STAR Trial (Siegel Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis)
To evaluate the safety and efficacy of Siegel™ TAVR System in the treatment of subjects with symptomatic severe native aortic stenosis.
⁃ 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.