IRB Study Number 26-216
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study because your doctor has determined your aortic heart valve is not functioning properly and needs to be replaced. The purpose of this study is to find out if the Siegel Transcatheter Aortic Valve Replacement (TAVR) System is effective in treating adults like you who have aortic stenosis. The Siegel TAVR System is an investigational (experimental) device that works by replacing your diseased heart valve without the need for open heart surgery. The valve is put in place through a catheter (small tube) inserted in a puncture in your groin or an incision near your shoulder and is threaded to the heart. It is not approved by the Food and Drug Administration (FDA).
Inclusion Criteria
1) 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).
2) New York Heart Association Functional Class ≥ 2.
3) 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
1) Cardiac anatomy precluding safe placement of a transcatheter aortic valve.
2) 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).
3) Pre-existing prosthetic heart valve or ring except in the mitral position.
