IRB Study Number 24-1076
Status Recruiting
Institute Heart and Vascular Institute
Description
The primary objective is to assess the acute and long-term safety and feasibility of the Siegel TAVR device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement.
Inclusion Criteria
Symptomatic, severe native aortic stenosis in subjects 50 years or older AVA ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2 and 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).
Exclusion Criteria
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.
