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

Recruiting now · Not applicable

Conditions studied: Symptomatic Severe Native Aortic Stenosis, Aortic Stenosis

In brief

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

Key facts

Study ID

NCT07278310

Run by

MiRus

People needed

1025

Starts

2026-04-01

Expected to finish

2028-04-01

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects are eligible for entry in this study if ALL the following conditions are met:
• 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.

You may not qualify if…

• Subjects will be excluded for entry in this study if ANY of the following conditions are met:
• Anatomical
• 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)
• Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment.
• Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5.5 cm or greater or ascending aortic aneurysm defined as maximal luminal diameter 5 cm or greater.
• Clinical
• Evidence of an acute myocardial infarction ≤ 30 days before enrollment.
• Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
• Blood dyscrasias as defined: leukopenia (WBC < 3000 cell/mL, anemia (Hgb < 9 g/dL), thrombocytopenia (platelet count < 50,000 cells/mL), history of bleeding diathesis or coagulopathy.
• Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
• Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support within the past 30 days.
• Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of enrollment
• Need for emergency surgery for any reason
• Ventricular dysfunction with left ventricular ejection fraction (LVEF) < 25% as measured by resting echocardiogram
• Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
• Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy, or end stage renal disease requiring chronic dialysis
• GI bleeding within the past 3 months

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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