become the standard of care across risk profiles. The study aims to evaluate next-generation devices and techniques that can minimize risks such as stroke, bleeding, pacemaker dependency, and optimize valve longevity, especially in younger, lower-risk patients.

The details

The STAR Trial will enroll 1025 patients across multiple centers in the US, who 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. The Siegel valve is designed with a low delivery system profile and excellent hemodynamics, made possible by the unique properties of the nickel-free Rhenium alloys pioneered by MiRus.

  • The first procedures were performed on April 8, 2026 at Piedmont Heart Institute.
  • The STAR Trial will enroll 1025 patients across multiple centers in the US.

The players

MiRus, LLC

A life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease.

Pradeep K. Yadav, MD

Director of Structural Interventions at Piedmont Heart Institute and National Co-Principal Investigator of the STAR Trial.

Vinod H. Thourani, MD

Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center at Piedmont Heart Institute, and National Co-Chairman of the STAR Trial.

Martin Leon, MD

STAR Trial Chairperson.

Raj Makkar, MD

National Principal Investigator of the STAR Trial.

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What they’re saying

“The initiation of this trial marks a critical step toward improving the treatment options for patients with aortic stenosis.”

— Pradeep K. Yadav, MD, National Co-Principal Investigator STAR Trial

“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!”

— Vinod H. Thourani, MD, National Co-Chairman STAR Trial and Marcus Chairman of Cardiovascular Surgery and the Marcus Valve Center, Piedmont Heart Institute

What’s next

The STAR Trial will continue to enroll patients across multiple centers in the US, with the primary endpoint of the study being a composite of mortality, stroke, and cardiovascular hospitalization at 1 year.

The takeaway

The STAR Trial represents a significant advancement in the treatment of aortic stenosis, as it evaluates a novel transcatheter heart valve that aims to minimize risks and optimize outcomes for patients, particularly those at lower risk for surgical complications. The successful enrollment and treatment of the first patients is an important milestone in this important clinical study.