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RecruitingSymptomatic Severe Native Aortic StenosisAortic Stenosis

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

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

Sponsor: MiRus

You may qualify if…

  • ✓ Subjects are eligible for entry in this study if ALL the following conditions are met:
  • ✓ 1. Age ≥ 18 years
  • ✓ 2. 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
  • ✓ 3. New York Heart Association Functional Class ≥ 2
  • ✓ 4. 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)
  • ✓ 5. Eligible for transfemoral delivery of a TAVR
  • ✓ 6. 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)
  • ✓ 7. Understands the study requirements and the treatment procedures and provides written informed consent

You may not qualify if…

  • ✕ Subjects will be excluded for entry in this study if ANY of the following conditions are met:
  • ✕ Anatomical
  • ✕ 1. Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
  • ✕ 2. 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)
  • ✕ 3. Pre-existing prosthetic heart valve or ring except in the mitral position.
  • ✕ 4. Unicuspid aortic valve
  • ✕ 5. Severe aortic regurgitation (\>3+)
  • ✕ 6. Severe mitral or severe tricuspid regurgitation(\>3+) requiring intervention.

Where it's recruiting

Georgia

Atlanta

Source: ClinicalTrials.gov · NCT07278310 · last updated 2026-04-09