Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Trial Parameters
Brief Summary
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
Eligibility Criteria
Inclusion Criteria: 1. Willing and capable to provide informed consent; 2. 70 years of age or older; 3. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve Effective Orifice Area (EAO) ≤ 1.0 cm2 or 0.6 cm2/m2, mean aortic valve gradient ≥35 mmHg or peak aortic valve velocity \> 4 m/sec. 4. Symptomatology due to native aortic stenosis resulting in a New York Heart Association (NYHA) functional classification of II or greater. 5. Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography). 6. A STS (Society of Thoracic Surgeons) score ≥ 8; or Logistic EuroScore I ≥ 15; or a determination by the local heart team that the co-morbidities not captured by the STS or EuroScore are expected to increase the operative mortality risk to \> 15%. 7. Geographically available and willing to comply with follow up. Exclusion Criteria: 1. Congenital unicuspid or bicuspid aortic valve; 2. Noncalci