RecruitingNot Applicable

STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)

United States1,025 participantsStarted 2026-04

Plain-language summary

To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25
✓. New York Heart Association Functional Class ≥ 2
✓. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
✓. Eligible for transfemoral delivery of a TAVR
✓. Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2)
✓. Understands the study requirements and the treatment procedures and provides written informed consent
✓. Subject agrees to complete all required scheduled follow-up visits.

✕. Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
✕. Iliofemoral vessel characteristics (vessel diameter \<5.5mm for smaller THV systems \[20-26mm valve sizes\] or \<6.0mm for larger THV systems \[29mm or larger valve sizes\]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)
✕. Pre-existing prosthetic heart valve or ring except in the mitral position.
✕. Unicuspid aortic valve
✕. Severe aortic regurgitation (\>3+)
✕. Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.
✕. Moderate to severe mitral stenosis.
✕. Hypertrophic obstructive cardiomyopathy (HOCM)

All-cause mortality, all stroke and cardiovascular rehospitalization

Timeframe: 1 Year

NCT IDNCT07278310

SponsorMiRus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years
✓. Symptomatic, severe native calcific aortic stenosis in subjects at low, intermediate or high surgical risk AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 or Jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or dimensionless Index \<0.25
✓. New York Heart Association Functional Class ≥ 2
✓. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team (composed of an experienced interventional cardiologist and an experienced cardiac surgeon)
✓. Eligible for transfemoral delivery of a TAVR
✓. Native aortic annulus suitable for safe placement of Siegel 23mm, 26mm or 29 mm transcatheter heart valve. Preprocedural measurements by TTE and CT of aortic annulus area (23mm: 330- 440 mm2 , 26mm: 430-550 mm2, 29mm: 540-690 mm2)
✓. Understands the study requirements and the treatment procedures and provides written informed consent
✓. Subject agrees to complete all required scheduled follow-up visits.

✕. Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
✕. Iliofemoral vessel characteristics (vessel diameter \<5.5mm for smaller THV systems \[20-26mm valve sizes\] or \<6.0mm for larger THV systems \[29mm or larger valve sizes\]) that would preclude safe placement of commercially available transcatheter aortic valves (SAPIEN 3 or Evolut)
✕. Pre-existing prosthetic heart valve or ring except in the mitral position.
✕. Unicuspid aortic valve
✕. Severe aortic regurgitation (\>3+)
✕. Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.
✕. Moderate to severe mitral stenosis.
✕. Hypertrophic obstructive cardiomyopathy (HOCM)