A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant
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
• Willing and capable to provide informed consent;
• 70 years of age or older;
• 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.
• Symptomatology due to native aortic stenosis resulting in a New York Heart Association (NYHA) functional classification of II or greater.
• Aortic valve annular diameter ≥ 21 and ≤ 23mm measured by MSCT (Multi-Slice Computed Tomography).
• 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%.
• Geographically available and willing to comply with follow up.